ML20046B579
| ML20046B579 | |
| Person / Time | |
|---|---|
| Issue date: | 06/10/1993 |
| From: | Chilk S NRC OFFICE OF THE SECRETARY (SECY) |
| To: | |
| Shared Package | |
| ML20046B572 | List: |
| References | |
| FRN-58FR33396, RULE-PR-30, RULE-PR-32, RULE-PR-35 NUDOCS 9308050182 | |
| Download: ML20046B579 (88) | |
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[7590-01]
NUCLEAR REGULATORY COMMISSION 10 CFR Parts 30, 32, and 35 RIN: 3150 - AD69 l
PreparF. tion, Transfer for Commercial Distribution, and Use of Byproduct Material for Medical Use AGENCY:
Nuclear Regulatory Commission.
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ACTION:
Propcsed rule.
SUMMARY
- The Nuclear Regulatory Comaission (NRC) is proposing to amend its l
regulations for the medical use of byproduct inaterial.
This action is being taken in response to a petition for rulemaking. The proposed rule is intended l
to provide greater flexibility by allowing properly qualified nuclear pharmacists and authorized users who are physicir:a greater discretion to prepare radioactive drugs containing byproduct material for medical use.
The i
proposed rule would also allow research involving-human subjects using byproduct material and the medical use of radiolabeled biologics.
In addition, the proposed rule also contains other miscellaneous and confor.aing amendments necessary to clarify or update the current regulations.
DATE: The comment period expires (120 days following publication in the Federal Register).
Comments received after this date will be considered if it is practical to do so, but the Commission is able to assure consideration only for comments received on or before this date.
9308050182 930616 PDR PR 30 MISC PDR
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ADDRESSES: Mail written comments to the Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555, Attention:
Docketing and Service Branch.
Hand deliver comments to 11555 Rockville Pike, Rockville, Maryland, j
between 7:45 a.m., and 4:15 p.m. on Federal workdays.
Copies of the draft regulatory analysis and.any public comments received l
on the proposed rule may be examined at:
the NRC Public Document Room, i
2120 L Street, NW. (Lower Level), Washington, DC.
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FOR FURTHER INFORMATION CONTACT: Samuel Z. Jones or Anthony N. Tse, Office of 1
i Nuclear Regulatory Research, U.S. Nuclear. Regulatory Commission, Washington, DC 20555, telephone (301) 492-3738 for Mr. Jones, or (301) 492-3797 for Mr. Tse.
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SUPPLEMENTARY INFORMATION:
BACKGROUND l.
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The Petition for Rulemaking In early 1989, the American College of Nuclear Physicians (ACNP) and the Society of Nuclear Medicine (SNM) approached the NRC staff with concerns that
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the Commission's regulations failed to accommodate the functions and l
responsibilities of the practice of nuclear pharmacy. At the suggestion of 1
the NRC staff, the ACNP and SNM submitted a petition for rulemaking requesting the Commission to amend its regulations to fully recognize the role of licensed nuclear pharmacists and physicians. On September 15, 1989 2
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(54 FR 38239), the Commission published in the Federal Register a notice of l
receipt of a petition for rulemaking for public comment (PRM-35-9).
During the development of the ACNP-SNM petition, one NRC staff member provided substantial assistance in the preparation of the petition, but has not participated in the NRC's resolutson of the petition or in the development of this proposed rule. Another NRC staff member reviewed the petition prior to its formal submittal to the Commission and participated, to some extent, in the NRC's resolution of the petition and in the development of the proposed rule. The Commission, while aware of this background, considered the petition on its own merits.
The NRC reviewed the petition and identified the fo' 4 wing issues:
A.
The petitioners requested that authorized urirs who are physicians (physician authorized users) be given greater flexibility regarding the medical use of radiopharmaceuticals containing byproduct material.
Specifically, the petitioners requested that these physicians be permitted to:
(1) use radiopharmaceuticals to treat diseases that are not listed in the U.S.
Food and Drug Administration (FDA) approved package insert; (2) use methods of administration of radiopharmaceuticals for therapy that are not listed in the i
package insert; (3) use radiopharmaceuticals other than those for which the l
FDA has accepted an Investigational New Drug (IND) or an approved New Drug l
l Application (NDA); (4) prepare radiopharmaceuticals using radionuclide i
generators and reagent kits in a manner other than in accordance with the l
manufacturer's instructions; and (5) compound radiopharmaceuticals in accordance with State law.
B.
The petitioners requested that the NRC recognize the practice of i
nuclear pharmacy by nuclear pharmacists and the certification of nuclear I
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pharmacists by the Board of Pharmaceutical Specialties. Specificalt, the petitioners requested that nuclear pharmacists be permitted to:
(1) compound radiopharmaceuticals as described in State or FDA regulations; (2) compound radiopharmaceuticals whose manufacture and distribution are not regulated by the State or FDA; (3) prepare radiopharmaceuticals using radionuclide generators and reagent kits in a manner other than in accordance with the manufacturer's instructions; (4) produce reagent kits; and (5) distribute radiopharmaceuticals that are not regulated by the FDA.
C.
Additionally, the petitioners requested that the NRC:
(1) permit categories of research using radioactive drugs that do not require a1 IND, i
such as research approved by a Radioactive Drug Research Committee (RDRC);
i (2) permit the use of radiolabeled biologics for which the FDA has issued a license in response to a product license application (PLA); and (3) clarify its regulations pertaining to specific licenses of broad scope.
In response to the Federal Register notice that announced the receipt of the petition, 466 comment letters were received. About 99 percent of the commenters supported and agreed with the petition. After consideration-of the public comment letters and consultation with the FDA staff, the Commission determined that some issues should be addressed promptly.
On August 23, 1990 (55 FR 34513), the Commission published an Interim Final Rule to allow, for a period of 3 years, the use of therapeutic radiopharmaceuticals for indications not listed in the package insert and to allow departures from the manufacturer's instructions for preparing diagnostic radiopharmaceuticals using radionuclide generators and reagent kits.
In response to the Commission's request for public comments associated with the Interim Final Rule, eight comment letters were received. Seven letters 4
supported the intent of the rule but disagreed with the recordkeeping requirements contained in the rule. One comment letter sought clarification of the rule. The Interim Final Rule permitted specific departures only at the t
written direction of a physician authorized user, and it does not permit pharmacy-directed departures.
On September 20, 1990, NRC received a " Petition for Reconsideration and for Stay of Action" (Petition for Reconsideration) from Syncor International Corporation (Syncor) regarding NRC's Interim Final Rule. Among other objections, the petition asserted that the rule violates the Atomic Energy Act, the Administrative Procedure Act, and NRC's implementing regulations, and that the recordkeeping requirements of the Interim Final Rule have a direct and negative impact on nuclear pharmacies.
l On October 19, 1990, Syncor also filed a " Petition for Review" with the U.S. Court of Appeals for the District of Columbia Circuit (Syncor International Coro, v. NRC, NO 90-1495). The petition asked the court to I
review and set aside portions of the " Interim Final Rule," especially the recordkeeping requirements in 10 CFR 30.34(i)(1)(1-11).
Also, Syncor requested that the NRC amend its nuclear pharmacy license to permit certain pharmacy-directed departures in addition to the Interim Final Rule's physician-directed departures.
Syncor and the NRC staff agreed to hold the court action in abeyance for a period of several months to give the NRC an opportunity to respond to Syncor's request. After consider;b k interaction among the NRC, Syncor, and the FDA, the requested license amendments for pharmacy-directed departures were granted. Because of the generic interest this licensing action might have had for other commercial l_
nuclear pharmacy licensees, the NRC, on June 26, 1991, sent each of these 1
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1 licensees a letter informing them of the NRC's action in issuing Syncor's amendments. Until the amendments contemplated in this proposed rulemaking are adopted through the issuance of a final rule, the NRC stands ready to. consider similar license amendment requests from other commercial nuclear pharmacies.
l Meanwhile, to provide relief from the recordkeeping requirements 1
contained in the Interim Final Rule, the Commission published a final rule entitled " Departure From Manufacturer's Instructions; Elimination of Recordkeeping Requirements" (57 FR 45566; October 2, 1992). This final rule
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eliminated all the recordkeeping requirements.
Based on the information collected under the Interim Final Rule, both the NRC and FDA staff agreed that the major trends in departures that could be identified by the.recordkeeping l
were already discernible. Thus, additional recordkeeping was not necessary.
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In a parallel effort, the NRC continued to work on the remaining issues in the ACNP-SNM petition. On August 7, 1991, the NRC conducted a public workshop in Rosemont, Illinois, to present "strawman" language on the training i
and experience criteria for authorized nuclear pharmacists to representatives of the following organizations:
Board of' Pharmaceutical Specialties, American 1
Board of Science in Nuclear Medicine, National Association of Boards of Pharmacy, Committee on Radionuclides and Radiopharmaceuticals of the U.S.
l Council for Energy Awareness, American Pharmaceutical Association,- American l
Society of Hospital Pharmacists, and three graduate. schools of pharmacy.
Subsequently, the NRC also discussed the proposed resolution of-these-issues in meetings with the FDA, the NRC's Advisory Committee on-the Medical Uses of Isotopes (ACMUI), and the Agreement States. This proposed rulemaking is the -
evolutionary result of numerous meetings with the aforementioned groups.
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THE PROPOSED MODIFICATIONS In a policy statement published on February 9,-1979 (44 FR 8242),
entitled " Regulation of the' Medical Uses of Radioisotopes; Statement of f
General Policy," the NRC stated:
1.
The NRC will continue to regulate the medical uses of radioisotopes e
3 as necessary to provide for the radiation safety of workers and the. general j
public.
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The NRC will regulate the radiation safety of patients where l
i justified by the risk to patients and where voluntary standards, or compliance 1
with these standards, are inadequate.
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The-NRC will minimize intrusion into medical judgments affecting-patients and into other areas traditionally considered to be a part of the practice of medicine.
i In conformance with this policy, the Commission proposes to eliminate.
certain restrictions in the NRC regulations on the practice of medicine and pharmacy (e.g., compounding), and provide the authority for research involving human subjects and the use of radiolabeled biologics.
The Commission believes that these restrictions can be eliminated without compromising the level. of protection of public health and safety against radiological hazards. The Commission recognizes that physicians have the primary responsibility for the diagnosis and treatment of their patients or human research subjects and
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recognizes that the nuclear pharmacists have the primary responsibility for the preparation of radioactive drugs.
NRC regulations are predicated on the
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assumption that properly trained and adequately informed physicians and pharmacists will make decisions that are in the best interest of their
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4 patients or human research subjects.
Furthermore, the pharmacological aspects 1
of radioactive drugs, including drug safety and efficacy, are regulated by the FDA or the States.
The Commission believes that the proposed amendments would provide greater discretion for physician authorized users to use byproduct material in i
the practice of medicine. Also, the proposed amendments would incorporate t
into the regulations the concept of an authorized nuclear pharmacist to allow properly qualified pharmacists greater discretion to prepare (including compound) radioactive drugs containing byproduct material for medical use.
In response to the petition for rulemaking, the Commission is propcsing to:
1.
Allow physician authorized users to use therapeutic radioactiva drugs containing byproduct material for indications or methods-of administration not listed in the FDA-approved package insert; 2.
Allow physician authorized users to use radioactive drugs containing byproduct material for research involving human subjects; 3.
Allow physician authorized users to use radiolabeled biologics containing byproduct material; 4.
Allow medical use licensees and commercial nuclear pharmacies to depart from the manufacturer's instructions for preparing radioactive drugs using radionuclide generators and reagent kits; 5.
Allow medical use licer. sees and commercial nuclear pharmacies to compound radioactive drugs using byproduct material; 6.
Delete the existing regulations related to the nonradioactive reagent kits; and t
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Clarify regulatory requirements for specific licenses of broad scope.
i Table 1 summarizes the requests made in the petition and the Commission's responses.
In addition to the proposed amendments in response to the issues raised in the petition, the Commission is proposing related or miscellaneous amendments to Parts 32 and 35.
In general, the objective of these proposed amendments is to clarify, update, and simplify the current regulations.
Specifically, these proposed amendments include:
1.
In Part 32, the Commission is proposing to replace the word "radiopharmaceutical" with the term " radioactive drug" in proposed 132.72.
i This change is necessary to include both radiopharmaceuticals and radiolabeled biologics in Part 32.
2.
In Part 35, whenever applicable, the Commission is proposing to use the term " unsealed byproduct material" instead of "radiopharmaceutical" or
" radioactive drug." This proposed change is intended to indicate that the.
1 Commission's regulations regarding the medical use of byproduct material are focused on radiation safety and are separate from'FDA's regulations regarding radioactive drugs.
However, to prevent massive changes in Part 35, the word "radiopharmaceutical" will. continue to be used in existing sections for which no modifications are proposed and for sections in which the only modification is to replace the word " patient" with the term " patient or human research subject." Thus, the word "radiopharmaceutical" will be used as the equivalent of " unsealed byproduct material" in the these sections of the proposed rule.
3.
The Commission is proposing to modify the definition of " medical use" in Parts 30 and 35 by replacing the term " human beings" with the term 9
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Table 1 I
Summary of Requests in the Petition and the Commission's Responses Reauest
Response
Permit authorized users to use Permit physician authorized radiopharmaceuticals for
- users who are qualified for therapeutic uses not covered in therapeutic administration to-the package insert.
use radioactive drugs for therapeutic uses not covered in the package insert.
Permit authorized users to use Permit physician authorized radioactive drugs for research users to use radioactive drugs involving human subjects.
for research, provided that human research subjects are protected.
Permit authorized users to use Permit physician authorized radiolabeled biologics.
users to use radiolabeled biologics, provided that dosages of alpha-or beta-emitting radionuclides are measured.
I Permit medical use licensees and Permit physician authorized pharmacies to depart from users and authorized nuclear package inserts when using pharmacists who meet certain generators and kits.
training and experience criteria to depart from package inserts when using generators and kits.
Permit medical use licensees and Permit physician authorized pharmacies to use byproduct users and authorized nuclear i
material to compound radioactive pharmacists who meet certain drugs.
training and experience criteria to prepare (including compound) radioactive drugs.
Permit nuclear pharmacists to Delete NRC regulations on prepare reagent kits.
reagent kits which do not contain byproduct material.
Thus, nuclear pharmacists would be able to prepare reagent kits under applicable' law.
Clarify requirements on licenses Clarify the requirements by of broad scope.
adding two exemptions in Part 35.
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" patients or human research subjects" to include the administration of byproduct material to an individual who is participating in a research procedure.
In addition, the Commission proposes to delete the language in the definition of " medical use" that the administration of byproduct material be in the practice of medicine in accordance with a license to practice medicine.
The definition of other terms in Part 35 (e.g., physician) include this licensing concept.
With this proposed definition, applicable requirements in Part 35, such as misadministration reporting and quality management program, would also apply to human research subjects; thus, an equivalent level of protection wocid be provided for both patients and human research subjects.
t 4.
In Part 32, the Commission is proposing to clarify the existing regulations regarding the labeling of syringes, vials, generators, or other containers of radioactive drugs. This proposed change is necessary to avoid confusion over the types of information to be submitted.
5.
In Part 32, the Commission is proposing to replace the text in 132.72(b) because it is obsolete.
6.
In discussing the proposed regulations concerning transfer of radioactive drugs, the Commission has noted later in this preamble that it is sometimes necessary to transfer a dosage of a radioactive drug on a case-by-case basis from one medical use licensee to another medical use licensee.
These case-specific transfers would not be considered commercial transfers by the NRC and, therefore, would not require a Part 32 license.
7.
In Part 35, the Commission is proposing to change the lower limit for testing dose calibrators for linearity from 0.37 Megabecquerel 11 l
(10 microcuries) to 1.1 Megabecquerels (30 microcuries) for consistency with 10 CFR 35.32, " Quality Management Program."
8.
In regard to the accuracy, linearity, and geometry testr of dose calibrators, the Commission is proposing to replace the requirement for the Radiation Safety Officer's (RS0) signature with the requirement for the identity of the individual actually performing theso tests. This proposed change is necessary to identify the individual who actually performed these tests.
Furthermore, this change would provide additional time for the RSO to devote to other radiation safety issues. However, this change would not affect the responsibilities of the RSO that are defined in existing 10 CFR 35.21.
9.
The Commission is proposing to update the regulations by recognizing several certification boards in the training and experience requirements.
- 10. The Commission is proposing that licensees may allow authorized users and authorized nuclear pharmacists who meet certain requirements to use byproduct material without the licensee first obtaining a license amendment from the NRC. Therefore, the Commission is proposing to delete the provisions in Part 35 addressing visiting authorized users.
- 11. The Commission is proposing to modify the requirements for recentness of training of certain authorized users.
- 12. The Commission is proposing to add requirements regarding the preparation of byproduct material for medical use under the supervision of a physician authorized user and to provide comparable requirements regarding the supervisory responsibilities of authorized nuclear pharmacists.
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- 13. The responsibilities of the Radiation Safety Committee would be modified to reflect the aethities which the proposed changes to Part 35 would authorize.
DISCUSSION OF PROPOSED REGULATORY TEXT i
Section 30.4.
Definitions.
The definition of " medical use" would be modified to conform to the corresponding definicion preposed for 10 CFR 35.2. This definition would be modified by replacing " patients"'with " patients or human research subjects" to include the administration of byproduct material to an individual who is I
participating in a research procedure.
In addition, the modifications would delete the current statement in j
this definition that the byproduct material be administered in the practice of l
medicine in accordance with a license issued by a State or Territory of the l
1 United States,.the District of Columbia, or the Commonwealth of Puerto Rico.
This change would be made because:
(1) this. aspect of the definition is included in other existing definitions -in Part 35 (e.g., authorized user and physician); and (2) the definition of " medical use" would include research -
involving human subjects.
Section 30.34 Terms and conditions of licenses.
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Section 30.34(i) provided interim relief from the restrictions that licensees follow the manufacturer's instructions when preparingL 13
radiopharmaceuticals using radionuclide generators and reagent kits.
This proposed rulemaking would eliminate these restrictions. Therefore, the Commission proposes to delete 5 30.34(i) in its entirety.
Section 32.72 Manufacture. orecaration. or transfer for commercial distribution of radioactive druos containina byproduct material for medical use under 10 CFR Part 35.
The Commission proposes to retitle this section to more accurately reflect the operations of licensees (i.e., manufacturers and commercial nuclear pharmacies) regulated under this section.
1 Section 32.72(a).
Tnis paragraph would be modified to add the word " prepare" and the i
phrase " transfer for commercial distribution" to more accurately reflect the operations of licensees regulated under this section.
Section 32.72(a)(1).
The proposed amendment to this paragraph is an editorial change to replace "6 30.33 of this chapter" with "10 CFR 30.33."
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Section 32.72(a)(2).
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The Commission proposes to modify this paragraph to recognize radioactive drug manufar,turers holding registration by the FDA, or appropriate State agencies, as well as commercial nuclear pharmacies licensed by State i
Boards of Pharmacy (SBPs) and nuclear pharmacies operating in Federal.
facilities. The intent of this paragraph is to clarify that commercial nuclear pharmacies are covered under this section.
Radioactive drugs transferred from a commercial nuclear pharmacy to another licensee in the normal course of business are considered commercial transfers by the NRC and require a Part 32 license.
However, the Commission recognizes that in the course of patient care or in the conduct of research procedures, it it sometimes necessary for licensees to transfer a dosage of a j
radioactive drug on a case-by-case basis from one medical use licensee to l
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another medical use licensee. These case-specific transfers would not. be l
j considered commercial transfers by the NRC and, therefore, would not require a J
Part 32 license.
l Section 32.72(a)(3).
The Commission proposes to modify this paragraph to clarify the type of information that should be submitted to the NRC. The words " packaging" and
" package" in the existing 5 32.72(a)(3) could be interpreted as referring-
- only to the external transportation package (e.g., cardboard box).
In the proposed 132.72(a)(3)', the words "... per' vial, syringe, generator, or other l
container..." would be used to clearly indicate the types of information to
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be submitted.
In addition, the phrase " group licensees" would be replaced.
with the phrase " medical use licensees."
Section 32.72(a)(4).
The Commission proposes to modify 5 32.72(a)(4)(i) to clarify the types of information that should be contained on the label to be affixed to each i
container of a radioactive drug..This action is proposed to ensure that the' l
information on the label would include' information specified in existing 10 CFR 35.60(b) and 35.el(b).
j Also, the Commission-proposes to replace the phrase "each package" by-the phrase " labels to be applied to containers of radioactive drugs, as l
specified'in 10 CFR 35.60(b) and 35.61(b)..." for the same reason as for the i
proposed changes in 6 32.72(a)(3), discussed above.
In addition, the Commission is also proposing to delete the last l
sentence of 6 32.72(a)(4)(1) because it is obsolete.
Furthermore, " time of assay" would be added to the existing "date of.
assay." This information is necessary for determining the dosage, at the time r
of administration, for radioactive drugs containing radionuclides with short l
i hal f-lives.
i The Commission also proposes to delete the provision in 9 32.72(a)(4)(ii)' that required FDA approval: before combining labeling
.information.
In addition, the remaining phrase of the existing-5 32.72(a)(4)(ii) "the labels, leaflets or brochures required by this paragraph are in. addition to the labeling required by the Food and Drug
- Administration (FDA)" would be replaced by "NRC's labeling requirements are 16 l
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I independent of requirements of the U.S. Food and Drug Administration (FDA)."
This proposed sentence would be moved to the existing I 32.72(a)(4)(1) which would be renamed 9 32.72(a)(4). This proposed amendment would not preclude
.j use of one label if it contains all the required information.
_S_qction 32.72(b).
i The Commission proposes to revise this paragraph because the existing text is obsolete.
The Commission proposes new text that would allow an." authorized nuclear' j
pharmacist" (or individual working under the supervision of'the " authorized nuclear pharmacist") working in a commercial nuclear pharmacy to prepare
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(including compound) radioactive drugs.
The NRC is using the phrase " prepare l
1 radioactive drugs" in a general sense to include:
(1) using radionuclide l
generators and nonradioactive reagent kits to produce radioactive drugs; and (2) using byproduct material and other basic ingredients to compound radioactive drugs.
Current regulations require that.a Part 32 licensee may not depart frcm manufacturer's instructions when preparing radioactive drugs unless:
(1) a i
license amendment has been granted permitting the departure; or (2) the departure has.been requested by a physician authorized user.
This requirement restricts the ability of qualified nuclear. pharmacists to practice their profession which could otherwise include, but for NRC restrictions, compounding radioactive drugs. The NRC believes that this restriction can be eliminated provided that the pharmacist meets the training and experience i
requirements in proposed 10 CFR 35.980.
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1 The Commission is proposing to define the terms " medical use" and
" authorized nuclear pharmacist" in Part 32 by referencing the definition of these terms in proposed 10 CFR 35.2.
The definition of " medical use" would be modified to add the term " human research subject" to include the administration of byproduct material to an individual who is participating in a research procedure.
It is necessary to define an " authorized nuclear pharmacist" because the proposed amendments would provide pharmacists with the authority to possess and use byproduct material in the practice of nuclear pharmacy.
For purposes of Part 32, an authorized nuclear pharmacist also includes those individuals who are currently licensed or registered by a state as a pharmacist and who are also designated, as of the effective date of the final rule, as an " authorized user" on a nuclear pharmacy license issued by the Commission under 10 CFR Part 32 to work as an authorized nuclear pharmacist.
The Commission believes that this limited "grandfathering" is justified because:
(1) currently, these " authorized users" essentially meet the training and experience criteria for an authorized nuclear pharmacist as specified in proposed 10 CFR 35.980(b)(1); and (2) these " authorized users" are currently working in a nuclear pharmacy.
A Part 32 " authorized user" who does not currently possess a valid state pharmacy licensure or registration would not be grandfathered as an authorized nuclear pharmacist because, under state law, this individual is not qualified to be a pharmacist.
However, such an individual may work in a nuclear pharmacy under the supervision of an authorized nuclear pharmacist.
The Commission proposes to require licensees to submit a copy of the i
l individual's board certification, the license, or the permit, and the state 18
i pharmacy licensure or registration to the NRC within 30 days of the date that the licensee permits the individual to work as an authorized nuclear pharmacist. This proposal would reduce the licensees' burden because such a notification would replace the currently required license amendment and the l
associated amendment fee which are currently necessary before a licensee may allow an authorized nuclear pharmacist to work in its facility.
In addition, 4
the proposed action would also eliminate the delay associated with the license i
amendment process. The NRC will review the notifications upon receipt to verify that the requirements of proposed i 32.72(b) have been met. During j
the review process, the NRC can consider an individual's character in addition to credentials in determining whether the individual should be approved as an authorized user or authorized nuclear pharmacist, such as verifying that the individual has not committed or caused others to commit any willful violations of the Commission's regulations. At the time of the next licensing action, the names of approved individuals would be listed on the license, without fee, as an authorized nuclear pharmacist.
Section 32.72(c).
The Commission proposes to add this paragraph to explicitly require Part 32 licensees to measure and record each dosage of radioactive drugs before transferring these drugs to a medical.use licensee. This proposed change is necessary so that the proposed relief to 10 CFR Part 35 medical use licensees with respect to measurements can be granted.
In proposed s 35.53, medical use licensees would not be required to measure unit dosages of alpha-and beta-emitting radioactive drugs obtained from Part 32 licensees before 19
i administering these unit dosages to patients or human research subjects.
l Thus, it is necessary for the Part 32 licensees to make these measurements.
Section 32.72(d).
This paragraph is necessary to remind Part 32 licensees to comply with applicable FDA, other Federal, and State requirements in addition to applicable NRC requirements.
Compliance with NRC requirements does not eliminate the need to comply with other lawful requirements.
However, it is not the intent of the Commission to perform inspections to ensure compliance with FDA or State requir.ements nor to enforce those regulations.
i Section 32.73 Manufacture and distribution of cenerators or reacent kits for oreparation of radiopharmaceuticals containina bvoroduct material.
The Commission proposes to delete this section in its entirety.
Because radionuclide generators would be included as a radioactive drug in proposed 9 32.72, it is no longer necessary to include the generators in 9 32.73.
In addition, the Commission is proposing to discontinue regulating reagent kits because they do not contain byproduct material.
10 CFR Part 35 Medical Use of Bvoroduct Material.
The Commission is proposing to replace the word " patient" with the term
" patient or human research subject" as stated in the sections of Part 35 which the Commission is proposing to amend. However, only those sections of Part 35 20
r which are otherwise being amended are included in the section-by-section l
" Discussion of Proposed Regulatory Text" which follows.
The sections not included in that discussion are:
El 35.2 (the definitions of i
misadministration and written directive), 35.32, 35.33, 35.60, 35.75, 35.310, t
35.315, 35.404, 35.406, 35.410, 35.415, 35.610, and 35.615. The purpose of l
using the phrase " patient or human research subject" is to make it explicit that licensees must follow the requirements of Part 35 whenever byproduct material or radiation therefrom is being administered either to a patient or to a human research subject.
It is necessary to provide an ~ equivalent level-of protection for both patients and human research subjects.
l Section 35.2 Definitions.
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I Authorized nuclear charmacist.
The Commission proposes to add this new i
definition.
It is necessary to define an authorized nuclear pharmacist i
because the proposed amendments would provide pharmacists.the authority to possess and 'use byproduct material in the practice of nuclear pharmacy l
independent of the supervision of a physician authorized user.
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The definition would specify three groups of individuals that would be qualified as authorized nuclear pharmacists:
(1) individuals certified by the Board of Pharmaceutical Specialties (BPS) as a board certified nuclear pharmacist (BCNP),. (2) individuals identified as authorized nuclear pharmacists'on a Commission or Agreement State license, or (3) individuals identified as authorized nuclear pharmacists on a permit issued by a Commission or Agreement State specific licensee of broad scope. The i
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1 individuals in the second and third groups must meet the training and experience requirements specified in the proposed 5 35.980(b).
Authorized user.
The Commission is proposing to modify the definition of " authorized user" to include those individuals who are:
(1) board certified by at least one of the boards listed in Paragraph (a) of s t 35.910, 35.920, 35.930, 35.940, 35.950, or 35.960; (2) identified as an authorized user on a Commission or Agreement State license, or (3) identified as an authorized user on a permit issued by a Commission or Agreement State specific licensee of broad scope. The individuals in the second and third groups must meet the training and experience requirements specified in paragraphs (b) or (c) of Il 35.910 or 35.920, or paragraph (b) of 95 35.930, 35.940, 35.950, or 35.960.
t Proposed 6 35.13 would eliminate, under certain conditions, the requirement for a licensee to submit an amendment to list an authorized user on its license.
Instead, proposed 6 35.14 would require specific licensees of limited scope to provide a copy of the individual's besrd certification, the license, or the permit to the Commission within 30 days of the date that the licensee permits the individual to work as an authorized user.
However, before allowing a physician who does not have board certification (or is not listed on a license or a permit) to work as an authorized user, the specific licensee of limited scope mest continue to submit a license amendment and obtain NRC approval. The NRC will review the notifications upon receipt to verify that the requirements of proposed s 32.72(b) have been met. During the review process, the NRC may consider character in addition to credentials in determining whether the individual should be approved as an authorized user or authorized nuclear pharmacist, 22
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such as to verify that the individual has not committed or caused others to commit any willful violations of the Commission's regulations.
Medical use.
The Commission is proposing to modify the definition of
" medical use" by replacing the term " human beings" with the term "pa'.ients or human research subjec.ts" to include the administravica cf bypredac'. material to an individual who is participating in a research procedure.
Currently, the NRC allows by license condition specific mr: dical use licensees of broad scope to perform research invot human subjects using i
byproduct material. Because Part 35 is silent on research involving human l
1 l
subjects using byproduct material, Part 35 specific medical use licensees of limited scope may only conduct such research if the NRC grants a license l
amendment to do so. The effects of the current regulatory framework are to inhibit or delay research activities by specific medicai ue licensees of limited scope.
Medical research involving human subjects not using radioactive material is currently conducted by large medical institutions and community hospitals through, for example, their participation in regional and national research programs.
Such research may lead to a better understanding of diseases, improved diagnostic and therapeutic methods, new or better drug products or medical devices, or essential basic scientific information.
Current regulations require all medical institutions to have a Radiation l
l Safety Committee whose responsibilities include oversight of all uses of licensed material. Other Part 35 licensees are required to have a Radiation Safety Officer who has such responsibility.
The Commission believes that l
restrictions on research can be reduced provided there are certain additional protections of human subjects as described in proposed 5 35.6.
23 i
The proposed provisions include requiring a licensee who conducts research involving human subjects to:
(a) possess a Part 35 license authorizing medical use, (b) implement the Federal Policy for the Protection of Human Subjects or comply with specific NRC licensing requirements, and (c) have a physician authorized user who will supervise the administration of the byproduct material.
The Commission believes that information gathered through research, although it may not benefit the individual subject of the research, has the potential to benefit the society at large.
Therefore, given adequate protection of the rights and radiological safety of human research subjects, it is appropriate to permit this activity.
Furthermore, under the proposed definition of " medical use," the applicable provisions of Part 35, such as requirements related to misadministrations and the quality management program, also apply to a human research subject. Thus, an equivalent level of protection would be provided for both patients and human research subjects.
The Commission is also proposing to delete the current statement in this definition that the byproduct material be administered in the practice of medicine in accordance with a license issued by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico.
This change is being made because this aspect of the definition is included in other existing definitions in Part 35 (e.g.. authorized user and physician).
Pharmacist.
The Commission is proposing to add this new term to define a pharmacist in Part 35 to complement another new definition " authorized nuclear pharmacist."
24
i Section 35.6 Provisions for'research involvina human sub.iects.
I I
The Commission is proposing to add this section to address the i
protection of the rights of human subjects who would be involved in research using byproduct material. The Commission believes that most research j
involving human subjects using byproduct material is currently conducted, funded, supported', or regulated by another federal agency which has implemented the Federal Policy for the Protection of Human Subjects' (56 FR 28002; June 18, 1991). Therefore, the rights of human subjects involved in such research activities would be protected by the other federal agency funding the research under the provisions of.the Federal. Policy.
The i
Federal Policy has been implemented by 15 Federal-departments or agencies (not -
including NRC) and includes provisions, among others,.for obtaining Institutional Review Board (IRB) review and approval of the research activities and informed consent from the human subjects.
The NRC understands that compliance.with the Federal Policy by institutions conducting research involving human subjects is achieved through the use of letters of assurance 4
of compliance and certain reporting requirements.
This section proposes to allow the licensees covered by the Federal Policy as adopted by another Federal agency to conduct human research without prior NRC approval.
If a licensee's activities are _not funded by another Federal agency which has adopted the Federal Policy, the licensee would need to apply for and obtain approval of a specific amendment to its NRC license prior to conducting research involving human subjects using byproduct 2
For a copy of the Federal Policy for the Protection of Human Subjects contact:
Office for Protection from Research Risks, National Institute of Health, Building 31, Room 5B59, Bethesda, MD 20892, telephone (301) 496-7005.
25
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d material. During the review of the license amendment application, the NRC would ensure that the proposed research would receive approval of the IRB and obtain the human subject's informed consent. The Commission is soliciting public comment on the number and type of research activities which would not be funded by another Federal agency which has adopted the Federal Policy and, thus under the proposed rule, would require a license ameddment.
l The focus of NRC inspections would be to confirm that both types of licensees have obtained prior IRB review and approval. of the'research.
activities and informed consent of the human subjects.
The Commission is soliciting public comment on whether it should broaden or narrow its focus to require compliance with all or none of the provisions of the Federal Policy or equivalent license conditions.
In making comments, consideration should be given to the fact that all the radiation safety provisions of 10 CFR Part 35 are proposed to be made applicable to research involving human subjects.
Section 35.7 FDA. Other Federal. and State reouirements.
f i
This section is necessary to remind medical use licensees 'to' comply with 1
applicable FDA, other Federal, and State requirements. However, it is not the intent of the Commission to perform inspections to ensure compliance with FDA or State requirements nor to enforce those regulations.
i 26 i
Section 35.11 License reouired.
The Commission is proposing to add paragraph (c), in parallel with the existing paragraph (b), to this section.
The new paragraph (c) would permit an individual to prepare unsealed byproduct material for medical use under the supervision of an authorized nuclear pharmacist or authorized user who is a physician. Also, the existing paragraph (a) would be revised by replacing the phrase " paragraph (b)" with " paragraphs (b) or (c)."
Section 35.12 Application for license. amendment. or renewal.
The Commission is proposing to add paragraph (e) to this section.
This paragraph would remind Part 35 medical use licensees that they may apply for a Type A specific license of broad scope under 10 CFR Part 33.
Section 35.13 License amendments.
The Commission proposes to modify paragraph (b) of this section to delete the term " visiting authorized user."
Instead, under the proposed provisions, the licensees could allow, without a license amendment, an i
individual to work as an authorized user provided that the individual is:
(1) certified by a board listed in Subpart J, (2) identified as an authorized user on a Commission or Agreement State license, or (3) identified as an authorized user on a permit issued by a Commission or Agreement State specific i
licensee of broad scope.
However, the licensee would be required to provide a copy of an individual's board certification, the license, or the permit to the 27 l
l
I
?
Commission within 30 days of the date that the licensee permits the individual to work as an authorized user (See proposed 5 35.14).
l The Commission also propr to add an exception for authorized nuclear a
pharmacists to this section like the exception for authorized users.
Section 35.14 Notification.
l In addition to the existing notification requirement, the Commission proposes to amend this section to require specific licensees of limited scope.
to submit a copy of an individual's board certification, the. license, or. the permit as discussed in 135.13. This proposal would reduce licensees' burden because this notification would replace the currently required. license l
amendmeat and the associated amendment fee which are currently necessary I
before a specific licensee of limited scope may allow an authorized user to I
work in its facility.
In addition, the proposed action would also eliminate the delay associated with the license amendment process. The NRC ~will review the notifications upon receipt to verify that the requirements of this section have been met.
In addition, the NRC would verify at th't time that this a
individual has not committed or caused another individual. to commit any willful violations of the Commission's regulations'. At the time of the next licensing action, the name of this individual.would be listed on the license, without fee, as an authorized user. The Commission also proposes,to apply I
this section to authorized nuclear pharmacists in the same manner as for authorized users.
1 28
Section 35.15 Exemotions reaardina Tvoe A specific licenses of broad scoce.
The Commission is proposing to clarify requirements on Type A specific licenses of broad scope by adding the proposed exemptions.
This proposed section would specify that an application for and receipt of a license amendment would not be necessary'for the following actions:
(1) permit a new authorized user or authorized nuclear pharmacist to work under the license; and (2) permit a change of the area of use of byproduct material within the address identifier! in the license.
Also, specific licensees of broad scope would be exer.pt from certain notification requirements specified in proposed l 35.14.
These changes are being made to ensure that the proposed rule conforms with the current practice regarding Type A specific licensees of broad-scope.
Under current practice, the other prescriptive and performance requirements of Part 35 apply to Type A specific licensees of broad scope.
Because a Part 33 specific licensee of broad scope is required to establish more complete administrative procedures and controls to ensure radiation safety than a Part 35 licensee, the exemptions would not reduce protection of public health l
and safety.
l t
l Section 35.22 Radiation Safety Committee.
i l
The Commission is proposing to amend paragraph (b)(2) to apply this.
section to authorized nuclear pharmacists'in the same manner as for. authorized users.
29 i-
.t The Commission also proposes to require the Radiation Safety Committee I
to review an individual's certification, license, or permit, and determine, l
based on the proposed i 35.13(b)(1) through (b)(4), whether to allow the indiv521 to work as an authorized user or authorized nuclear pharmacist without submitting a license amendment for NRC approval.
i Section 35.25 Supervision.
h Existing paragraph (b) would be redesignated as paragraph (c).
The Commission is proposing to add a new paragraph (b) to address the i
supervisory responsibilities of the licensee, the authorized' nuclear f
i pharmacist, and the physician authorized user who prepare unsealed byproduct material for medical use. Specifically, under the proposed paragraph, an authorized nuclear pharmacist or a physician authorized user would be able to permit individuals to prepare unsealed byproduct material for medical use, i
provided that the individuals are adequately supervised. This section i
describes the level of supervision that an authorized nuclear pharmacist or a f
i physician authorized user would be required,to provide to individuals who are preparing unsealed byproduct material for medical use under their supervision.
l Section 35.27 Visitina authorized user.
{
~
The Commission is proposing to delete this section which permits a visiting authorized user to. work for a period of 60 days each year without a
{
l
. license amendment.
Under proposed's 35.13(b), the concept of a visiting authorized user would no longer be necessary. Any individual who meets 30
.]
l 35.13(b)(1) through (b)(4) would be permitted to work in a licensee's facility either temporarily or permanently.
However, under proposed 6 35.14, the licensee would be required to provide a copy of the individual's board certification, the license, or the permit to the NRC.
i Section 35.49 Supolier for sealed sources or devices for medical use.
i The Commission is proposing to modify this section as follows:
The title of this section would be modified to indicate that this section would only apply to sealed sources or devices for medical use.
The Commission is proposing to delete the reference to il 32.72 and 32.73 in the proposed 5 35.49(a) because, under the proposed rule, the requirements applicable to unsealed byprowet material for medical use would be incorporated into the proposed il 35.100, 35.200, and 35.300.
Furthermore, the proposed rule would allow medical use licensees to prepare (including compound) radioactive drugs.
Therefore, limiting suppliers of l
radioactive drugs to manufacturers or commercial nuclear pharmacies would no longer be necessary. However, the requirements applicable to sealed sources l
or devices as specified in 6 32.74 would remain in the proposed 5 35.49(a) 1 In addition, the Commission is proposing to delete existing 6-35.49(b).
Under the proposed rule, all the requirements applicable to reagent kits would be deleted because the reagent kits do not-contain byproduct material.
Therefore, this paragraph would no longer be necessary.
The existing-1 6 35.49(c) would be redesignated as 5 35.49(b).
31 l
. ~ -
Section 35.50 Possession. use. calibration. and checks of dose calibrators.
I The Commission is proposing the following modifications to this section.
i (1) In paragraph (a), the phrase " photon-emitting" would be' inserted to clarify that this section is applicable only to photon-emitting radionuclides.
This modification would avoid confusion between this section and proposed' 6 35.52 pertaining to instruments to measure dosages of alpha-or beta-emitting radionuclides.
(2) The Commission is proposing to use the term " radionuclides"-instead of the term "radiopharmaceuticals." The new term is broader and would include radiolabeled biologics as well as radiopharmaceuticals.
(3) In paragraph (b)(3) regarding the linearity test of the dose calibrator, the lower limit for the test would be changed from 0.37 megabecquerel (10 microcuries) to 1.1 megabecquerel (30 microcuries).
This modification is necessary for consistency with the requirements of the Quality Management Program (6 35.32) and. proposed _ l 35.53 (c)(3).
(4) In paragraphs (e)(2) through (e)(4) regarding. records on the i
accuracy, linearity, and geometry tests of dose calibrators, the Commission is proposing to require the identity of the individual actually performing _these _
tests rather than the Radiation Safety Officer's (RS0) signature. This proposed change is necessary to identify the individual who' actually performed j
these tests.
Furthermore, this change would provide additional time for the 1
RSO to devote to other radiation safety. issues.
l l
32 i
3
1 Section 35.52 Possession. use. calibration. and checks of instrumentation to measure dosaaes of aloha-and beta-emittino radionuclides.
The Commission is proposing to require medical use licensees to possess j
.I and use instrumentation to measure alpha-or beta-emitting radionuclides.
New j
radiolabeled biologics are being developed which have potential benefits for diagnosis and treatment in medicine.
Some of these biologics may contain alpha-or beta-emitting radionuclides that do not emit photons of sufficient energy or frequency to be detected or quantified in a dose calibrator. Thus, this section is proposed so that medical use licensees would be able to j
determine that the correct dosages will be administered to patients or human research subjects.
The measurement requirements of this section would not apply to unit dosages obtained from a manufacturer or a commercial nuclear pharmacy for the following reasons:
(1) the instrumentation for measuring activity of alpha-l or beta-emitters is expensive and not commonly available in a medical use licensee's facility; (2) the frequency of using alpha-or beta-emitters for most medical use licensees is very low; and (3) the manufacturer or the.
commercial nuclear pharmacy would be required, pursuant to proposed l
1 32.72(c), to measure each dosage of-a radioactive drug prior to transfer l
for commercial distribution.
Section 35.53 ' Measurement of dosaaes of unsealed bvoroduct material for L
medical use.
l 33 l
l l
1 i
o J
y The Commission is proposing to modify this section as follows:
(1) In the title, the term "radiopharmaceutical dosages" would be l
replaced by the phrase " dosages of unsealed byproduct material for medical i
use." This is proposed to avoid the connotation that the Commission is regulating drug safety and efficacy. The word " unsealed" is proposed to l
emphasize that this section applies only to unsealed byproduct material for t
medical use. This section does not apply to sealed sources such as teletherapy or brachytherapy sources.
(2) Existing paragraphs (a) and (b) have been combined as proposed paragraph (a). However, the measurement requirements are the same.
(3) The new text of paragraph (b) would require medical use licensees to measure dosages of alpha-or beta-emitting radionuclides, except for unit-dosages obtained from a manufacturer or a commercial nuclear pharmacy.
Medical use licensees would be required.to measure dosages that will be administered to patients or human research subjects.
The measurement requirements of this section would not apply to unit dosages of alpha-or beta-emitting radionuclides because the manufacturer or the commercial nuclear pharmacy must measure the dosage before distributing it to a medical use licensee. Also, the proposed rule would allow a licensee to use the combination of several measurements and calculations to determine the dosage because it may not be possible to measure alpha-or beta-emitting radionuclides by a single measurement.
(4) In paragrap_h (c)(3), 0.37 megabecquerel (10 microcuries) would be changed to 1.1 megabecquerels (30 microcuries).
This modification is necessary for consistency.with the requirements of the Quality Management Program (1 35.32). Also, because the radiological risk associated with a -
34
1 j
)
dosage of 1.1 megabecquerels (30 microcuries) is small, it is unnecessary to l
require more than just recording that the dosage is less than 1.1 megabecquerels (30 microcuries),
j Section 35.100 Use of unsealed bvoroduct material for untake. dilution. and j
excretion.
I The current 6 35.100 requires medical use licensees to use only t
byproduct material in a radiopharmaceutical for uptake, dilution and excretion j
for which the FDA has accepted a " Notice of Claimed Investigational Exemption
~
for a New Drug" (IND) or approved a New Drug Application (NDA). The effect of this restriction is to prohibit a licensee from using other types of j
radioactive drugs such as those approved b: a Radioactive Drug Research Committee (RDRC), unless a license amendment is received authorizing their use.
i The Commission believes that these restrictions can be eased without compromising the level of protection of public health and safety against radiological hazards because of certain conditions which must be met (discussed below).
In addition, the Commission recognizes that physicians have the primary responsibility for the diagnosis and treatment.of their I
patients or human research subjects.
Commission regulations are predicated on the assumption that preperly trained and. adequately' informed physicians w'ill.
make decisions that are.in the best interest of their patients or human' research subjects.
Furthermore, the pharmacological aspects of radioactive
. drugs, including drug. safety and efficacy, are regulated by the FDA.
35 4
-e, m-m m
--w,
Detailed discussions of proposed changes are presented below.
The Commission is proposing to use the term " unsealed byproduct material" instead of the term "radiopharmaceutical" in this proposed section.
This is proposed to avoid the connotation that the Commission is regulating drug safety and efficacy. The word " unsealed" is proposed to emphasize that this section applies only to unsealed byproduct material for medical use and does not apply to sealed sources such as teletherapy or brachytherapy sources.
This proposed modification would provide medical use licensees with the maximum flexibility to use any byproduct material for medical use provided that the material is:
(1) obtained from a manufacturer or preparer licensed pursuant to 10 CFR 32.72; or (2) prepared by an authorized nuclear pharmacist, a physician authorized user who meets the training requirements specified in 5 35.920, or an individual under supervision of either, as specified in proposed 5 35.25.
In addition, the Commission is proposing to modify this section as follows:
(1) The phrase " unsealed byproduct material prepared for medical use" would be used.
This phrase includes "IND" and "NDA," as specified in the existing i 35.100, and other radioactive drugs containing byproduct material that are not specified in the existing 6 35.100.
(2) The supplier or preparer of unsealed byproduct material for medical use would be specified under this section. A licensee may obtain byproduct material from a manufacturer or a commercial nuclear pharmacy.
(3) This proposed section would allow licensees to use unsealed byproduct material to prepare (including compound) radioactive drugs by physician authorized users who meet i 35.920, authorized nuclear pharmacists, 36
or individuals under their supervision.
The NRC is using the phrase " prepare radioactive drugs" in a general sense to include:
(a) using radionuclide generators and nonradioactive reagent kits to produce radioactive drugs and (b) using byproduct material and other basic ingredients to compound radioactive drugs.
(4) This proposed section would require a physician authorized user who wants to prepare radioactive drugs to meet the requirements specified-in existing 9 35.920. Training and experience requirements specified in existing 19 35.910 and 35.930, although adequate to administer byproduct material, would not be sufficient for preparing radioactive drugs.
Similar training and experience requirements for authorized nuclear pharmacists are proposed in 6 35.980.
(5) This proposed section would also allow an individual under the supervision of a physician authorized user or an authorized nuclear pharmacist to use byproduct material to prepare (including compound) radioactive drugs. A l
Part 35 medical use licensee operating a nuclear pharmacy to prepare radioactive drugs for use within the licensee's facility would not be required to obtain a Part 32 license, unless the nuclear. pharmacy transfers radioactive l
drugs for commercial distribution. The proposed rule language in 9 35.25 i
would require the supervising physician authorized user or authorized nuclear pharmacist to instruct the individual on radiation safety principles and procedures and would require the' individual to follow the procedures.
i (6) The Commission recognizes that, in the course of patient care or in l
the conduct of research procedures, it is sometimes necessary to transfer a dosage of a radioactive drug, on a case-by-case basis, from one medical use licensee to another medical use licensee.
These case-specific transfers would I
37-
not be considered commercial transfers by the NRC and, therefore, would not require a Part 32 license.
Licensees should be aware that other than infrequent transfers may require a license for commercial transfer of byproduct material.
Section 35.200 Use of unsealed byproduct material for imaaina and localization studies.
Paragraph (a) of the current 9 35.200 restricts medical use licensees to use byproduct material in a radiopharmaceutical for which the FDA has accepted an IND or approved an NDA. The effect of this restriction is to prohibit a licensee from using other types of radioactive drugs such as those approved by a Radioactive Drug Research Committee (RDRC), unless a license amendment is received that authorizes such use.
Furthermore, paragraphs (b) and (c) of the current section require licensees to follow the manufacturer's instructions for eluting radionuclide generators and preparing reagent kits unless a departure is directed by a physician authorized user.
The Commission believes that these restrictions can be eased without compromising the level of protection of public health and safety against radiological hazards because of certain conditions which must be met (discussed below).
In addition, the Commission recognizes that physicians have the primary responsibility for the diagnosis and treatment of their patients or human research subjects and recognizes that the nuclear pharmacists have the primary responsibility for the preparation of radioactive drugs. Commission regulations are predicated on the assumption that properly trained and adequately informed physicians and pharmacists will make decisions 38 l
l
i
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f that are in the best interest of their patients or human research subjects.
Furthermore, the pharmacological aspects of radioactive drugs, including drug safety and efficacy, are regulated by the FDA.
Detailed di.scussions of proposed changes are presented below.
(1) The Commission is proposing to use the term " unsealed byproduct i
material" instead of the term "radiopharmaceutical" in this proposed section l
l to avoid the connotation that the Commission is regulating drug safety and 1
efficacy. Also, this phrase includes "IND" and "NDA," as specified in the existing i 35.200, and other radioactive drugs containing byproduct material that are not specified in the existing 9 35.200.
(2) This proposed modification would provide medical use licensees with the maximum flexibility to use any b;prooect material for medical use provided that the material is:
(a) obtained from a manufacturer or preparer licensed pursuant to 10 CFR 32.72 or (b) prepared by an authorized nuclear pharmacist, a physician authorized user who meets the training requirements specified in 5 35.920, or an individual under supervision of either, as specified in proposed 5 35.25.
(3) The supplier or preparer of unsealed byproduct material for medical i
use would be specified under this section.
A licensee may obtain byproduct material from a manufacturer or a commercial nuclear pharmacy.
(4) This proposed section would allow licensees to use unsealed byproduct material to prepare (including compound) radioactive drugs by physician authorized users who meet 9 35.920, authorized nuclear pharmacists, or individuals under their supervision. The NRC is using the phrase " prepare radioactive drugs" in a general sense to include:
(a) using radionuclide generators and nonradioactive reagent kits to produce radioactive drugs; and 39
(b) using byproduct material and other basic ingredients to compound radioactive drugs.
(5) This proposed section would also allow an individual under the supervision of a physician authorized user or an authorized nuclear pharmacist to use byproduct material to prepare (including compound) radioactive drugs.
The proposed rule language in s 35.25 would require the supervising physician authorized user or authorized nuclear pharmacist to instruct the individual on radiation safety principles and procedures and would require the individual to i
follow the procedures.
(6) The Commission recognizes that, in the course of patient care or in the conduct of research procedures, it is sometimes necessary to transfer a dosage of a radioactive drug, on a case-by-case basis, from one medical use licensee to another medical use licensee. These case-specific transfers would not be considered commercial transfers by the NRC and, therefore, would not require a Part 32 license.
9 Section 35.300 Use of unsealed byproduct material-for therapeutic administration.
i Paragraph (a) of the current 9 35.300 restricts medical use licensees I
to use byproduct material in a radiopharmaceutical for which the FDA has accepted an IND or approved an NDA. Also, this paragraph requires licensees; to comply with the package insert instructions regarding indications and method of administration unless a dep&rture is directed by a physician authorized user.
j i
40
.l i
While recognizing that therapeutic dosages-result in greater radiation exposure, the Commission believes that these restrictions can be eased without compromising the level of protection of public health and safety against I
radiological hazards because of certain conditions which must be met (discussed below).
In addition, the Commission recognizes that physicians I
have the primary responsibility for the diagnosis and treatment of their patients or human research subjects. Commission regulations are predicated on the assumption that properly trained and adequately informed physicians will l
make decisions that are in the best interest of their patients or human 1
research subjects.
Furthermore, the pharmacological aspects of radioactive.
drugs, including drug safety and efficacy, are regulated by the FDA.
Detailed discussions of proposed changes are presented below.
(1) The Commission is proposing to use.the term." unsealed byproduct
{
material" inste;1 of the term "radiopharmaceutical" in this proposed.section to avoid the connotation that the Commission is regulating drug safety and
)
efficacy. Also, this phrase includes "IND" and "NDA," as'specified in the existing 6 35.300, and other radioactive drugs containing byproduct material that are not specified in the existing i 35.300.
(2) This proposed modification would provide medical use licensees with the maximum flexibility to use any byproduct material for medical. use provided that the material is:
(a) obtained from a manufacturer or preparer licensed i
pursuant to 10 CFR 32.72 or (b) prepared by an authorized nuclear pharmacist, a physician authorized user who meets the training requirements specified in 5 35.920, or an individual under supervision of either, as specified in proposed 6 35.25.
.41
i e
(3)
The supplier or preparer of unsealed byproduct material for medical l
use would be specified under this section. A licensee may obtain byproduct material from a manufacturer or a commercial nuclear pharmacy.
(4) This proposed section would allow licensees to use unsealed byproduct material to prepare (including compound) radioactive drugs by l
physician authorized users who meet-6 35.920, authorized nuclear pharmacists, j
or individuals under their supervision.
(5)
This proposed section would also allow an individual under the supervision of a physician authorized user or an authorized nuclear pharmacist i
i to use byproduct material to prepare (including compound) radioactive drugs.
i The proposed rule language in 6 35.25 would require the supervising physician authorized user or authorized nuclear pharmacist to instruct the individual on j
radiation safety principles and procedures and would require the individual to -
j follow the procedures.
(6) The Commission recognizes that, in the course of patient care or in l
the conduct of research procedures, it is sometimes necessary to transfer a dosage of a radioactive drug, on a case-by-case basis, from one medical use l
1 licensee to another medical use licensee. These case-specific transfers would-not be considered commercial transfers by the NRC and, therefore, would not require a Part 32 license.
l Section 35.900 Radiation Safety Officer.
The Commission-is proposing to modify this section to recognize.the certification in nuclear medicine by the Royal College of Physicians and
{
42 i
i Surgeons of Canada and in radiation oncology physics by the American Board of Medical Physics.
Section 35.910 Trainina for uptake. dilution. and excretion studies.
The Commission is proposing, as recommended by the ACMUI, to modify this section to recognize the certification in nuclear medicine by the Royal College of Physicians and Surgeons of Canada.
l Section 35.920 Trainino for imaaina and localization studies.
The Commission is proposing, as recommended by the ACMUI, to modify this i
section to recognize the certification in nuclear medicine by the Royal College of Physicians and Surgeons of Canada.
Section 35.930 Trainina for therapeutic use of unsealed byproduct material.
The Commission is proposing to amend 5 35.930(a)(2) to recognize the
]
certification in radiation oncology by the American Board of Radiology (ABR).
4 In 1987, the ABR renamed " therapeutic radiology" as " radiation oncology" but the criteria for certification remain the same. Therefore, it is necessary to recognize both certifications.
i l
l 43 l
Section 35.940 Trainina for use of brachytheraov sources.
The Commission is proposing to amend 9 35.940(a)(1) to recognize the certification in radiation oncology by the American Board of Radiology (ABR).
Section 35.950 Trainina for use of sealed sources for diaanosis, i
l The Commission is proposing to amend 6 35.950(a)(1) to recognize the l
certification in radiation oncology by the American Board of Radiology (ABR) and the certification in nuclear medicine by the Royal College of Physicians and Surgeons of Canada.
Section 35.960 Trainino for teletheraov.
The Commission is proposing to amend 5 35.960(a)(1) to recognize the certification in radiation oncology by the American Board of Radiology (ABR).
Section 35.961 Trainina for teletheraov chysicist.
The Commission is proposing to modify this section to recognize the certification in radiation oncology physics by the American Board of Medical Physics.
44
Section 35.972 Recentness of trainina.
j Existing 9 35.972 required that an individual's training must have been j
acquired within the last 5 years.
The Board of Pharmaceutical Specialties (BPS) recertifies board certified nuclear pharmacists (BCNP) every 7 years.
Based on BPS's 11 years experience with recertification, the Commission is l
proposing to replace 5 years with 7 years. This action is necessary to t
achieve consistency for recentness of training requirements among authorized I
users, Radiation Safety Officers, teletherapy physicists, and authorized nuclear pharmacists. The Commission is requesting public comment on which period (either 5 or 7 years) is more appropriate and the basis for any recommendation.
Section 35.980 Trainina for authorized nuclear charmacist.
The Commission is proposing to add a new section that would contain specific training requirements for an authorized nuclear pharmacist. This action is necessary because an authorized nuclear pharmacist may be responsible for handling, preparing, and distributing radioactive drugs to multiple medical institutions. Thus, authorized nuclear pharmacists potentially impact the radiological safety of patients or human research subjects at many medical institutions. The effect of these training requirements will provide sufficient assurance that individuals satisfying these training criteria will safely prepare and distribute radioactive drugs.
In this section, the Commission is proposing two methods for an individual to qualify as an authorized nuclear pharmacist:
45 l
4 (1)
In paragraph (a), the Commission is proposing to recognize certification by the Board of Pharmaceutical Specialties as a nuclear pharmacist as satisfying the training requirements.
l (2)
In paragraph (b), in lieu of board certification, an alternative method to qualify for an authorized nuclear pharmacist is proposed. A candidate would be_ required to:
(i) complete 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> in a structured i
educational program consisting of both didactic training and supervised experience in a nuclear pharmacy, and (ii) obtain a written certification from a preceptor that the candidate has achieved a level of competency sufficient to independently operate a nuclear pharmacy.
Implementation Plan and Agreement State Compatibility i
The effective date of this amendment would be 6 months after the i
publication of the final amendment in the Federal Register.
On July 15 and 16, 1992, the NRC held a workshop with representatives of I
i 23 Agreement States to discuss the. draft rule language for the proposed j
rulemaking. The Agreement State participants expressed a clear consensus that this proposed rulemaking be either not an item of compatibility or the lowest level of compatibility possible.
However, because this-amendment has safety significance for Agreement State licensees as well as NRC licensees, this proposed amendment would be an item of compatibility for the Agreement States.
All definitions contained in
-s 9 30.4 and 35.2 would be Division 1 items of compatibility.
The definitions contained in this rulemaking must be the same for all NRC and Agreement State licensees so that consistency will be maintained.
46 emM+r
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Additionally, the Commission believes that il 32.72,.35.6,35.22(b)(2),
l 35.25, 35.50, 35.52, 35.53, 35.920, 35.972 and 35.980 should be Division 2 P
items of compatibility, because these requirements are necessary to ensure adequate protection of the public health and safety. For example, 66 35.920 and 35.980 provide the radiation safety training and experience criteria for authorized users and authorized nuclear pharmacists that are important f
prerequisites for ensuring that byproduct material is handled safely. -_ I t should be noted that changing i 35.920 to a Division 2 item of compatibility l
would impact those authorized users who want to compound radioactive drugs as well as those authorized users who only want to perform imaging procedures currently allowed under 6 35.200. The Agreement States would be allowed to i
i establish requirements that are more stringent than NRC's requirements, but not less stringent.
It would be appropriate for Agreement States to adopt the remaining sections of Part 35 in this proposed rulemaking, but it is not necessary to require any degree of uniformity between NRC and the States.
Therefore, a Division 3 item of compatibility would be appropriate for such sections.
The Commission is currently reevaluating its practices concerning the implementation of the provision in the Atomic Energy Act which provides that-the Agreement States' regulatory programs are to be compatible with NRC's.
This reevaluation will include early and significant involvement of the Agreement States.
At the conclusion'of this effort, the Commission will implement generic guidance on the application of compatibility.
For comparison, the existing compatibility levels are as follows:
definitions in i 30.4 are Division 1 items of. compatibility; E 32.72 is a Division 2 item of compatibility; the definitions associated with the quality i
47
management rule and misadministrations in 6 35.2 are Division 1 items of compatibility; ll 35.32 and 35.33 are Division 2 items of compatibility; I 35.8 is a Division 4 item of compatibility; and all other sections of Part 35 are Division 3 items of compatibility.
The NRC expects Agreement States to adopt rules required to maintain compatibility within three years after NRC's rules become effective.
Some Agreement States, faced with administrative and resource constraints, may find the three year goal difficult to attain and may prefer that NRC extend flexibility in such cases to allow the States to implement the requirements through license conditions.
The NRC requests public comment on permitting Agreement States flexibility in this regard, and if permitted, under what conditions.
Finding of No Significant Environmental Impact: Availability r
The Commission has determined under the National Environmental Policy Act of 1969, as amended, and the Commission's regulations in Subpart A of 10 CFR Part 51, that the proposed amendments, if adopted, would not be a major Federal action significantly affecting the quality of the human environment, and therefore an environmental impact statement is not required. The proposed amendments would provide greater flexibility for physician authorized users to l
use byproduct material in the practice of medicine. The proposed amendments would also incorporate into the regulations the concept of authorized nuclear pharmacists to permit properly qualified pharmacists to prepare radioactive drugs containing byproduct material in the practice of pharmacy.
48 t
I The proposed amendments would allow physician authorized users greater discretion to prepare and use radioactive drugs containing byproduct material.
The proposed amendments would also allow authorized nuclear pharmacists greater discretion to prepare radioactive drugs containing byproduct material.
It is expected that there will be no increase in radiation exposure to the public or to the environment beyond the exposures currently resulting from delivering the byproduct material or radiation from byproduct material to patients or human research subjects.
The draft environmental assessment and f
finding of no significant impact on which this determination is based is i
available for inspection' at the NRC Public Document Room, 2120 L Street NW.
(Lower Level), Washington, DC.
Single copies of the draft c.nvironmental assessment and the finding of no significant impact are available from l
l l
Samuel Z. Jones or Anthony N. Tse (see FOR FURTHER INFORMATION CONTACT l
heading).
l Paperwork Reduction Act Statement.
This proposed rule amends information collection requirements that are subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq).
This rule has been submitted to the Office of Management and Budget for review and i
approval of the paperwork requirements.
The reduction in public burden for this collection of information is estimated to be a savings of 420 hours0.00486 days <br />0.117 hours <br />6.944444e-4 weeks <br />1.5981e-4 months <br /> per year for 300 NRC licensees, or an l
average 1.4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br /> per year per licensee, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.
Send l
49
comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to the Information and Records Management Branch (MNBB-7714), U.S. Nuclear Regulatory Commission, Washington, DC 20555, and to the Desk Officer, Office of l
Information and Regulatory Affairs, NE08-3019, (3150-0001, -0010, and -0120),
Office of Management and Budget, Washington, DC 20503.
Regulatory Analysis The Commission has prepared a draft regulatory analysis on this proposed regulation. The analysis examines the benefits and impacts considered by the Commission.
The draft regulatory analysis is available for inspection at the NRC Public Document Room at 2120 L Street NW. (Lower Level), Washington, DC.
Single copies of the draft analysis are available from Samuel Z. Jones or Anthony N. Tse (see FOR FURTHER INFORMATION CONTACT heading).
The Commission requests public comments on the draft regulatory analysis.
Comments on the draft regulatory analysis may be submitted to the NRC as indicated under the ADDRESSES heading.
4 Regulatory Flexibility Certification As required by the Regulatory Flexibility Act of 1980, 5 U.S.C. 605(b),
the Commission certifies that, if adopted, this proposed rule would not have a significant economic impact on a substantial number of small entities.
This proposed rule would affect medical use licensees including some private practice physicians.
Some of these licensees would be considered small 50
entities under the NRC's size standards (56 FR 56672; November 6, 1991).
The proposed amendments would provide greater discretion for physician authorized I
users to use byproduct material in the practice of medicine. The proposed amendments would also incorporate into the regulations the concept of I
authorized nuclear pharmacists to allow properly qualified pharmacists greater
)
discretion to prepare (including compound) radioactive drugs containing -
byproduct material for medical use. This rule:::aking, if adopted, would reduce regulatory burdens on medical use licensees, including small entities.
Any small entity subject to this regulation who determines that, because of its size, it is likely to bear a disproportionate adverse economic impact j
should notify the Commission by a letter that indicates the following:
(a) The licensee's. size.and how the proposed regulation would result in a significant economic burden or whether the resources necessary to implement this amendment could be more effectively used in other ways to optimize the safety of patients or human research subjects, as compared to the economic burden on a larger licensee; (b) How the proposed regulation could be modified to take into account the licensee's differing needs or capabilities; (c) The benefits that would accrue, or the detriments.that would be avoided, if the proposed regulation were modified as suggested by the licensee; (d) How the proposed regulation, as modified, could more closely equalize the impact' of NRC regulations or create more equal access to.the benefits of Federal programs as opposed to providing special advantages to any i
individual or group; 1
51
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(e) How the proposed regulation, as modified, would.still: adequately protect the public health and safety.
I Backfit. Analysis.
The Commission has determined that the backfit rule,-10 CFR 50.109, do'es l
i not apply to this proposed amendment because this amendment does not involve i
1 any provisions which would impose backfits as defined in'10 CFR 50.109(a)(1).
l Therefore, a backfit analysis is' not required for this proposed amendment.
List'of Subjects-
- i 10 CFR Part 30 i
Byproduct material, Criminal penalty, Government contracts, Intergovernmental relations, Isotopes, Nuclear materials, Radiation l
protection, Reporting and recordkeeping. requirements.
. i i
4 10 CFR Part 32 Byproduct material, Labeling, Nuclear materials, Criminal Penalty, l
i Radiation protection, Reporting and'recordkeeping requirements.
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52 i
i 4
1 10 CFR Part 35 Byproduct material, Criminal penalty, Drugs, Health facilities, Health professions, Incorporation by reference, Medical devices, Nuclear materials, Occupational safety and health, Radiation protection, Reporting and recordkeeping requirements.
For the. reasons set out in the preamble and under the authority of. the i
Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974,.
as amended, and 5 U.S.C. 553, the Commission is proposing to adopt the following amendments to 10 CFR Parts 30, 32..and 35.
PART 30 - RULES OF GENERAL APPLICABILITY TO DOMESTIC LICENSING 0F BYPRODUCT i
MATERIAL i
1.
The authority citation for Part 30 continues to read as follows:
AUTHORITY: Secs. 81, 82, 161, 182, 183, 186,.68 Stat.-935, 948, 953, 954, 955, as amended, sec. 234, 83 Stat. 444, as amended (42 U.S.C. 2111, 2112, 2201, 2232, 2233, 2236, 2282); secs. 201, as amended, 202, 206, 88 Stat.
1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846).
Section 30.7 also issued under Pub. L.95-601, sec. 10, 92 Stat. 2951 (42 U.S.C. 5851).- Section 30.34(b) also issued under sec.184, 68 Stat. 954, as amended (42 U.S.C. 2234). Section'30.61 also issued under sec.187, 68 Stat. 955 (42 U.S.C. 2237).
53 n
w-a
1 2.
In 5 30.4, the definition of medical use is revised to read as follows:
9 30.4 Definitions.
- l Medical use means the intentional internal or external administration of byproduct material or the radiation therefrom to patients or human research' I
subjects under the supervision of an authorized user.
i i
3.
In 6 30.8, paragraphs (b) and (c) are revised to read as follows:
1 l 30.8 Information collection requirements: OMB' approval.-
i (b) The approved information collection requirements contained in this l
part appear in El 30.9, 30.11, 30.15, 30.19, 30.20, 3'.32, 30.34, 30.35, 0
30.36, 30.37, 30.38, 30.41, 30.50, 30.51, 30.55, and Appendix A.
j (c) This part contains information' collection requirements ;
jdition to those approved under the control number specified in paragraph (a).of this section. These information collection requirements and the control numbers I
under which they are approved are as follows:
(1)
In il 30.32, 30.37, and 30.38, NRC Form 313 is approved under i
control number 3150-0120.
(2)
In 6 30.36, NRC Form 314,is approved under. control number 3150-0028.
I 54 i
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l 30.34 [ Amended]
4.
Section 30.34 is amended by removing paragraph (i) in its entirety.
PART 32 - SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL 5.
The authority citation for Part 32 continues to read as'follows:
AUTHORITY: Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954, as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841).
6.
In 1 32.8, paragraphs (b) and (c) are revised to read as follows:
i 6 32.8 Information collection rer,uirements: OMB approval.
s (b) The approved information collection requirements contained in this part appear in s 9 32.12, 32.14, 32.15, 32.16, 32.17, 32.18, 32.19, 32.20, 32.22, 32.25, 32.26, 32.29, 32.51, 32.51a, 32.52, 32.53, 32.54, 32.56, 32.57, 32.58, 32.61, 32.70,.32.71, 32.72, and 32.74.
(c) This part contains information collection requirements in addition to those approved under the control number'specified in paragraph (a) oof this section. These information collection requirements and the control numbers under which they are approved are as follows:
(1)
In 132.11, NRC Form 313 is approved under control number 3150-0120.
55
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7.
Section 32.72 is revised to read as follows:
j J
l 1 32.72 Manufacture, preparation, or transfer for commercial distribution of l
radioactive drugs containing byproduct material for medical' use under Part 35.
(a) An application for a specific license to manufacture, prepare, or transfer for commercial distribution radioactive drugs containing byproduct 1
material for use by persons authorized pursuant to Part 35 of this chapter l-will be approved if:
(1) The applicant satisfies the general requirements specified in 10 CFR 30.33; (2) The applicant submits evidence that the. applicant is at least one of the following:
(1)
Registered or licensed with the U.S. Food and Drug Administration (FDA) as a drug manufacturer; (ii)
Registered or licensed with a state agency 'as a drug manufacturer; (iii)
'icensed as a pharmacy by a State Board of Pharmacy; or (iv) Operating as a nuclear pharmacy within a Federal medical institution.
(3) The applicant submits information on the radionuclide; the chemical and physical form; the maximum activity per vial, syringe, generator, or other container of the radioactive drug; and.the shielding provided by the packaging to show it is appropriate for the safe handling and storage of the radioactive drugs by medical use licensees; and (4) A label is affixed to each container of a radioactive drug to be transferred for commercial distribution. The label'must include the name of the radioactive drug or its abbreviation, quantity of radioactivity, and date 56
and time of assay.
In addition, the label for the syringe 'or syringe I
radiation shield must also contain the clinical procedure to be performed or the patient's or the human research subject's name.
Furthermore, the label, or the leaflet or brochure that accompanies _ the radioactive drug must contain a statement that the U.S. Nuclear Regulatory Commission has approved f
distribution of the byproduct material to persons licensed to use byproduct material pursuant to 10 CFR 35.100, 35.200, or 35.300, as appropriate, and to l
persons who hold an equivalent license issued by an Agreement State.
The label, or the leaflet or brochure must also note that other regulatory approvals may be required.
NRC's labeling requirements are independent of requirements of the U.S. Food and Drug Administration (FDA).
(b)(1) A licensee described by paragraph (a)(2)(iii) or (iv) of this section may prepare radioactive drugs for medical use, as defined in 10 CFR 35.2, provided that the: radioactive drug.is prepared by.either an authorized nuclear pharmacist, as defined in 10 CFR 35.2, or an individual under the supervision of an authorized nuclear pharmacist as specified in 10 CFR 35.25.
(2)
In addition, for purposes of this section, an authorized nuclear pharmacist is a pharmacist who is currently licensed or registered by a state to practice pharmacy and designated, as of the effective date of the final rule, as an " authorized user" on a nuclear pharmacy license issued by the Commission under this part.
(3) A licensee shall provide to the Commission a copy of the individual's board certification, the license, or the permit, and the state pharmacy licensure or registration, respectively, for each individual within 57
. 1 t
t 30 days of the date that the licensee permits, pursuant to this section, the j
individual to work as an authorized nuclear pharmacist.
l (c) A licensee shall possess and use instrumentation to measure the l
4 radioactivity of radioactive drugs. The-licensee shall have _ procedures for i
use of the instrumentation. The licensee shall measure, by direct measurement
- t or by combination of measureme'ts and calculations, the amount of j
radioactivity in dosages of alpha., beta, or photon-emitting. radioactive drugs prior to transfer for commercial distribution.
In addition, the-licensee shall:
(1) Perform tests before initial use, periodically, and following repair, on each instrument for accuracy, linearity, and geometry dependence, j
as appropriate for the use of the instrument; and make adjustments when l
t necessary; and l
(2) Check each instrument for constancy and proper operation at the beginning of each day of use.
f (d) Nothing in this section relieves the licensee from complying with l
applicable FDA, other Federal, and State requirements governing' radioactive l
- drugs,
! 32.73 [ Removed]
8.
Section 32.73 is removed.
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PART 35 - MEDICAL USE OF BYPRODUCT MATERIAL 1
f.
9.
The authority citation for Part 35 continues to read as f
follows:
AUTHORITY: Secs. 81, 161, 182, 183, 68 Stat. 935,.948, 953,.954, as amended (42 U.S.C. 2111, 2201, 2232,-2233); sec. 201, 88 Stat. 1242, as i
amended (42 U.S.C. 5841).
10.
In 5 35.2, the definitions of authorized nuclear charmacist' and charmacist are added and the definitions of authorized user, g_ dical use,:
1 para. graphs (1)(i), (2)(i), (3)(i), (4)(i), (5)(i), (6)(i),- and (6)(ii) of the 4
definition of misadministration; and the introductory sentence of-the definition of written directive are revised to read as follows:
]
l 35.2 Definitions.
{
a Authorized nuclear charmacist means a pharmacist.who is:
(1) Currently board certified as a nuclear pharmacist by the Board of 1
Pharmaceutical Specialties; (2) Identified as an authorized nuclear pharmacist on a Commission or Agreement State license that authorizes the use of byproduct material-in the practice of nuclear pnarmacy;. or (3) Identified as an. authorized ncclear pharmacist on a permit issued by a Commission or Agreement State specific licensee of broad scope that is authorized to pernit the use of byproduct material ?in.the practice of nuclear.
pharmacy.
59 i
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Authorized user means a physician, dentist, or podiatrist who is:
(1) Board certified by at least one of the boards listed in Paragraph (a) of ss 35.910, 35.920, 35.930, 35.940, 35.950, or 35.960; (2) Identified as an authorized user on a Commission or Agreement State license that authorizes the medical use of byproduct material; or (3) Identified as an authorized user on a permit issued by a Commission or Agreement State specific licensee of broad scope that is authorized to permit the medical use of byproduct material.
Medical use means the intentional internal or external administration of byproduct material or the radiation therefrom to patients or human research subjects under the supervision of an authorized user.
Misadministration means the administration of:
(1)
(i)
Involving the wrong patient or human research subject, or wrong radiopharmaceutical; or (2)
(i)
Involving the wrong patient or human research subject, wrong radiopharmaceutical, or wrong route of administr..cion; or (3)
(i)
Involving the wrong patient or human research subject, or wrong treatment site; or (4)
(i)
Involving the wrong patient or human research subject, wrong mode of treatment, or wrong treatment site; 60
P l
(5)
(i)
Involving the wrong patient or human research subject, wrong radioisotope, or wrong treatment site (excluding, for permanent implants, seeds that were implanted in the correct site but migrated outside the
[
treatment site);
(6) i (i)
Involving the wrong patient or human research subject, wrong radiopharmaceutical, wrong route of administration, or when the administered dosage differs from the prescribed dosage; and (ii) When the dose to the patient or human research subject exceeds 5 rems effective dose equivalent or 50 rems dose equivalent to any individual organ.
Pharmacist means an individual licensed by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to practice pharmacy.
Written directive means an order in writing for a specific patient or human research subject, dated and signed by an authorized user prior to the administration of a radiopharmaceutical or radiation, except as specified in paragraph (6) of this definition, containing the following information:
61
11.
Section 35.6 is added to read as follows:
f 1 35.6 Provisions for research involving human subjects.
A licensee may conduct research involving human subjects using byproduct material provided that the research is conducted, funded, supported, or regulated by another Federal Agency which has implemented the Federal Policy for the Protection of Human Subjects.
Otherwise, a licensee shall apply for and receive approval of a specific amendment to its NRC license before conducting such research.
Both types of licensees shall, at a minimum, obtain informed consent from the human subjects and obtain prior review and approval i
of the research activities by an " Institutional Review Board."
12.
Section 35.7 is added to read as follows:
6 35.7 FDA, other Federal, and State requirements.
Nothing in this part relieves the licensee from complying with applicable FDA, other Federal, and State requirements governing radioactive drugs or devices.
i 13.
In 5 35.8, paragraph (b) is revised to read as follows:
(b)
The approved information collection requirements contained in this part appear in il 35.6, 35.12, 35.13, 35.14, 35.21, 35.22, 35.23, 35.29, 35.31, 35.50, 35.51, 35.52, 35.53, 35.59, 35.60, 35.61, 35.70, 35.80, 35.92, 35.204, 35.205, 35.310, 35.315, 35.404, 35.406, 35.410, 35.415, 35.606, 62
i 35.615, 35.630, 35.632, 35.634, 35.636, 35.641, 35.643, 35.645, 35.647, and 35.980.
14.
In 6 35.11, paragraph (a) is revised and paragraph (c) is added to read as follows:
6 35.11 License required.
l (a) A person shall not manufacture, produce, acquire, receive, possess, i
use, or transfer byprodur.t material for medical use except in accordance with a specific license issued by the Commission or an Agreement State, or as l
allowed in paragraphs (b) or (c) of this section.
(c) An individual may prepare unsealed byproduct material for medical use in accordance with the regulations in this chapter under the supervision of an authorized nuclear pharmacist or authorized user as provided in 9 35.25, unless prohibited by license condition.
15.
In 6 35.12, paragraph (e) is added to read as follows:
9 35.12 Application for license, amendment, or renewal.
(e) An applicant that satisfies the requirements specified in 10 CFR 33.13 may apply for a Type A specific license of broad scope.
63
16.
In i 35.13, paragraph (b) is revised to read as follows:
5 35.13 License amendments (b) Before it permits anyone to work as an authorized user or authorized nuclear pharmacist under the license, except an individual who is:
(1) An authorized user certified by the organizations specified in paragraph (a) of El 35.910, 35.920, 35.930, 35.940, 35.950, or 35.960; (2) An authorized nuclear pharmacist-certified by the organization specified in paragraph-(a) of 5 35.980; (3) Identified as an authorized user. or an authorized nuclear pharmacist.
on a Commission or Agreement State license that authorizes the use of byproduct material in medical use or.in the practice of nuclear pharmacy,-
respectively; or (4) Identified as an authorized user or an authorized nuclear pharmacist on a permit issued by a Commission or Agreement State specific licensee of broad scope that is authorized to permit the use of byproduct material in medical use or in the practice of nuclear pharmacy, respectively.
- 17. Section 35.14 is revised to read as follows:
6 35.14 Notifications.
~
(a) A licensee shall provide to-the Commission a ' copy of. the board certification, the license, or the permit for each individual within 30 days 64-
of the date that the licensee permits the individual to work as an authorized user or an authorized nuclear pharmacist pursuant to 9 35.13(b)(1) through (b)(4).
(b) A licensee shall notify the Commission by letter within 30 days when:
(1) An authorized user, an authorized nuclear pharmacist, Radiation Safety Officer, or teletherapy physicist permanently discontinues performance of duties under the license or has a name change; or (2) The licensee's mailing address changes.
(c) The licensee shall mail the documents required in this section to the appropriate address identified in 5 30.6 of this chapter.
18.
Section 35.15 is added to read as follows:
6 35.15 Exemptions regarding Type A specific licenses of broad scope.
A licensee possessing a Type A specific license of broad scope for medical use is exempt from the following:
(a) The provisions of 6 35.13(b);
(b) The provisions cf 9 35.13(e) regarding additions to or changes in the areas of use only at the addresses specified in the license; (c) The provisions of 9 35.14(a); and (d) The provisions of 6 35.14(b)(1) for an authorized user or an authorized nuclear pharmacist.
65
1 19.
In 5 35.22, paragraph (b)(2) is revised to read as follows:
6 35.22 Radiation Safety Committee.
l l
(b)
(2)(1) Review, on the basis of safety and with regard to the training and experience standards in Subpart J of this part, and approve or disapprove any individual who is to be listed as an authorized user, an authorized nuclear pharmacist, the Radiation Safety Officer, or a teletherapy physicist before submitting a license application or request for amendment or renewal; or (ii) Review, pursuant to 6 35.13(b)(1) through (b)(4), on the basis of the board certification, the license, or the permit identifying an individual, and approve or disapprove any individual prior to allowing that individual to work as an authorized user or authorized nuclear pharmacist; 20.
In 9 35.25, paragraph (b) is redesignated as paragraph (c) and a new paragraph (b) is added to read as follows.
1 35.25 Supervision.
(b) A licensee that permits the preparation of byproduct material for medical use by an individual under the supervision of an authorized nuclear pharmacist or physician who is an authorized user, as allowed by 9 35.ll(c),
66
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shall require the supervising authorized nuclear pharmacist or physician who is an authorized user to:
(1)
Instruct the supervised individual in the preparation of byproduct l
material for medical use and the principles of and procedures for radiation l
safety and in the licensee's written quality management program, as appropriate to that individual's use of byproduct material; (2) Require the supervised individual to follow the instructions given pursuant to paragraph (b)(1) of this section and to comply with the regulations of this chapter and license conditions; and (3)
Periodically review the work of the supervised individual as it pertains to preparing byproduct material for medical use and the records kept to reflect that work.
5 35.27 [ Removed]
21.
Section 35.27 is removed.
22.
In s 35.32, paragraphs (a)(2) and (b)(1)(i) are revised to read as follows:
6 35.32 Quality management program.
(a)
(2) That, prior to each administration, the patient's or human research subject's identity is verified by more than one method as the individual named in the written directive; 67 l
h l
l l
I-i i
1 l.
(b) j (1)
(i)
A_ representative sample of-patient and human research subject administrations, i
23.
In 6 35.33, paragraphs (a)(2), (a)(3), (a)(4), (b), and (c) are
-l revised to read as follows:
l l
q l 35.33 Notifications, reports, and records of misadministrations.
1 (a)
(2) The licensee shall submit a written report 'to the appropriate' NRC l
Regional Office listed in 10 CFR 30.6 within 15-days after discovery of the j
misadministration. The written report must include the licensee's'name; the 1
i prescribing physician's name; a brief description of the event; why the event-l occurred; the effect on the patient or-the human research subject; what i
improvements are needed to prevent recurrence;_ actions taken to prevent recurrence; whether the licensee notified the patient'or the human.research subject (or either individual's responsible relative or _ guardian), and if not,.
'l why not, and if the patient or the human research. subject (or either j
individual's responsible relative or guardian) was notified, what information was provided to that individual-. The report must not include the patient's or L
the human research subject's name or other,information that could le'ad to
-i identification of the patient or the human research subject.
1 i
(3).The licensee shall notify both the referring physician and the i
patient or the human research subject (or the patient's or the human research l
68-i l
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p
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t l
subject's responsible relative or guardian), of the misadministration no later i
l than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after its discovery, unless the referring physician personally
)
l informs the licensee either that he will inform the patient or the human research subject (or either individual's responsible relative or guardian) or l
that, based on medical judgment, telling the patient or the human research subject (or either individual's responsible relative or guardian) would be harmful to the patient or the human research subject. The licensee is not required to notify the patient or the human research subject (or either individual's responsible relative or g'uardian) without first consulting the l
referring physician.
If the referring physician or the patient or the human research subject (or 'the patient's or.the human research subject's responsible l
l relative or guardian) cannot be reached within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, the licensee shall notify the patient or the human research subject (or either individual's l
l responsible relative or guardian) as soon as possible thereafter.
The 1
li ensee may not delay any appropriate medical care for the patient or the i
huinan research subject, including any necessary remedial care as a result of the misadministration, because of any delay in notification.
(4) If the patient or.the human research subject (or either individual's l
responsible relative or guardian) was notified, the licensee shall also furnish, within 15 days after discovery of the misadministration, a written report to the patient or the human research subject _(or either individual's responsible relative or guardian) by sending either:
(i) A copy of the report that was':ubmitted to the NRC; or (ii) A brief description of both the event and the consequences as they may affect the patient or the human research subject, provided a statement is
-69
)
i included that the report submitted to the NRC can be obtained from the licensee.
i (b) Each licensee shall retain a record of each misadministration for l
five years. The record must. contain the names of all. individuals involved l
(including the prescribing physician, allied health personnel, the patient or the human research subject, and the patient's or human research subject's referring physician), the patient's or the human research subject's social security number or identification number if one has been assigned, a brief i
description of the misadministration, whylit occurred, the effect on the i
patient or the human research subject, what improvements are needed to prevent recurrence, and the. actions taken to prevent recurrence.
(c) Aside from the notification requirement, nothing in this section i
affects any rights or duties of licensees and physicians in relation to each l
other, patients or human research subjects (or either individual's responsible i
relative or guardian).
f
- 24. Section 35.49 is revised to read as follows:
i i
l 35.49 Suppliers for sealed sources or devices for medical use.
I A licensee may use for medical use only-l (a) - Sealed sources or devices manufactured,. labeled, packaged,- and distributed in accordance with a license issued pursuant-to 10 CFR Part 30'and i
32.74 or the equivalent regulations of an Agreement-State; or
}
(b) Teletherapy sources manufactured and distributed in accordance.with i
i a license issued pursuant to 10 CFR Part 30 or the equivalent regulations of-l t
an Agreement State, j
70
's
25.
In 5 35.50, paragraphs (a), (b)(3), and (e)(2) through (e)(4) are -
i revised to read as follows:
l 5 35.50 Possession, use, calibration, and check of dose calibrators.
l (a) A licensee shall possess and use a dose calibrator to measure the activity of dosages of photon-emitting radionuclides prior to administration to each patient or human research subject.
(b)
(3) Test each dose calibrator for linearity upon installation and at least quarterly thereafter over the rang'e of its use between the highest dosage that will be administered to a patient or human research subject and l
I 1.1 megabecquerels (30 microcuries); and (e)
(2)
For paragraph (b)(2) of this section, the model and serial number of the dose calibrator, the model and serial number of each source used, the identity of the radionuclide contained in the source and its activity, the date of the test, the results of the' test, and the identity of the individual performing the test.
j (3) For paragraph (b)(3) of this section,.the model and serial number of the dose calibrator, the calculated activities, the measured activities, i
the date of the test, and the identity. of the individual performing the test.
l (4)
For paragraph (b)(4) of this section, the model-and serial number of the dose calibrator. tne configuration of the source measured, the activity measured for each volume-measured, the date of the test, and the identity of-th'e ind' W al performing the test.
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- 26. Section 35.52 is added to read as follows:
s 35.52 Possession, use, calibration, and check of instruments to measure dosages of alpha-or beta-emitting radionuclides.
(a) This section does not apply to unit dosages of alpha-or beta-emitting radionuclides that are obtained from a manufacturer or preparer licensed pursuant to 10 CFR 32.72 or equivalent Agreement State requirements.
I (b)
For other than unit dosages obtained pursuant to paragraph (a) of this section, 4 licensee shall possess and use instrumentation to measure the radioactivity of alpha-or beta-emitting radionuclides.
The licensee shall have procedures for use of the instrumentation.
The licensee shall measure, by direct measurement or by combination of measurements and calculations, the amount of radioactivity in dosages of alpha-or beta-emitting radionuclides prior to administration to each patient or human research subject.
In additior, the licensee shall:
(1) Perform tests before initial use, periodically, and following repair, on each instrument for accuracy, linearity, and geometry dependence, as appropriate for the use of the instrument; and make adjustments when necessary; and l
l (2) Check each instrument for constancy and proper operation at the beginning of each day of use.
i l
27.
In 6 35.53, the section heading and paragraphs (a), (b), (c)(2),
and (c)(3) are revised as follows:
}
72 i
l
i 9 35.53 Measurement of dosages of unsealed byproduct material for medical use.
(a) Measure the activity of each dosage of a photon-emitting radionuclide prior to medical use.
(b) Measure, by direct measurement or by combination of measurements t
and calculations, the activity of each dosage of an alpha-or beta-emitting l
radionuclide prior to medical use, except for unit dosages obtained from a manufacturer or preparer licensed pursuant to 10 CFR 32.72 or equivalent l
Agreement State requirements; i
(c)
(2)
Patient's or human research subject's name, and identification l
number if one has been assigned; (3)
Prescribed dosage and activity of the dosage at the time of measurement, or a notation that the total activity is less than 1.1 megabecquerels (30 microcuries);
28.
In 9 35.60, paragraphs (b) and (c) are revised to read as follows:
6 35.60 Syringe shields and labels.
(b) lo identify its contents, a licensee shall conspicuously label each syringe, er syringe radiation shield that contains a-syringe with a radiopharmaceutical. The label must show the radiopharmaceutical name or its 73
abbreviation, the clinical procedure to be performed, or the patient's or the human research subject's name.
(c) A licensee shall require each individual who prepares a radiopharmaceutical kit to use a syringe radiation shield when preparing the kit and shall require each individual to use a syringe radiation shield when administering a radiopharmaceutical by injection unless the use of the shield is contraindicated for that patient or human research subject.
24, Section 35.75 is revised to read as follows:
5 35.75 Release of patients or human research subjects containing radiopharmaceuticals or permanent implants.
(a) A licensee may not authorize release from confinement for medical care any patient or human research subject administered a radiopharmaceutical until either:
(1) The measured dose rate from the patient or the human research subject is less than 5 millirems per hour at a distance of one meter; or 4
(2) The activity in the patient or the human research subject is less than 30 millicuries.
(b) A licensee may not authorize release from confinement for medical care of any patient or human research subject administered a permanent implant until the measured dose rate from the patient or the human research subject is less than 5 millirems per hour at a distance of one meter.
i l
I 74
30.
Section 35.100 is revised to read as follows:
6 35.100 Use of unsealed byproduct material for uptake, dilution, and excretion studies.
A licensee may use for uptake, dilution, or excretion studies any unsealed byproduct material prepared for medical use that is either:
(a) Obtained from a manufacturer or preparer licensed pursuant to 10 CFR 32.72 or equivalent Agreement State requirements; or (b) Prepared by an authorized nuclear pharmacist, a physician who is an authorized user and who meets the requirements specified in 5 35.920, or an individual under the supervision of either as specified in 5 35.25.
31.
Section 35.200 is revised to read as follows:
l l
6 35.200 Use of unsealed byproduct aaterial for imaging and localization studies.
A licensee may use for imaging and localization studies any unsealed byproduct material prepared for medical use that is either:
(a) Obtained from a manufacturer or preparer licensed pursuant to 10 CFR 32.72 or equivalent Agreement State requirements; or (b) Prepared by an authorized nuclear pharmacist, a physician who is an authorized user and who meets the requirements specified in i 35.920, or an individual under the supervision of either as specified in 6 35.25.
75
1 32.
Section 35.300 is revised to read as follows:
6 35.300 Use of unsealed byproduct material for therapeutic administration.
A licensee may use for therapeutic administration any unsealed byproduct material prepared for medical use that is either:
(a) Obtained from a manufacturer or preparer licensed pursuant to 10 CFR 32.72 or equivalent Agreement State requirements; or (b) Prepared by an authorized nuclear pharmacist, a physician who is an authorized user and who meets the requirements specified in 6 35.920, or an individual undar the supervision of either as specified in 6 35.25.
33.
In 6 35.310, the introductory text of paragraph (a), and paragraphs (a)(1) and (a)(5) are revised to read as follows:
5 35.310 Safety instruction.
(a) A licensee shall provide radiation safety instruction for all personnel caring for the patient or the human research subject receiving radiopharmaceutical therapy and hospitalized for compliance with 6 35.75 of I
this chapter. To satisfy this requirement, the instruction must describe the licensee's procedures for:
(1) Patient or human research subject control; (5) Notification of the Radiation Safety Officer in case of the patient's L
L or the human research subject's death or medical emergency.
76 i
l
34.
In 5 35.315, the introductory text of paragraph (a), and paragraphs (a)(2), (a)(3), (a)(5), (a)(6), (a)(7), and (b) are revised to read as follows:
l 6 35.315 Safety precautions.
(a)
For each patient or human research subject receiving radiopharmaceutical therapy and hospitalized for compliance with 6 35.75 of this chapter, a licensee shall:
)
(2)
Post the patient's or the human research subject's door with a
Radioactive Materials sign and note on the door or in the patient's or human research subject's chart where and how long visitors may stay in the patient's or the human research subject's room; l
(3) Authorize visits by individuals under age 18 only on a case-by-case basis with the approval of the authorized user after consultation with the Radiation Safety Officer; (5)
Either monitor material and items removed from the patient's or the human research subject's room to determine that their radioactivity cannot be distinguished from the natural background radiation level with a radiation detection survey instrument set on its most sensitive scale and with no interposed shielding, or handle them as radioactive waste.
l l
(6) Provide the patient or the human research subject with radiation safety guidance that will help to keep radiation dose to household members and the public as low as reasonably achievable before authorizing release of the l
patient or the human research subject.
77 w
I l
(7) Survey the patient's or the human research subject's room and private
- i sanitary facility for removable contamination with a radiation detection j
l survey instrument before assigning another patient or human research subject:
to the room. The room must not be reassigned until removable contamination is l
less than 200 disintegrations per minute per 100 square centimeters; and (b) A licensee shall notify the Radiation Safety.0fficer immediately if
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(
the patient or the human research subject dies or has a medical emergency.
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35.
Section 35.404 is revised to read'as follows:
i s 35.404 Release of patients or human research subjects treated with 1
temporary implants.
i (a)
Immediately after removing the last temporary implant _ source from a f
patient or a human research subject, the licensee shall make _a radiation
- i survey of the patient or the human research subject with a radiation detection survey instrument to confirm that all' sources have been removed. The licensee l
may not release from confinement for medical care' a patient or a human-research subject treated by temporary implant until all sources have been l
removed.
i (b) A licensee shall retain a record of-patient or human-research subject surveys for three years.
Each record must include the date of the-survey, the name of the patient or the human research subject, the dose rate from the patient or the human research subject expressed as millirem per. hour.
and measured at one meter'from the patient or the human research subject, the 78 m
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survey instrument used, and the initials of the individual who made the survey.
36.
In s 35.406, paragraphs (a), (b), and (c) are revised to read at follows:
s 35.406 Brachytherapy sources inventory.
(a)
Promptly after removing them from a patient or a human research subiect, a licensee shall return brachytherapy sources to the storage area, i
and count the number returned to ensure that all sources taken from the storage area have been returned.
(b) A licensee shall make a record of brachytherapy source use which must include:
(1)
The names of the individuals permitted to handle the sources; (2) The number and activity of sources removed from storage, the patient's or the human research subject's name and room number, the time and date they were removed from storage, the number and activity of the sources in storage after the removal, and the initials of the individual who removed the sources from storage; (3) The number and activity of sources returned to storage, the l
patient's or the human research subject's name and room number, the time and l
date they were returned to storage, the number and activity of sources in 1
storage after the return, and the initials of the individual who' returned the sources to storage.
(c)
Immediately after implanting sources in a patient or a human research subject the licensee shall make a radiation survey of the patient or 79 t
the human research subject and the area of use to confirm that no sources have been misplaced. The licensee shall make a record of each survey.
e 37.
In 5 35.410, the introductory text of paragraph (a), and paragraphs (a)(3) and (a)(5) are revised to read as follows:
9 35.410 Safety instruction.
(a) The licensee shall provide radiation safety Instrection to all personnel caring for the patient or the human research subject undergoing implant therapy. To satisfy this requirement, the instruction must describe:
(3)
Procedures for patient or human research subject control; i
(5)
Procedures for notification of the Radiation Safety Officer if the patient or the human research subject dies or has a medical emergency.
38.
In 5 35.415, the introductory text of paragraph (a), and paragraphs (a)(1), (a)(2), (a)(3), (a)(5) and (b) are revised to read as follows:
6 35.415 Safety precautions.
(a)
For each patient or human research subject receiving implant therapy, a licensee shall:
80
l (1)
Not quarter the patient or the human research subject in the same room with an individual who is not receiving radiation therapy unless the licensee can demonstrate compliance with the requirements of 9 20.105(b) or, for licensees implementing the provisions of 5 5 20.1001-20.2401, 9 20.1301(a) l of this chapter at a distance of one meter from the implant; 1
(2)
Post the patient's or human research subject's door with a
Radioactive Materials sign and note on the door or in the patient's or human research subject's chart where and how long visitors may stay in the patient's or human research subject's room; (3) Authorize visits by individuals under age 18 only on a case-by-case basis with the approval of the authorized user after consultation with the Radiation Safety Officer; and l
(5)
Provide the patient or the human research subject with radiation i
safety guidance that will help to keep radiation dose to household members and the public as low as reasonably achievable before releasing the individual if l
l the individual was administered a permanent implant.
l (b) A licensee shall notify the Radiation Safety Officer immediately if the patient or the human research subject dies or has a medical amergency.
39.
In 6 35.610, paragraph (a)(1) is revised to read as follows:
i 6 35.610 Safety instruction.
(a)
(1)
The procedure to be followed to ensure that only the patient or the human research subject is in the treatment room before turning the primary 81 I
1 i
beam of radiation on to begin a treatment or after a door interlock j
j interruption; i
40.
In 5 35.615, paragraphs (d)(3) and (e) are revised to read as follows:
6 35.615 Safety precautions.
l i
i, u )
l i
I (3) A radiation monitor must be checked with a dedicated check source for proper operation each day before the teletherapy unit is used for treatment of patients or human research subjects.
l j
(e) A licensee shall construct or equip each teletherapy room to permit I
continuous observation of the patient or the human research subject from the teletherapy unit console during irradiation.
41.
In 6 35.900, paragraphs (a)(6) and (a)(7) are added to read as follows:
I 35.900 Radiation Safety Officer.
(a)
(6) American Board of Medical Physics in radiation oncology physics; or 82 1
(7)
Royal College of Physicians and Surgeons of Canada in Nuclear medicine; or 42.
In 6 35.910, paragraph (a)(4) is added and paragraphs (b)(2)(i),
(b)(2)(iii), and (b)(2)(v) are revised to read as follows:
5 35.910 Training for uptake, dilution, and excretion studies.
(a)
(4) Nuclear medicine by the Royal College of Physicians and Surgeons of Canada; or (b)
(2)
(i)
Examining patients or human research subjects and reviewing their case histories to determine their suitability for radioisotope diagnosis, limitations, or contraindications; (iii) Administering dosages to patients or human research cubjects and using syringe radiation shields; (v)
Patient or human research subject followup; or l
43.
In s 35.920, paragraph (a)(4) is added and paragraphs (b)(2)(iii),
(b)(3)(i), (b)(3)(iii), and (b)(3)(v) are revised to read as follows:
83 4
0 9 35.920 Training for imaging and localization studies.
(a)
(4)
Nuclear medicine by the Royal College of Physicians and Surgeons of Canada; or (b)
(2)
(iii) Calculating and safely preparing patient or human research subject dosages; (3)
(i)
Examining patients or human research subjects and reviewing their case histories to determine their suitability for radioisotope diagnosis, limitations, or contraindications; (iii) Administering dosages to patients or human research subjects and using syringe radiation shields; (v) Patient or human research subject followup; or 44.
In 5 35.930, paragraph (a)(2) is revised to read as follows:
1 35.930 Training for therapeutic use of unsealed byproduct material.
(a) 84
l (2)
The American Board of Radiology in radiology, therapeutic radiology, or radiation oncology; or 45.
In 6 35.940, paragraph (a)(1) is revised to read as follows:
s 35.940 Training for use of brachytherapy sources.
I f
(a) l l
(1)
Radioicgy, therapeutic radiology, or radiation oncology by the j
l i
American Board of Radiology; i
i l
46.
In 6 35.950, paragraphs (a)(1) and (a)(4) are revised to read as follows:
s 35.950 Training for use of sealed sources for diagnosis.
(a)
(1)
Radiology, diagnostic radiology, therapeutic radiology, or radiation oncology by the American Board of Radiology; I
(4) Nuclear medicine by the Royal College of Physicians and Surgeons of Canada; or l
l 85 l
l
t e
47.
In 5 35.960, paragraphs (a)(1)*and (b)(3)(iii) are revised to read as follows:
l 35.960 Training for teletherapy.
(a)
(1) Radiology, therapeutic radiology, or radiation oncology by the American Board of Radiology; (b)
(3)
(iii)
Calculating the teletherapy doses and collaborating with the authorized user in the review of patients' or human research subjects' progress and consideration of the need to modify originally prescribed doses as warranted by patients' or human research subjects' reaction to radiation; and 48.
In 6 35.961, paragraph (b) is redesignated as paragraph (c) and a j
new paragraph (b) is added to read as follows:
9 35.961 Training for teletherapy physicist.
(b)
Is certified by the American Board of Medical Physics in radiation oncology physics; or 86
i 49.
Section 35.972 is revised to read as follows:
5 35.972 Recentness of training.
The training and experience specified in this subpart must have been obtained within the seven years preceding the date of application or the individual must have had related continuing education and experience since the required training and experience was completed.
50.
Section 35.980 is added to read as follows:
6 35.980 Training for an authorized nuclear pharmacist.
The licensee shall require the authorized nuclear pharmacist to be a pharmacist who:
(a) Has current board certification as a nuclear pharmacist by the Board of Pharmaceutical Specialties, or (b)(1) Has completed 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> in a structured educational program consisting of both:
(i)
Didactic training in the following areas:
(A)
Radiation physics and instrumentation; (B)
Radiation protection; (C) Mathematics pertaining to the use and measurement of radioactivity; (D) Chemistry of byproduct material for medical use; and (E) Radiation biology; and -
(ii) Supervised experience in a nuclear pharmacy involving the following:
(A)
Shipping, receiving, and performing related radiation surveys; 87 l
l l
L (B) Using and performing checks for proper operation of dose calibrators, survey meters, and, if appropriate, instruments used to measure alpha-or beta-emitting radionucit'es; (C) Calculating, assaying, and safely preparing dosages for patients or human research subjects; (D) Using administrative controls to avoid mistakes in the t
administration of byproduct material; j
(E) Using procedures to prevent or minimize contamination and using i
proper decontamination procedures; and (2) Has obtained written certification, signed by a preceptor authorized nuclear pharmacist, that the above training has been satisfactorily-I completed and that the individual has achieved a level of competency 1
i sufficient to independently operate a nuclear pharmacy.
l t
Dated at Rockville, Maryland,.this day of June-
- 1993, For the-Nuclear Regulatory Commission.
O'
]
N'
- ' Samuel J. Chil k, N
~O n{'
Secretary of the Commission.
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