ML20247H963

Notice of Receipt of American College of Nuclear Physicians & Society of Nuclear Medicine Petition for Rulemaking PRM-35-9,dtd 890605 Requesting NRC Permit Nuclear Physicists to Determine Therapeutic Applications of Radiopharms

ML20247H963
Person / Time
Issue date:	09/08/1989
From:	Chilk S NRC OFFICE OF THE SECRETARY (SECY)
To:	NRC COMMISSION (OCM)
References
FRN-54FR38239, RULE-PRM-35-9 NUDOCS 8909200164
Download: ML20247H963 (13)

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WC PETITION RULE (Pl FR 3G34) U590-00 89 SEP -8 P3:12 NUCi. EAR REGULATORY COMMISSION 10'CFRParts30,33,and35[

[DocketNo.PRM-35-9]

American College of Nuclear Physicians and the Society of Nuclear Medicine; Receipt of Petition for Rulemaking

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L AGENCY: Nuclear Regulatory Comission ACTION: Petition for rulemaking; notice of receipt.

SUMMARY

The Comission is publishing for public coment a notice of-receipt of a petition for rulemaking dated June 5,1989, which was filed with the Comission by the American College of Nuclear Physicians and the Society of Nuclear Medicine. The petition was docketed by the Comission on June 8, 1989, and has been assigned Docket No. PRM-35-9. The petitioners request that the Comission revise its regulations to give cognizance to the appropriate scope of their practice of medicine snd pharmacy and thereby allow nuclear physicians and nuclear pharmacists to reconstitute non-radioactive kits differently from the method recomended by the manufacturer; allow nuclear physicians and nuclear pharmacists to prepare radiopharmaceuticals whose manufacture and distribution are not regulated by FDA; and permit nuclear physicians to determine appropriate diagnostic and therapeutic applications of radiopharmaceuticals.

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DATC: Submit coments by December 14, 1989.

Comments received after this date will be considered if it is practical to do so, but the Comission is able to assure consideration only for comments received on or before this cate.

ADDRESSES: All persons who desire to submit written comments concerning the petition for rulemaking should send their comments to the Secretary of the Comission, U. S. tJuclear Regulatory Comission, Washington, DC 20555, f.ttention: Docketing and Service Branch.

Deliver coments to the One White Flint North Building,11555 Rockville Pike, Rockville, Maryland between 7:30 a.m. and 4:15 p.m., Federal workdays.

For a copy of the petition, write the Regulatory Publications Branch, Division of Freedom of Information and Publications Services, Office of Administration, U. S. Nuclear Regulatory Comission, Washington., DC 20555.

The petition and copies of coments receiveo may be inspected and copied for a fee at the NRC Public Document Room, 2120 L Street, NW. (Lower Level),

Washington, DC.

FOR FURTHER INFORMATION CONTACT: Michael T. Lesar, Acting Chief, Rules Review Section, Regulatory Publications Branch, Division of Freedom of Information and Publications Services, Office of Administration, U. S. Nuclear 2

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l' g l Regulatory Commission, Washington,'DC 20555, Telephone: 301-492-7758 or Toll Free: 80,0-368-5642.

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- SUPPLEMENTARY INFORMATION: i Petitioners I

The American College of Nuclear Physicians (ACNP) and the Society of

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Nuclear' Medicine (SNM) are comprised of over 12,000 individuals who i participate in the medical use of byproduct material. Members' include a l

. physicians, technologists and nuclear pharmacists. The physicians supervise l the preparation and administration of radiopharmaceuticals to diagnose and l l

treat patients. Technologists administer radiopharmaceuticals and perform clinical procedures under the direction and supervision of an authorized user l J

physician. Nuclear pharmacists reconstitute radiopharmaceutical kits, compound radiopharmaceuticals, and cispense radiopharmaceuticals for medical purposes.

Petitioner's Interest

, The petitioners are interested in the requested action because under current NRC regulations, members of the petitioning organizations believe they cannot appropriately practice their professions. The petitioners state that authorized user physicians cannot prescribe certain radiopharmaceuticals or routes of administration for optimal patient care, even though they are 3

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permitted to do so by the Food and Drug Administration (FDA) and by their state medical licenses. Acc0rding to the petitioners, nuclear pharmacists )

l have been disenfranchised as a professional entity because activities that '

are permitted by the FDA and the states are not allowed under NRC regulations.

The petitioners state that although a nuclear pharmacist is authorized by state license to prepare raciopharmaceuticals for patient administration upon receipt of a prescription by an authorized user physician, current NRC regulations severely restrict their activity to rigid reconstitution of standard kits and to dispensing doses of radiopharmaceuticals distributed by manufacturers. Nuclear medicine technologists reconstitute radiopharma-ceuticals and perform clinical procedures under the supervision of an authorized user physician. The petitioners believe that their professional activities are curtailed by the limitations imposed on nuclear physicians and pharmacists.

Background

The petitioners begin the petition with a recitation of the following:

"At the time the Atomic Energy Act of 1954 was passed, the FDA did not regulate radioactive drugs (although they had the mandate to do so). FDA began regulating accelerator-produced radiopharmaceuticals in 1968 and began regulating byproduct radiopharmaceuticals in 1974. Until that time, the 4

4 preparation and use of raciopharmaceuticals maoe from byproduct material had been regulated solely by the Atomic Energy Commission (now the Nuclear Regulatory Commission). As yu.rs passed FDA continued to refine its role in reviewing, approving, and regulating radiopharmaceuticals for research and clinical purposes."

FDA now regulates all radiopharmaceuticals, whether made by manufacturers, nuclear pharmacists or their designees in medical institutions or in centralized radiopharmacies, or nuclear physicians or their designees. FDA has the Federal authority to regulate all research and clinical use of radioactive drugs directly or indirectly. Because of the exemption from manufacturing and distribution requirements of the FDA for pharmaceuticals (including radiopharmaceuticals) prepared under State laws regulating the practice of medicine and pharmacy, commercial New Drug Applications are not granted for these drug preparations. These drugs are still recognized and regulated by FDA.

The practices of medicine and pharmacy are exempt from FDA's manufacturing ano distribution regulations by congressional mandate, but they are not exempt from FDA's regulations forbidoing misbranding and adulteration.

The FDA is the enforcement arm of the drug quality standards published in the United States Pharmacopoeia.

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Petitioner's Proposal The petitioners propose the following amendments.

1. Define " medical research use" in 10 CFR 30.4 as follows:

" Medical Research Use" means the intentional internal or external administration of byproduct material, or the radiation therefrom, to human subjects for research purposes.

2. Define "radiopharmaceutical" in 10 CFR 35.2 as follows:

"Radiopharmaceutical" means any drug or biologic that contains byproduct material.

3. Define " medical research use" in 10 CFR 35.2 as follows:

" Medical Research Use" means the intentional internal or external administration of byproduct material, or the radiation therefrom, to human subjects for research purposes.

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4. Redefine " medical institution" in 10 CFR 35.2 as follows:

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" Medical Institution" means a single health ture facility or a health care organization which may physically exist in multiple separate locations but is integrated through economic and/or management agreements. Several medical disciplines may be practiceo in a medical institution.

5. With regard to Practice of Pharmacy, Practice of Medicine, and Medical Research, the petitioners recommend the following amendments to 6635,100, 35.200, and 35.300:

Section 35.100.

(a) A licensee may use for medical use any byproduct material in a radiopharmaceutical and for a diagnostic use involving measurements of uptake, dilution, or excretion in which:

(1) The radiopharmaceutical is manufactured and distributed in accordance with the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, or:

(2) The radiopharmaceutical is manufactured, prepared. propagated, compounded, or processed under an exempt category of Section 510(g) of the Federal Food, Drug and Cosmetic Act.

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(b) A medical institution licensee may use for medical research use any byproduct material in a radiopharmaceutical and for a use involving measurements of uptake, dilution, or excretion if its use has been approved by the Radiation Safety Committee (RSC) and the Institutional Review Board (IRB) chartered in accordance with 45 CFR

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Part 46.

Section 35.200. {

(a) ' A ' licensee may use for medical use any byproduct material in a radiopharmaceutical and for a diagnostic use involving imaging in which:

(1) The radiopharmaceutical is manufactured and distributed in accordance with the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, or:

(2) The radiopharmaceutical is manufactured, prepared, propagated, compounded or processed under an exempt category of Section 510(g) of the Federal Food, Drug, and Cosmetic Act.

(b) A medical institution licensee may use for medical research use any byproouct materiel in a radiopharmaceutical and for a use involving j imaging if its use has beelt approved by the RSC and the IRB chartereo in accordance with 45 CFR Part 46.

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Section 35.300.

(a) A licensee may use for medical use' any byproduct material in a radiopharmaceutical and for a therapeutic use in which:

(1) The radiopharmaceutical is manufactured and distributed in accordance with the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, or:

(2) The radiopharmaceutical is manufactured, prepared, propagated, compounded, or processed under an exempt category of Section 510(g)oftheFederalFood, Drug,andCosmeticAct.

(b) A medical institution licensee nay use for medical research use any byproduct material in a radiopharmaceutical for a therapeutic use if its use has been approved by the RSC and the IRB chartered in accordance with 45 CFR Part 46,

6. With regard to NRC licenses, the petitioners recommend the addition of a new paragraph to 10 CFR 35.11.

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4 (c): Any medical institution licensed to use byproduct material for medical use as' described in sections 35.100, 35.200 or 35.300 may also use byproduct material for medical research use oescribed in the sections for which it is licensed.-- This authorization supersedes any license condition issued before (insert effective .

date).

- 7. With regard to suppliers, the petitioners recommend inserting a new paragraph to 10 CFR 35.49 and rename paragraph (c) as paragraph (d).

(c) Byproduct material in raciopharmaceuticals compounded by or under the supervision of a state-licensed nuclear pharmacist or nuclear medicine physician ~if such radiopharmaceuticals are manufactured, prepared, propagated, compounded, or processed under an exempt category of Section 510(g) of the Federal Food, Drug, and Cosmetic Act.

S. With regaro to free-standing radiopharmacies the petitioners request that hRC revise the regulations to allow free-standing radiopharmacies licensed under 10 CFR 32.72 and 10 CFR 32.73 to also compound radiopharmaceuticals.

l The petitioners believe that this must be accomplished by licensing action because those licenses have a clause that states that if the license document is nore restrictive than the regulation, the license document takes precedence.

According to petitioners, those licenses should be amended by NRC, without 10

charge to the licensee, to remove the requirement to reconstitute raaicpharmaceuticals in accordance with the manufacturer's instruction.

Petitioners believe that in the event of any disciplinary action by NRC, the applicable State Board of Pharmacy should be alerted.

9. With regard to specific licenses of broad scope for medical research use, the petitioners request 10 CFR 33.11(a) be amended as follows:

(a) A " Type A specific license of broad scope" is a specific license authorizing receipt, acquisition, ownership, possession, use, and transfer of any chemical or physical form of the byproduct material specified in the license, but not exceeding quantities specified in the license, for purposes authorized by the Act. The quantities specified are usually in the multicurie range. Applicants that are medical institutions may conduct medical research use in addition to conducting research and development as defined in 10 CFR 30.4.

10. The petitioners recomend that 10 CFR 33.13(c)(3) be amendeo by adding a new paragraph (iv)asfollows:

(iv) Review, approval, ana recording by the Radiation Safety Comittee and the Institutional Review Board of the Safety and ethics of proposed uses invciving medical'research use prepared in accordance with paragraph (c)(3)(11) of this section prior to use of the byproduct material.

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• I 11. Finally,.the petitioners recommend that 10 CFR 33.17(a)(4) be amended to 1x read as follows:

(4) Add or cause the addition of byproduct material to any food, beverage, cosmetic, drug, or other product designed for: ingestion or inhalation'by, or application to, a human being unless permitted by the license document to conduct medical research use.

Grounds for Petition The petitioners request that the NRC revise its regulations to give cognizance to the appropriate scope of the practice of medicine and pharmacy.

The petitioners believe that 10 CFR Part 35 should be revised to recognize all the mechanisms that FDA uses to authorize the use of radiopharmaceuticals.

According to the petitioners, granting of this petition would allow nuclear physicians and nuclear pharmacists to reconstitute non-radioactive kits differently from the method recommended by the manufacturer; allow nuclear physiciars and nuclear pharmacists to prepare radiopharmaceuticals whose manufacture and distribution are purposefully not regulated by FDA; and permit nuclear physicians to determine appropriate diagnostic and therapeutic applications of radiopharmaceuticals, as is their professional obligation, 12

'4 Statement in Support The petitioners state that NRC mentions only two FDA compliance mechanisms. The two mechanisms cited are the approved Investigational New Drug Application (IND) and the approved New Drug Application (NDA).

Petitioners state that there are other mechanisms to achieve FDA compliance which the petitioners believe should be adoed to NRC's regulations. According to petitioners, mechanisms are approval via Product License Application (PLA),

I Radioactive Drug Research Committee approval (RDRC) Institutional Review

.Boaroapproval(IRB), ,

The petitioners believe that 10 CFR Part 35 directly conflicts with FDA's regulatory framework. The petitioners state that except for phys 1cian sponsored  ;

" Notice of Claimed Investigational Exemptions" (IND),10 CFR Part 35 only ]

i allows the use of radiopharmaceuticals preparea under the portion of FDA regulations devoted to manufacturers with nationwide distribution. The petitioners believe that regulatory incompatibility between NRC regulations,  !

FDA regulations, and state pharmacy and medicine laws is causing serious problems in the optimal delivery of quality nuclear medicine care and the implementation of nuclear medicine research.

I Dated at Rockville, Maryland this day of 0 % M , 1989.

ir the Nucl ear Regulatory Commission.

bb JSamuel J. Cht%,

l Secretary of the Commission.

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