ML20057B192
| ML20057B192 | |
| Person / Time | |
|---|---|
| Issue date: | 08/02/1991 |
| From: | Telford J NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| To: | Catizone C, Hupf H, Kalman S External (Affiliation Not Assigned) |
| Shared Package | |
| ML19342C263 | List: |
| References | |
| FRN-58FR33396, RULE-PR-30, RULE-PR-32, RULE-PR-35 AD69-1-003, AD69-1-3, NUDOCS 9309200140 | |
| Download: ML20057B192 (16) | |
Text
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AUG 0 21991 r
Mr. Sam Kalman, Board Secretary Board of Pharmaceutical Specialties Q](N
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221S Constitution Avenue, NW
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Dear Mr. Kalman:
In a letter dated July 19, 1991 inviting your organization to participate in the workshop on " authorized radiopharmacist," we stated that we would present a proposed strawman. A draft of our proposed strawman is enclosed for your consideration.
We would appreciate it if the participants would review the proposed strawman and be prepared to discuss it and offer alternative solutions for these topics with the supporting rationale during the workshop.
Instead of Mr. David Laven, Mr. Henry Chilton will represent 'the American Society of Hospital Pharmacists.
I am looking forward to meeting the participants at the workshop on August 7, 1991.
Sincerely, John Telford, Chief Rulemaking Section Regulation Development Branch Division of Regulatory Applications Office of Nuclear Regulatory Research
Enclosure:
Draft strawman DISTRIBUTION: (w/ encl.)
Subj-circ-chron IDENTICAL LETTERS SENT TO THOSE RDB reading file (SBahadur)
ON ENCLOSED LIST BMorris FCostanzi JTelford ATse JGlenn, NMSS LCamper, NMSS LBolling, GPA N
OFF:
RDB/DP, RES RDB(DRA/RES NAME:
ATse JTelford DATE:
7/30/
7/jD/91 0FFICIAL RECORD COPY t
J g92 140 93o908 30 SOFR33396 ppg _
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Identical Letters Sent To:
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Mr.' Sam Kalman, Board Secretary Board of Pharmaceutical Specialties 2215 Constitution Avenue, NW Washington, DC 20037 Dr. Homer Hupf, President American Board of Science in Nuclear Medicine 3341 Cadencia Street Carlsbad, Ca 92009 Mr. Carmen A. Catizone, Executive Director National Association of Boards of Pharmacy 1300 Higgins Road Park Ridge, IL 60068 Mr. Henry Kramer, Chairman l
Committee on Radionuclides and i
Radiopharmaceuticals US Council for Energy Awareness 3911 Campolindo Drive i
Moraga, CA 94556 Dr. Dennis Eshima College of Pharmacy Radiopharmacy University of New Mexico Albuquerque, NM 87131
'I Mr. Dennis Swanson School of Pharmacy 1111 Salk Hall University of Pittsburgh Pittsburgh, PA 15261 Ms. Anne Smith, Director Nuclear Pharmacy Program School of Pharmacy and Pharmaceutical Sciences Purdue University Robert E. Heine Pharmacy Building West Lafayette, IN 47907 Mr. Brian Hyps Associate Director for Government Affairs American Pharmaceutical Association i
2215 Constitution Avenue, NW Washington, DC 20037 Ms. Beverly Black, Director Federal Regulatory Affairs American Society of Hospital Pharmacists 4630 Montgomery Avenue Bethesda, MD 20814
DRAFT REGULATORY. APPROACH FOR ESTABLISHING AN " AUTHORIZED RADIOPHARMACIST."
TOPIC 1 - ACCEPTED CERTIFICATIONS.
AN " AUTHORIZED RADIOPHARMACIST" IS A PHARMACIST WHO IS CURRENTLY CERTIFIED AS A NUCLEAR PHARMACY SPECIALIST BY THE BOARD OF PHARMACEUTICAL SPECIALTIES'OF THE AMERICAN ~
PHARMACEUTICAL ASSOCIATION.
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DRAFT REGULATORY APPROACH FOR ESTABLISHING AN " AUTHORIZED RADIOPHARMACIST" TOPIC 2 - EDUCATION AND EXPERIENCE CRITERIA IN LIEU OF CERTIFICATION.
AN " AUTHORIZED RADIOPHARMACIST" IS A PHARMACIST WHO HAS:
(a)
EITHER A B.S. DEGREE IN PHARMACY OR PHARM. D. FROM A SCHOOL OF PHARMACY ACCREDITED BY THE AMERICAN COUNCIL ON PHARMACEUTICAL EDUCATION:
(b)
A CURRENT LICENSE TO PRACTICE PHARMACY; (c) 4000 HOURS OF PROFESSIONAL EXPERIENCE IN NUCLEAR PHARMACY PRACTICE IN A LICENSED NUCLEAR PHARMACY OR HEALTH-CARE FACILITY APPROVED BY AN AGREEMENT STATE OR THE NRC TO 2
DRAFT REGULATORY APPROACH FOR ESTABLISHING AN " AUTHORIZED RADIOPHARMACIST" L
TOPIC 2 - EDUCATION AND EXPERIENCE CRITERIA IN LIEU OF CERTIFICATION.
(CONTINUED).
HANDLE BYPRODUCT MATERIALS, AND EXPERIENCE CREDIT MAY BE GRANTED FOR UP TO 2,000 HOURS ACCORDING TO THE FOLLOWING:
(i)
. PHARMACISTS WHO HAVE COMPLETED A PH.D OR M.S! PROGRAM IN NUCLEAR PHARMACY MAY BE GRANTED UP TO 2,000 HOURS EXPERIENCE CREDIT, (ii)
PHARMACISTS WHO HAVE COMPLETED' UNDERGRADUATE OR POSTGRADUATE COURSES IN NUCLEAR PHARMACY MAY BE GRANTED UP.TO 100 HOURS PER QUARTER HOUR OR 150 HOURS.
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i DRAFT REGULATORY APPROACH FOR ESTABLISHING AN " AUTHORIZED RADIOPHARMACIST" TOPIC 2 - EDUCATION AND EXPERIENCE CRITERIA IN LIEU OF CERTIFICATION.
(CONTINUED)
PER SEMESTER HOUR UP TO A MAXIMUM OF 1,500 HOURS EXPERIENCE CREDIT, (iii). PHARMACISTS WHO HAVE PARTICIPATED IN RESIDENCY PROGRAMS IN NUC;. EAR PHARMACY MAY BE GRANTED CREDIT ON AN HOUR-FOR-HOUR: BASIS FOR TIME SPENT IN ACTUAL NUCLEAR PHARMACY PRACTICE UP TO A MAXIMUM OF 2,000 HOURS EXPERIENCE CREDIT, AND 4
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DRAFT REGULATORY APPROACH FOR ESTABLISHING AN " AUTHORIZED RADIOPHARMACIST" TOPIC 2 - EDUCATION AND EXPERIENCE CRITERIA IN LIEU OF CERTIFICATION.
(CONTINUED)
(iv)
PHARMACISTS WHO HAVE PARTICIPATED IN INTERNSHIP PROGRAMS TO SATISFY REQUIREMENTS OF STATE BOARDS OF
. PHARMACY MAY BE GRANTED CREDIT ON AN HOUR-FOR-HOUR BASIS FOR TIME SPENT IN ACTUAL NUCLEAR PHARMACY PRACTICE
- UP TO A MAXIMUM OF 2,000 HOURS EXPERIENCE CREDIT; AND i
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DRAFT REGULATORY APPROACH FOR ESTABLISHING AN " AUTHORIZED RADIOPHARMACIST" TOPIC 2 - EDUCATION AND EXPERIENCE CRITERIA IN LIEU OF CERTIFICATION.
(CONTINUED)
(d) 1000 HOURS OF SYSTEMATIC INSTRUCTION BY AN AUTHORIZED RADIOPHARMACIST AT A NUCLEAR PHARMACY WITH A MINIMUM OF 100 HOURS FOR EACH OF THE FOLLOWING:
(i)
PROCUREMENT OF RADIOPHARMACEUTICALS, (ii)
COMPOUNDING OF RADIOPHARMACEUTICALS, (iii)
PERFORMANCE OF APPROPRIATE QUALITY-CONTROL PROCEDURES, (iv)
DISPENSING OF RADIOPHARMACEUTICALS, 6
DRAFT REGULATORY APPROACH FOR ESTABLISHING AN " AUTHORIZED RADIOPHARMACIST" TOPIC 2 - EDUCATION AND EXPERIENCE CRITERIA IN LIEU OF CERTIFICATION.
(CONTINUED)
(v)
DISTRIBUTION OF RADIOPHARMACEUTICALS, (vi)
IMPLEMENTATION OF BASIC RADIATION PROTECTION PROCEDURES
. AND PRACTICES, SUCH AS, PERSONNEL MONITORING, RECElPT OF RADIOACTIVE MATERIALS, CHECKING SURVEY METERS FOR PROPER OPERATION, PERFORMING RADIATION SURVEYS, 7
DRAFT REGULATORY APPROACH FOR ESTABLISHING AN " AUTHORIZED RADIOPHARMACIST" TOPIC 2 - EDUCATION AND EXPERIENCE CRITERIA IN LIEU OF CERTIFICATION.
(CONTINUED)
STORAGE, TRANSFER, SHIELDING, SECURITY, SAFETY, EQUIPMENT CAllBRATION, ENVIRONMENTAL MONITORING, RADIOACTIVE WASTES, POSTING OF AREAS, AND EVALUATION OF RADIATION PROTECTION, AND (vii) CONSULTATION PROVIDED TO THE NUCLEAR MEDICINE COMMUNITY, PHARMACISTS, PATIENTS, 8
DRAFT REGULATORY APPROACH FOR ESTABLISHING AN " AUTHORIZED RADIOPHARMACIST" TOPIC 2 - EDUCATION AND EXPERIENCE CRITERIA IN LIEU OF CERTIFICATION.
(CONTINUED)
OTHER HEALTH PROFESSIONALS, AND THE GENERAL PUBLIC REGARDING:
.(1)
THE PHYSICAL AND CHEMICAL PROPERTIES OF RADIOPHARMACEUTICALS, (2)
PHARMACOKINETICS AND EilODISTRIBUTION OF RADIOPHARMACEUTICALS, AND (3)
DRUG INTERACTIONS AND OTHER FACTORS THAT ALTER PATTERNS OF DISTRIBUTION.
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DRAFT REGULATORY APPROACH FOR ESTABLISHING AN " AUTHORIZED RADIOPHARMACIST" TOPIC 3 - SUPERVISION OF PHARMACISTS OR INDIVIDUALS WORKING AS PHARMACISTS PROVIDED BY~AN AUTHORIZED RADIOPHARMACIST.
THE AUTHORIZED RADIOPHARMACIST SHALL:
l (a)
INSTRUCT THE SUPERVISED INDIVIDUAL IN THE PRACTICE OF NUCLEAR PHNRMACY AND THE PRINCIPLES OF RADIATION SAFETY; (b)
DEVELOP AND IMPLEMENT APPROPRIATE PROCEDURES TO ENSURE THAT.THE RIGHT RADIOPHARMACEUTICAL IN THE RIGHT DOSAGE FORM-IS PREPARED AND LABELED CORRECTLY FOR:
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DRAFT REGULATORY APPROACH FOR ESTABLISHING AN " AUTHORIZED RADIOPHARMACIST" TOPIC 3 - SUPERVISION OF PHARMACISTS OR INDIVIDUALS WORKING AS PHARMACISTS PFDVIDED BY AN AUTHORIZED RADIOPHARMACIST.
(CONTINUED)
(i)
DIAGNOSTIC AND THERAPEUTIC RADIOPHARMACEUTICAL
. DOSAGES GREATER THAN 30 MICROCURIES OF EITHER~ SODIUM IODIDE l-125 OR l-131, AND (ii)
. ALL OTHER THERAPEUTIC RADIOPHARMACEUTICALS; 11
DRAFT REGULATORY APPROACH FOR ESTABLISHING AN " AUTHORIZED RADIOPHARMACIST" TOPIC 3 - SUPERVISION OF PHARMACISTS OR INDIVIDUALS WORKING AS PHARMACISTS PROVIDED BY AN AUTHORIZED RADIOPHARMACIST.
(CONTINUED)
(c)
REQUIRE THE SUPERVISED INDIVIDUAL TO FOLLOW THE INSTRUCTIONS OF THE AUTHORIZED RADIOPHARMACIST, AND TO COMPLY WITH THE REGULATIONS OR LICENSE CONDITIONS OF NRC (THE LICENSEE MAY BE SUBJECT TO OTHER FEDERAL REQUIREMENTS APPLICABLE TO RADIOPHARMACEUTICALS);
(d)
PERIODICALLY REVIEW THE SUPER. VISED INDIVIDUAL'S WORK; (e)
BE RESPONSIBLE FOR THE ACTS AND OMISSIONS OF THE SUPERVISED INDIVIDUAL IN THE PRACTICE OF NUCLEAR PHARMACY; 12
DRAFT REGULATORY APPROACH FOR ESTABLISHING AN " AUTHORIZED RADIOPHARMACIST" TOPIC 3 - SUPERVISION OF PHARMACISTS OR INDIVIDUALS WORKING AS PHARMACISTS PROVIDED BY AN AUTHORIZED RADIOPHARMACIST.
(CONTINUED)
(f)
PROVIDE SUPERVISION FOR ROUTINE COMPOUNDING BY:
(i)
. APPROVING A PROCEDURES MANUAL FOR THE FREPARATION OF RADIOPHARMACEUTICALS TO BE USED BY THE SUPERVISED INDIVIDUAL AND BEING AVAILABLE FOR CONSULTATION WHENEVER NEEDED, OR (ii)
BEING PHYSICALLY PRESENT IN THE NUCLEAR PHARMACY DURING THE COMPOUNDING; AND 13
DRAFT REGULATORY APPROACH FOR ESTABLISHING AN " AUTHORIZED RADIOPHARMACIST" TOPIC 3 - SUPERVISION OF PHARMACISTS OR INDIVIDUALS WORKING AS PHARMACISTS PROVIDED BY AN AUTHORIZED RADIOPHARMACIST.
(CONTINUED)
(g)
PROVIDE DIRECT SUPERVISION FOR NON-ROUTINE COMPOUNDING BY:
(i)
BEING IN THE PHYSICAL PRESENCE OF THE INDIVIDUAL' PERFORMING THE COMPOUNDING IN ORDER TO ALLOW OBSERVANCE AND DIRECT SUPERVISION, AND (ii)
LIMITING THE DIRECT SUPERVISION TO A MAXIMUM OF 6 INDIVIDUALS.
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