N.H. Admin. Code § Ph 405.03

Current through Register No. 50, December 12, 2024

Section Ph 405.03 - General Requirements for Pharmacies Providing Radiopharmaceutical Services

(a) A permit to operate a pharmacy which provides radiopharmaceutical services shall only be issued to a person who is, or who employs, a qualified nuclear pharmacist. All personnel performing tasks in the preparation and distribution of radiopharmaceuticals and ancillary drugs shall be under the direct supervision of a qualified nuclear pharmacist, who shall be in personal attendance when the pharmacy is open for business. The pharmacist-in-charge shall be responsible for all operations of the pharmacy.

(b) The nuclear pharmacist who licenses the pharmacy shall hold a current license issued by the board, and be either certified as a nuclear pharmacist by the board of pharmaceutical specialties or satisfy each of the following requirements:

(1) Meets minimal standards of training for status as authorized user of radioactive material, as specified by the department of health and human services, bureau of radiological health;

(2) Has successfully completed a minimum of 200 contact hours of instruction in nuclear pharmacy and the safe handling and use of radioactive materials from a nationally accredited college of pharmacy, or other training program recognized by the department of health and human services, bureau of radiological health;

(3) The 200 hours of instruction referenced in (2) above shall be apportioned as follows:

a. Radiation physics and instrumentation, 85 hours;

b. Radiation protection, 45 hours;

c. Mathematics pertaining to the use and measurement of radioactivity, 20 hours;

d. Radiation biology, 20 hours; and

e. Radiopharmaceutical chemistry, 30 hours;

(4) Has attained a minimum of 500 hours of clinical/practical nuclear pharmacy training under the supervision of a qualified nuclear pharmacist in, but not limited to, the following areas:

a. Procuring radioactive materials;

b. Compounding radiopharmaceuticals;

c. Performing routine quality control procedures;

d. Dispensing radiopharmaceuticals;

e. Distributing radiopharmaceuticals;

f. Implementing basic radiation protection procedures; and

g. Consulting and educating the nuclear medicine community, patients, pharmacists, other health professionals, and the general public; and

(5) Has submitted an affidavit of experience and training to the board.

(c) The permit to operate a nuclear pharmacy shall be effective only so long as the pharmacy also holds a current license issued by the department of health and human services, bureau of radiological health. Copies of the bureau of radiological health inspection reports shall be available at the pharmacy for board inspection.

(d) Nuclear pharmacies shall have adequate space and equipment, commensurate with the scope of services required and provided and meeting minimal space requirements established for all pharmacies in the state.

(e) All pharmacies handling radiopharmaceuticals shall include, but not be limited to, the following areas:

(1) Radiopharmaceutical preparation/dispensing area;

(2) Radioactive material shipping/receiving area;

(3) Radioactive material storage area; and

(4) Radioactive waste decay area.

(f) The application for a permit to operate a nuclear pharmacy shall be the same as in Ph 304.01 and Ph 304.02.

(g) The nuclear pharmacy professional service area shall be secured from unauthorized personnel and shall be totally enclosed and lockable.

(h) Nuclear pharmacies shall maintain records of acquisition, inventory and disposition of all radioactive drugs and other radioactive materials in accordance with the board and the department of health and human services, bureau of radiological health statutes and rules.

(i) A radiopharmaceutical shall be dispensed only to a licensed practitioner authorized by the department of health and human services, bureau of radiological health to possess, use and administer such drug. A radiopharmaceutical shall be dispensed only upon receipt of a prescription or medication order from such licensed practitioner. Otherwise, a radiopharmaceutical may be transferred to a person who is authorized to possess and use such drug for non-clinical applications.

(j) A nuclear pharmacy, upon receiving an oral prescription order for a radiopharmaceutical, shall immediately have the prescription order reduced to writing, or recorded in a data processing system.

(k) The writing or record required by (i) above shall contain at least the following:

(1) The name of the institution and prescriber, or prescribers' agent;

(2) The date of dispensing and the calibration time of the radiopharmaceutical;

(3) The name of the procedure;

(4) The name of the radiopharmaceutical;

(5) The dose or quantity of the radiopharmaceutical;

(6) The serial number assigned to the order for the radiopharmaceutical;

(7) Any specific instructions;

(8) The initials of the person who received the order; and

(9) The initials of the person who dispensed the order.

(l) Whenever an order is for a therapeutic or blood-product radiopharmaceutical, the patient's name shall be obtained and recorded prior to dispensing.

(m) The immediate outer container shield of a radiopharmaceutical to be dispensed shall be labeled with:

(1) The name and address of the pharmacy;

(2) The name of the prescriber;

(3) The date of dispensing;

(4) The serial number assigned to the order for the radiopharmaceutical;

(5) The standard radiation symbol;

(6) The words "Caution Radioactive Material";

(7) The name of the procedure;

(8) The radionuclide and chemical form;

(9) The amount of radioactivity and the calibration date and time;

(10) If a liquid, the volume;

(11) If a solid, the number of items or weight;

(12) If a gas, the number of ampules or vials;

(13) Molybdenum 99 content to USP limits; and

(14) The name of the patient or the words "Physician's Use Only" in the absence of a patient name.

(n) When the prescription is for a therapeutic or blood-product radiopharmaceutical, the patient name shall appear on the label. The requirements of this paragraph shall be met when the name of the patient is readily retrievable from the physician upon demand.

(o) The immediate inner container label of a radiopharmaceutical to be dispensed shall be labeled with:

(1) The name of the pharmacy;

(2) The standard radiation symbol;

(3) The words "Caution Radioactive Material";

(4) The identity of the radionuclide;

(5) The chemical form;

(6) The name of the procedure; and

(7) Serial number of the radiopharmaceutical.

(p) When a radiopharmaceutical is dispensed under the authority of an investigational new drug application (IND), the nuclear pharmacy records shall include an investigator's protocol for the preparation of the radiopharmaceutical, and a letter from the manufacturer or sponsor indicating that the physician requesting the radiopharmaceutical is a qualified investigator.

(q) Each nuclear pharmacy shall have a current copy of the United States Pharmacopeia/National Formulary (USP/NF), USP-DI, and a current copy of state and federal rules and regulations governing the safe storage, handling, use, dispensing, transport and disposal of radiopharmaceuticals.

N.H. Admin. Code § Ph 405.03

#6181-B, eff 2-5-96, EXPIRED: 2-5-04

New. #8316, eff 3-26-05

Amended by Volume XXXV Number 18, Filed May 7, 2015 , Proposed by #10812, Effective 4/18/2015, Expires 4/18/2025.