Code of Massachusetts Regulations, Title 247 CMR 13.00, Section 13.05 - General Requirements for Nuclear Pharmacies | Code of Massachusetts Regulations

(1) A nuclear pharmacy registered pursuant to 247 CMR 13.00 shall comply with all applicable laws, regulations, and guidelines of the United States Nuclear Regulatory Commission, the United States Food and Drug Administration, and other appropriate federal and state agencies.

(2) No person other than a qualified nuclear pharmacist shall be employed by a nuclear pharmacy to direct and manage the pharmacy.

(3) Only designated qualified nuclear pharmacists shall conduct the radio pharmaceutical activities of a nuclear pharmacy, and at least one qualified nuclear pharmacist shall be in personal attendance at the pharmacy at all times.

(4) A nuclear pharmacy shall not dispense those radio pharmaceuticals which do not comply with acceptable professional standards of radiopharmaceutical quality assurance.

(5) A nuclear pharmacy shall maintain in readily retrievable form for at least three years detailed records of the acquisition and disposition of all radiopharmaceuticals. These records shall be available to the Board or its agents for inspection upon request.

(6) A nuclear pharmacy shall not prepare, compound, or dispense radiopharmaceutical drugs except upon a valid prescription from an authorized practitioner. In order to be valid, a prescription for radiopharmaceutical drugs shall contain the following information:

(a) the name, address, registration number and, in the case of a written prescription, the signature of the practitioner;

(b) the date of the prescription;

(c) the name, dosage unit, and strength per dosage unit of the radiopharmaceutical drug;

(d) the name and address of the patient; if the name of the patient is unknown at the time the prescription is received, the nuclear pharmacy shall obtain the name and address of the patient within 72 hours after dispensing the radiopharmaceutical drug; the address of the facility where the patient is being treated will be sufficient if his or her residential address is unavailable; and

(e) any specific instructions required.

(7) A nuclear pharmacy shall assign a serial number to each radiopharmaceutical drug it dispenses.

(8) A nuclear pharmacist shall, upon receiving an oral prescription for a radiopharmaceutical drug from a practitioner or his or her expressly authorized representative, immediately reduce such prescription to writing on a prescription form, record on it the same information required under 247 CMR 13.05(6), and assign a serial number to such prescription.

(9) In the event a prescribed radiopharmaceutical drug is not administered, it shall be returned to the nuclear pharmacy to be disposed of in accordance with the requirements established by the Nuclear Regulatory Commission and the nuclear pharmacy shall note on the prescription form, or shall record on a readily retrievable record form, that the radiopharmaceutical drug has been returned and shall state the amount of the radiopharmaceutical drug that has been returned. The nuclear pharmacy shall comply with all NRC regulations regarding the return and disposal of radioactive materials.

(10) A nuclear pharmacy may, with proper record-keeping, transfer to authorized persons radioactive materials or side-products which are not intended for medicinal use.

(11)

(a) Radiopharmaceuticals may be dispensed in bulk amounts necessary to activate the single unit doses. The bulk radioactivity shall be supplied no more than once in a 12-hour period. If an emergency radiopharmaceutical is used, the nuclear pharmacy shall, within 72 hours, obtain a written or oral prescription for the radiopharmaceutical which shall contain all the information included in 247 CMR 13.04(5). If the bulk radioactivity is not used, the nuclear pharmacy shall obtain and record a written or oral verification to that effect from the authorized practitioner to whom it was dispensed.

(b) A nuclear pharmacy shall maintain records on all emergency supplies it dispenses as set out in 247 CMR 13.04(11)(a). The records shall include the names of the authorized practitioner and the institution within which he is or she is practicing, the amounts of non-radioactive material and radioactive material supplied, the dates supplied, the dates the radiopharmaceutical was administered, and the prescription serial number for each dose that was administered. The nuclear pharmacist's records shall also contain the authorized practitioner's written or oral verification when the bulk radioactivity is not used. These records shall be made available for inspection by the Board or its agents upon request.

(12) In addition to any other labeling required by federal, state, or local laws or regulations, a registered nuclear pharmacy which dispenses radiopharmaceuticals shall place each such pharmaceutical in an outer container and affix to said container alabelbearing the following information:

(a) the standard radiation symbol;

(b) the words "Caution - Radioactive Material";

(c) the name of the radionuclide;

(d) the chemical form or common name;

(e) the amount of radioactive material, stated in millicuries or microcuries, or in SI units (becquerels) at the time of calibration;

(f) if a liquid, the volume in cubic centimeters or milliliters;

(g) auxiliary warning labels, if any, as needed; and

(h) the expiration date or time.

(13) In the case of investigational radioactive drugs, the nuclear pharmacy's records shall include an investigator's protocol for the preparation of radioactive drugs, a copy of the Human Use Committee Approval, a copy of the approved patient consent form, and a letter from the manufacturer - "sponsor" indicating that the physician requesting the radioactive drug is a qualified investigator.

(14) The premises of a nuclear pharmacy shall at all times be kept in a clean and sanitary manner.

(15) A nuclear pharmacy shall, in legible letters not less than one inch high, conspicuously display the name of the director of pharmacy services on the premises.

(16) A nuclear pharmacy shall have a qualified nuclear pharmacist on the premises during the entire time when said pharmacy is open for business.

(17) A nuclear pharmacy shall keep posted and displayed in a conspicuous place its permit and the certificate of personal registration to practice pharmacy of each registered pharmacist who is employed on a full-time basis by the pharmacy.

(18) A nuclear pharmacy shall in advance of any move to a new location submit to the Board an application for a new permit and payment of the appropriate fees.

(19) Any nuclear pharmacy which is being established, remodeled, or relocated must first submit to the Board for review and approval copies of its structural plans.

(20) A nuclear pharmacy which has moved to a new location shall not operate in said location until said nuclear pharmacy has been approved by the Board and until it has received from the Board a new permit to manage and operate a nuclear pharmacy and a new controlled substances registration.

(21) Each nuclear pharmacy shall, within ten days of the commencement of employment of any pharmacist, or within ten days of the termination of employment of any pharmacist, report to the Board such employment or termination of employment. Such reports may be made upon forms available from the Board.

(22) A nuclear pharmacy shall maintain adequate security measures which are consistent with federal regulations and with the requirements of the Board.

(23) A nuclear pharmacy shall not perform any pharmacy functions other than the dispensing of radiopharmaceutical drug products; it shall not perform the functions of, or operate as, a retail pharmacy or institutional pharmacy.

(24) Only a nuclear pharmacy shall keep in stock or handle radiopharmaceuticals.

(25) No nuclear pharmacy shall require or permit the same nuclear pharmacist to remain on duty for more than 12 hours per day.

(26) A nuclear pharmacy shall be exempt from the following regulations of the Board:

(a) 247 CMR 6.01;

(b) 247 CMR 6.02;

(c) 247 CMR 6.08;

(d) 247 CMR 9.01(12), (15) and (16); and

(e) 247 CMR 9.04(4) and (6).