Be it enacted by the Senate and House of Representatives
in General Court assembled, and by the authority of the same,
SECTION 1. Section 1 of chapter 94C of the General Laws, as appearing in the 1984 Official Edition, is hereby amended by inserting, after the definition of "Narcotic drug" the following definition:-
"Nuclear pharmacy", a facility under the direction or supervision of a registered pharmacist which is authorized by the board of registration in pharmacy to dispense radiopharmaceutical drugs.
SECTION 2. Said section 1 of said chapter 94C, as so appearing, is hereby further amended by inserting after the definition of "Production" the following definition:-
"Radiopharmaceutical drug", any drug which is radioactive as defined in the Federal Food, Drug and Cosmetic Act.
SECTION 3. Said chapter 94C, as so appearing, is hereby further amended by inserting after section 20 the following section:-
Section 20A. Notwithstanding any other provisions of this chapter, a prescription for a radiopharmaceutical drug shall be dispensed only to an individual authorized by the nuclear regulatory commission to possess and administer such drug.
Upon receiving an oral prescription for a radiopharmaceutical drug from an authorized practitioner, the nuclear pharmacist shall immediately reduce the prescription to writing and shall record the name, address and registration number of the practitioner and the name of any expressly authorized representative, the date of the prescription, the name and the dose of the radiopharmaceutical drug, the serial number assigned to the prescription by the dispensing nuclear pharmacy, the name of said nuclear pharmacy, the name and address of the patient and any specific instructions required. If the radiopharmaceutical drug is not administered, it shall be returned to the nuclear pharmacy to be disposed of in accordance with requirements established by the nuclear regulatory commission and any applicable law and the nuclear pharmacist shall note on the prescription form the amount of the radiopharmaceutical drug that has been returned and disposed of as required.
SECTION 4. Chapter 112 of the General Laws is hereby amended by inserting after section 39A the following section:-
Section 39B. The board may, upon application, made in such manner and form as it shall determine, register an establishment for transacting business as a nuclear pharmacy as defined in section one of chapter ninety-four C. A nuclear pharmacy shall be independent of and separate from any business and shall not perform any pharmacy functions other than the dispensing of radiopharmaceutical drug products. The board shall issue a permit to such person as it deems qualified to conduct such pharmacy; provided, however, that the board may deny such registration and may refuse to issue such permit if, in its discretion, it determines that such pharmacy would be inconsistent with or opposed to the best interest of the public health, welfare and safety. No such registration shall be made or permit issued in the case of a corporation unless it shall appear to the satisfaction of the board that the management of such nuclear pharmacy is in the hands of a registered pharmacist. Such permit shall expire on December thirty-first of each uneven numbered year following the date of its issue, and the fee therefor shall be determined annually by the commissioner of administration and finance under the provisions of section three B of chapter seven. The board shall, within one hundred and fifty days after the filing of an application, render a final decision denying or allowing registration. Failure to render such decision, except when failure to act is caused by the delay of the applicant, shall constitute an approval of the application and the permit shall be issued.
The board, in consultation with the department of public health shall promulgate regulations pertaining to the operation of nuclear pharmacies in the commonwealth. Such regulations may include procedures governing the dispensing of radiopharmaceutical drugs when the name of a patient to whom the drug is to be administered is not known at the time a prescription order is received, provided that such regulations shall allow a nuclear pharmacist up to seventy-two hours after dispensing a radiopharmaceutical drug to determine the patient's name and record such information on the appropriate form.
SECTION 5. Section 40 of said chapter 112, as appearing in the 1984 Official Edition, is hereby amended by striking out, in line 2, the words "or thirty-nine A" and inserting in place thereof the words:- , thirty-nine A or thirty-nine B.
SECTION 6. The board of registration in pharmacy, in consultation with the department of public health, shall promulgate regulations for the operation of nuclear pharmacies required under section four of this act within one hundred and eighty days of the effective date of this act.