Miss. Code. tit. 30, pt. 3001, art. XXVII

Current through December 10, 2024

Article XXVII - NUCLEAR/RADIOLOGIC PHARMACY

In addition to all other applicable sections of the Mississippi Code of 1972, ARTICLE XXVII of the Mississippi Board of Pharmacy Regulation pertains specifically to nuclear pharmacy and radiopharmaceuticals.

1. DEFINITIONS

A. Authentication of product history means, but is not limited to, identifying the purchasing source, the ultimate fate, and any intermediate handling of any component of a radiopharmaceutical;

B. A nuclear pharmacy is a pharmacy providing the services of storing, compounding, dispensing, labeling or distributing radiopharmaceuticals;

C. Practice of Nuclear Pharmacy means a patient-orient service that embodies the scientific knowledge and professional judgment required to improve and promote health through the assurance of the safe and efficacious use of radiopharmaceuticals and other related drugs.

D. A qualified licensed professional means an individual (such as a physician, nurse, or technologist) who possesses a current state license if applicable, and who has sufficient training and experience to safely handle radiopharmaceuticals as defined by the Mississippi State Department of Health, Division of Radiological Health;

E. A qualified nuclear pharmacist means a currently licensed pharmacist in the state of Mississippi who is certified by the Mississippi State Department of Health, Division of Radiological Health, or who meets the following standards:

(1) Minimum standards of training for "authorized user status" of radioactive materials as defined by Mississippi State Department of Health, Division of Radiological Health;

(2) Completed a minimum of two hundred (200) contact hours of instruction in nuclear pharmacy and the safe handling and the use of radioactive materials from a program approved by the Mississippi Board of Pharmacy, and United States Nuclear Regulatory Commission or Agreement State Agency, with emphasis in the following areas:

(a)Radiation Physics and Instrumentation;

(b)Radiation Protection;

(c)Mathematics of Radioactivity;

(d)Radiation Biology;

(e)Radiopharmaceutical Chemistry.

(3) Attain a minimum of five hundred (500) hours of clinical nuclear pharmacy training under the supervision of a qualified nuclear pharmacist.

F. Nuclear pharmacy technician means a person who works under the supervision of a qualified nuclear pharmacist and who is currently registered with the Mississippi Board of Pharmacy. The duties and responsibilities of these personnel must be consistent with their training and experience.

G. Radiopharmaceutical is any substance defined as a drug in Section 201(g) (1) of the Federal Food, Drug and Cosmetic Act which also contains unstable nuclei which undergo spontaneous disintegration with the emission of nuclear radiation. Radiopharmaceuticals also include any non-radioactive reagent kit or radionuclide generator which is intended to be used in the preparation of radiopharmaceutical doses.

H. Radiopharmaceutical Service means, but shall not be limited to the procurement, storage, handling, compounding, quality control testing, dispensing, delivery, recordkeeping, and disposal of radiopharmaceutical and other drugs as well as quality control procedure, radiological health activities, any consulting activities associated with the use of radiopharmaceuticals, health physics and any other activities required for provision of pharmaceutical care.

I. Radiopharmaceutical Compounding means the preparation, mixing assembling, packaging, or labeling of a reagent kit or biological substance with radioactivity.

J. Radiopharmaceutical quality control means, but is not limited to, the performance of appropriate chemical, biological and physical tests on potential and prepared radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans or animals.

Assurance that variances in the processes are clearly identified, assessed and improved upon if necessary is required for adequate quality control. All quality control procedures must be a set of planned, defined and systematic activities to provide adequate confidence that the product optimally fulfils professional expectations and requirements.

K. The restricted area of a Nuclear Pharmacy is an area with limited access for the purpose of protecting individuals against the undue risks from exposure to radiation and radioactive materials. Generally, the restricted area(s) consists of the compounding/dispensing area, radioactive material storage area and radioactive dose return or breakdown area.

2. NUCLEAR PHARMACY STANDARDS AND EQUIPMENT

Written procedures and policy showing proof of adequate space and equipment for all operations involving radioactive material must be submitted to the Mississippi Board of Pharmacy along with a certified copy of the RADIOACTIVE MATERIAL LICENSE issued by the Mississippi State Department of Health, Division of Radiological Health, before a permit to operate as a Nuclear Pharmacy is issued.

Compliance with applicable radiation protection regulations of the Mississippi State Department of Health, Division of Radiological Health, is further required. Violation of rules and regulations established by the Mississippi State Department of Health, Division of Radiological Health, that directly affects public health and safety, shall serve as prima facie evidence of violation of this ARTICLE.

The restricted area of a nuclear pharmacy shall have at least the following supplies and equipment:

A. Radiation detection and measuring instruments capable of accurately measuring quantities of radioactivity and radiation; and

B. Refrigerator, microscope and a hemacytometer; and

C. Radiochemical fume hood and filter system with suitable air sampling equipment if storing or dispensing volatile substances; and

D. Laminar air flow hood and appropriate supplies to ensure sterile practices for parental solutions; and

E. Syringes, vials, filters and other necessary supplies needed to compound and dispense any oral or sterile parenteral drug product; and

F. Adequate shielding for syringes vials drawing stations and returned dose storage area: and

G.Materials needed for decontamination; and

H. All supplies needed to perform quality control testing; and

I. Appropriate shielding for the transportation of D. O. T. approved outer transport containers; and

J. Required labels and other supplies for proper shipment of radioactive material.

A pharmacy exclusively handling radiopharmaceuticals may be exempt from the general requirements of conventional pharmacies as regards to equipment and inventory.

3. OPERATION OF A NUCLEAR PHARMACY

A. Nuclear Pharmacy License. A license to operate a pharmacy providing radiopharmaceutical services shall only be issued to a qualified nuclear pharmacist. All personnel performing tasks in the preparation and distribution of radioactive drugs shall be under the direct supervision of a qualified nuclear pharmacist. A qualified nuclear pharmacist shall be responsible for all operations of the pharmacy.

B. Nuclear pharmacies shall have adequate space and equipment, commensurate with the scope of services required and provided.

C. The nuclear pharmacy restricted area shall be secured from unobserved entry and/or unauthorized personnel.

D. Nuclear pharmacies shall maintain complete and accurate records of acquisition, inventory, and disposition of all radioactive drugs and other radioactive materials, in accordance with guidelines established by the Mississippi State Department of Health, Division of Radiological Health.

E. All pharmacies handling radiopharmaceuticals shall provide a radioactive storage and product decay area in accordance with guidelines established by the Mississippi State Department of Health, Division of Radiological Health.

F. Radiopharmaceuticals are to be dispensed only upon receipt of a prescription drug order, from a licensed practitioner or his agent. Validation that he is authorized to possess, use or administer radiopharmaceuticals is required.

G. Nuclear pharmacies shall, in addition to this ARTICLE XXVII and the Mississippi State Department of Health, Division of Radiological Health's applicable regulations, comply with any applicable requirements of other governing agencies regarding its daily operations and the disposal of any biohazardous medical waste.

4. DISPENSING OF RADIOPHARMACEUTICALS

Radiopharmaceuticals shall be dispensed/transferred only to a licensed practitioner authorized by the Nuclear Regulatory Commission and/or the Mississippi State Department of Health, Division of Radiological Health to possess, use and administer such drug. A radiopharmaceutical shall be dispensed for medical use only upon receipt of a prescription or medication order from such authorized practitioner. Otherwise, a radiopharmaceutical may be transferred to a person who is authorized by federal or state law to possess and use such drug for non-medical applications. All prescriptions/orders shall be readily retrievable if requested by any governing agency.

A nuclear pharmacy, upon receiving an oral prescription order for a radiopharmaceutical, shall have the prescription order reduced to writing or recorded in a data processing system, which the written or electronic record shall contain at least the following:

A. The name of the institution and prescriber or if applicable the prescriber's agent;

B. The date of dispensing and the calibration time of the radiopharmaceutical;

C. The name of the procedure;

D. The name of the radiopharmaceutical;

E. The activity of the dose or quantity of the radiopharmaceutical;

F. The serial number assigned to the order for the radiopharmaceutical;

G. Any specific instructions; and

H. The initials of the pharmacist who dispensed the order.

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

The immediate outer container transportation shield of a radiopharmaceutical to be dispensed shall be labeled with:

A. The name and address of the pharmacy and prescriber;

B. Activity dispensed, expiration date and time, calibration time, serial number and date of dispensing;

C. The standard radiation symbol and the words "Caution Radioactive Material";

D. The name of the procedure and the radiopharmaceutical, including pharmacy oot number associated with dose;

E. If a liquid, the volume, if a gas, the number of ampules or vials and if a solid, the number of items or weight;

F. Molybdenum 99 content to USP limits (0.15 mCi Mo-99 per 1.0 mCi Tc 99m at time of administration or expiration); and

G. The name of the patient or the words "per physician order" in the absence of a patients name.

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

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

A. Identity of the radiopharmaceutical and the serial number;

B. The standard radiation symbol and the words "Caution Radioactive Material";

C. The chemical form; and

D. The name of the procedure and date dispensed.

For a radiopharmaceutical intended for a specific patient, the immediate inner container shall be labeled with:

A. The standard radiation symbol and the words, "Caution - Radioactive Material";

B. The prescription number and name of patient;

C. Identity and activity or quantity, of the radiopharmaceutical.

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, a copy of the Institutional Review Board approval form or letter, and a letter from the manufacturer (sponsor) indicating that the physician requesting the radiopharmaceutical is a qualified investigator.

Miss. Code. tit. 30, pt. 3001, art. XXVII