Ariz. Admin. Code § 4-23-682

Current through Register Vol. 30, No. 50, December 13, 2024

Section R4-23-682 - Limited-service Nuclear Pharmacy

A. Before operating a limited-service nuclear pharmacy, a person shall obtain a permit in compliance with A.R.S. §§ 32-1929, 32-1930, and 32-1931, and R4-23-606.

B. A permit to operate a limited-service nuclear pharmacy shall be issued only to a person who is or employs an authorized nuclear pharmacist and holds a current Arizona Radiation Regulatory Agency Radioactive Materials License. A limited-service nuclear pharmacy permittee that fails to maintain a current Arizona Radiation Regulatory Agency Radioactive Materials License shall be immediately suspended pending revocation by the Board. A limited-service nuclear pharmacy permittee shall have copies of Arizona Radiation Regulatory Agency inspection reports available upon request for Board inspection.

1. A limited-service nuclear pharmacy permittee shall designate an authorized nuclear pharmacist as the pharmacist-in-charge. The pharmacist-in-charge shall be responsible to the Board:

a. For the operations of the pharmacy related to the practice of pharmacy and distribution of drugs and devices;

b. For communicating Board directives to the management, pharmacists, interns, and other personnel of the pharmacy; and

c. For the pharmacy's compliance with all federal and state pharmacy laws and rules.

2. An authorized nuclear pharmacist shall directly supervise all personnel performing tasks in the preparation and distribution of radiopharmaceuticals and ancillary drugs.

3. An authorized nuclear pharmacist shall be present whenever the limited-service nuclear pharmacy is open for business.

C. A limited-service nuclear pharmacy permittee shall ensure that the limited-service nuclear pharmacy complies with the standards for personnel, area, security, sanitation, and general requirements in R4-23-608, R4-23-609, R4-23-610, R4-23-611, and R4-23-671.

1. A limited-service nuclear pharmacy shall contain separate areas for:

a. Preparing and dispensing radiopharmaceuticals,

b. Receiving and shipping radiopharmaceuticals,

c. Storing radiopharmaceuticals, and

d. Decaying radioactive waste.

2. The Board may require more than the minimum area in instances where equipment, inventory, personnel, or other factors cause crowding to a degree that interferes with safe pharmacy practice.

D. The pharmacist-in-charge shall designate in writing, by title and specific area, the persons who may have access to particular pharmacy areas.

E. A limited-service nuclear pharmacy permittee shall maintain records of acquisition, inventory, and disposition of radiopharmaceuticals, other radioactive substances, and other drugs in accordance with federal and state statutes and rules.

1. A prescription order, in addition to the requirements in A.R.S. § 32-1968(C) and R4-23-407(A), shall contain:

a. The date and time of calibration of the radiopharmaceutical,

b. The name of the procedure for which the radiopharmaceutical is prescribed, and

c. The words "Physician's Use Only" instead of the name of the patient if the radiopharmaceutical is nontherapeutic or for a nonblood product.

2. The lead container used to store and transport a radio-pharmaceutical shall have a label that, in addition to the requirements in A.R.S. § 32-1968(D), includes:

a. The date and time of calibration of the radiopharmaceutical,

b. The name of the radiopharmaceutical,

c. The molybdenum 99 content to USP limits,

d. The name of the procedure for which the radiopharmaceutical is prescribed,

e. The words "Physician's Use Only" instead of the name of the patient if the radiopharmaceutical is nontherapeutic or for a nonblood product,

f. The words "Caution: Radioactive Material," and

g. The standard radiation symbol.

3. The radiopharmaceutical container shall have a label that includes:

a. The date and time of calibration of the radiopharmaceutical;

b. The name of the patient, recorded before dispensing, if the radiopharmaceutical is therapeutic or for a blood product;

c. The words "Physician's Use Only" instead of the name of the patient if the radiopharmaceutical is nontherapeutic or for a nonblood product;

d. The name of the radiopharmaceutical;

e. The dose of radiopharmaceutical;

f. The serial number;

g. The words "Caution: Radioactive Material"; and

h. The standard radiation symbol.

F. The following minimum requirements are in addition to the requirements of the Arizona Radiation Regulatory Agency, the applicable U.S. Nuclear Regulatory Commission regulations, and the applicable regulations of the federal Food and Drug Administration. A limited-service nuclear pharmacy permittee shall provide:

1. In addition to the minimum pharmacy area requirements in R4-23-609:

a. An area for the storing, compounding, and dispensing of radiopharmaceuticals completely separate from pharmacy areas for nonradioactive drugs;

b. A minimum of 80 sq. ft. for a hot lab and storage area; and

c. A minimum of 300 sq. ft. of compounding and dispensing area;

2. The following equipment:

a. Fume hood, approved by the Arizona Radiation Regulatory Agency;

b. Laminar flow hood;

c. Dose calibrator;

d. Refrigerator;

e. Prescription balance, Class A, and weights or an electronic balance of equal or greater accuracy;

f. Well scintillation counter;

g. Incubator oven;

h. Microscope;

i. An assortment of labels, including prescription labels and cautionary and warning labels;

j. Glassware necessary for compounding and dispensing radiopharmaceuticals as required by the Arizona Radiation Regulatory Agency;

k. Other equipment necessary for radiopharmaceutical quality control for products compounded or dispensed as required by the Arizona Radiation Regulatory Agency;

l. Current antidote and drug interaction information; and

m. Regional poison control phone number prominently displayed in the pharmacy area;

3. Supplies necessary for compounding and dispensing radiopharmaceuticals as required by the Arizona Radiation Regulatory Agency;

4. A professional reference library consisting of a minimum of one current reference or text addressing each of the following subject areas:

a. Therapeutics,

b. Nuclear pharmacy practice, and

c. Imaging;

5. Current editions and supplements of:

a. A.R.S. §§ 30-651 through 30-696 pertaining to the Arizona Radiation Regulatory Agency,

b. Rules of the Arizona Radiation Regulatory Agency,

c. Regulations of the federal Food and Drug Administration pertaining to radioactive drugs,

d. Arizona Pharmacy Act and rules,

e. Arizona Uniform Controlled Substances Act, and

f. Radiological Health Handbook.

G. The pharmacist-in-charge of a limited-service nuclear pharmacy shall prepare, implement, review, and revise in the same manner described in R4-23-671(E) and comply with written policies and procedures for pharmacy operations and drug distribution.

H. The written policies and procedures of a limited-service nuclear pharmacy shall include the following:

1. Prescription orders;

2. Clinical services and drug utilization management including:

a. Drug utilization reviews,

b. Inventory audits,

c. Patient outcome monitoring,

d. Drug information, and

e. Education of pharmacy and other health professionals;

3. Duties and qualifications of professional and support staff;

4. Radioactive material handling, storage, and disposal;

5. Drug product procurement;

6. Drug compounding, dispensing, and storage;

7. Investigational drugs and their protocols;

8. Patient profiles;

9. Quality management procedures for:

a. Adverse drug reaction reports;

b. Drug recall;

c. Expired and beyond-use-date drugs;

d. Medication or dispensing errors;

e. Radiopharmaceutical quality assurance;

f. Radiological health and safety;

g. Drug storage and disposition; and

h. Education of professional staff, support staff, and patients;

10. Recordkeeping;

11. Sanitation;

12. Security;

13. Drug delivery requirements for:

a. Transportation,

b. Security,

c. Radiological health and safety procedures,

d. Temperature and other environmental controls, and

e. Emergency provisions; and

14. Patient education.

Ariz. Admin. Code § R4-23-682

Adopted effective July 8, 1997 (Supp. 97-3). Amended by final rulemaking at 12 A.A.R. 3032, effective October 1, 2006 (Supp. 06-3).