Section R4-23-675. Limited-service Sterile Pharmaceutical Products Pharmacy

A.      The limited-service pharmacy permittee or the pharmacist-in- charge shall ensure that the limited-service sterile pharmaceu- tical products pharmacy complies with the standards for area, personnel, security, sanitation, equipment, sterile pharmaceuti- cal products, and limited-service pharmacies established in R4-23-608, R4-23-609, R4-23-610, R4-23-611, R4-23-612, R4-23-670, and R4-23-671.

B.       The pharmacist-in-charge of a limited-service sterile pharma- ceutical products pharmacy shall authorize only pharmacists, interns, compliance officers, peace officers acting in their offi- cial capacities, pharmacy technicians, pharmacy technician trainees, support personnel, and other designated personnel to be in the limited-service sterile pharmaceutical products phar- macy.

C.      The pharmacist-in-charge of a limited-service sterile pharma- ceutical products pharmacy shall ensure that prescription med-

ication is delivered to the patient or locked in the dispensing area when a pharmacist is not present in the pharmacy.

D.      In addition to the delivery requirements of R4-23-402, the lim- ited-service pharmacy permittee shall, during regular hours of operation, but not less than a minimum 40 hours per week, provide toll-free telephone service to facilitate communication between patients and a pharmacist who has access to patient records at the limited-service sterile pharmaceutical products pharmacy. The limited-service pharmacy permittee shall dis- close this toll-free number on a label affixed to each container dispensed from the limited-service sterile pharmaceutical products pharmacy.

E.       The limited-service pharmacy permittee or the pharmacist-in- charge shall ensure development, implementation, review and revision in the same manner described in R4-23-671(E) and compliance with policies and procedures for pharmacy opera- tions, including pharmaceutical product  compounding, dis- pensing, and distribution, that comply with the requirements of R4-23-402, R4-23-410, R4-23-670, and R4-23-671.

F.       The non-dispensing roles of the pharmacist may include chart reviews, audits, drug therapy monitoring, committee participa- tion, drug information, and in-service training of pharmacy and other health professionals.

Historical Note

New Section made by final rulemaking at 10 A.A.R. 3391, effective October 2, 2004 (Supp. 04-3). Amended by final rulemaking at 12 A.A.R. 3032, effective October 1, 2006 (Supp. 06-3). Amended by final rulemaking at

119 A.A.R. 2895, effective November 10, 2013 (Supp.

R4-23-676. Reserved   through       R4-23-680. R4-23-681. Reserved General   Requirements   for      Limited-service

13-3).

Nuclear Pharmacy

A.      To be an authorized nuclear pharmacist, a pharmacist shall:

1.        Hold a current pharmacist license issued by the Board; and

2.        Be certified as a nuclear pharmacist by:

a.         The Board of Pharmaceutical Specialties, or

b.        A similar group recognized by the Arizona State Board of Pharmacy; or

3.        Satisfy each of the following requirements:

a.         Meet minimal standards of training for status as an authorized user of radioactive material, as specified by the Arizona Radiation Regulatory Agency and the United States Nuclear Regulatory Commission;

b.        Submit certification of completion of a Board- approved nuclear pharmacy training program or other training program recognized by the Arizona Radiation Regulatory Agency, with 200 hours of didactic training in the following areas:

i.         Radiation physics and instrumentation,

ii.        Radiation protection,

iii.      Mathematics pertaining to the use and measure- ment of radioactivity,

iv.       Radiation biology, and

v.        Radiopharmaceutical chemistry;

c.         Submit evidence of a minimum of 500 hours of clin- ical/practical nuclear pharmacy training under the supervision of an authorized nuclear pharmacist in the following areas:

i.         Procuring radioactive materials;

ii.        Compounding radiopharmaceuticals;

iii.      Performing routine quality control procedures;

iv.       Dispensing radiopharmaceuticals;

v.        Distributing radiopharmaceuticals;

vi.       Implementing basic radiation protection proce- dures; and

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

d.        Submit written certification, signed by a preceptor who is an authorized nuclear pharmacist, that the above training was satisfactorily completed.

B.       Radiopharmaceuticals are prescription-only drugs that require specialized techniques in their handling and testing, to obtain optimum results and minimize hazards.

1.        A person shall not sell, barter, or otherwise dispose of, or be in possession of any radiopharmaceutical except under the conditions detailed in A.R.S. § 32-1929.

2.        A person shall not manufacture, compound, sell, or dis- pense any radiopharmaceutical unless the  person is  a pharmacist or a pharmacy intern acting under the direct supervision of a pharmacist in accordance with A.R.S. § 32-1961 and these rules, with the exception of the follow- ing, if the following are licensed by the Arizona Radia- tion Regulatory Agency to use radiopharmaceuticals in compliance with A.R.S. § 30-673;

a.         A medical practitioner who administers a radiophar- maceutical to the medical practitioner’s patient as provided in A.R.S. § 32-1921(A),

b.        A hospital nuclear medicine department, and

c.         A medical practitioner’s office.

3.        The Board shall cooperate with the Arizona Radiation Regulatory Agency and other interested state and federal agencies, in the enforcement of these rules for the protec- tion of the public. This cooperation  may include exchange of licensing and other information, joint inspec- tions, and other activities where indicated.

C.      In addition to compliance with all the applicable federal and state laws and rules governing drugs, whether radioactive or not, a limited-service nuclear pharmacy permittee shall com- ply with all laws and rules of the Arizona Radiation Regula- tory Agency and the U.S. Nuclear Regulatory Commission, including emergency and safety provisions.

D.      A limited-service nuclear pharmacy permittee shall comply with the education, experience, and licensing requirements of the Arizona Radiation Regulatory Agency.

E.       A limited-service nuclear pharmacy permittee shall ensure that radiopharmaceuticals are transferred only to a person or firm that holds a current Radioactive Materials License issued by the Arizona Radiation Regulatory Agency.

Historical Note

Adopted effective December 3, 1974 (Supp. 75-1).

Amended subsections (A), (C) and (D) effective Aug. 12, 1988 (Supp. 88-3). Amended effective July 8, 1997

(Supp. 97-3).