Section R4-23-610. Community Pharmacy Personnel and Security Procedures

A.      Every pharmacy shall have a pharmacist designated as the “pharmacist-in-charge.”

1.        The pharmacist-in-charge shall ensure the communica- tion and compliance of Board directives to the manage- ment, other pharmacists, interns, and technicians of the pharmacy.

2.        The pharmacist-in-charge shall:

a.         Ensure that all pharmacy policies and procedures required under 4 A.A.C. 23 are prepared, imple- mented, and complied with;

b.        Review biennially and, if necessary, revise all phar- macy  policies  and  procedures  required  under  4

A.A.C. 23;

c.         Document the review required under subsection (A)(2)(b);

d.        Ensure that all pharmacy policies and procedures required under 4 A.A.C. 23 are assembled as a writ- ten or electronic manual; and

e.         Make all pharmacy policies and procedures required under 4 A.A.C. 23 available in the pharmacy for employee reference and inspection by the Board or its staff.

B.       Personnel permitted in the pharmacy area of a community pharmacy include pharmacists, graduate interns, pharmacy interns, compliance officers, drug inspectors, peace officers

acting in their official capacity, other persons authorized by law, pharmacy technicians, pharmacy technician trainees, sup- port personnel, and other designated personnel. Pharmacy interns, graduate interns, pharmacy technicians, pharmacy technician trainees, support personnel, and other designated personnel shall be permitted in the pharmacy area only when a pharmacist is on duty, except in an extreme emergency as defined in R4-23-110.

1.        The pharmacist-in-charge shall comply with the mini- mum area requirements as described in R4-23-609 for a community pharmacy and for compounding and dispens- ing counter area.

2.        A pharmacist employed by a pharmacy shall ensure that the pharmacy is physically secure while the pharmacist is on duty.

C.      In a community pharmacy, a pharmacist shall ensure that the pharmacy area, and any additional storage area for drugs that is restricted to access only by a pharmacist is locked when a pharmacist is not present, except in an extreme emergency.

D.      A pharmacist is the only person permitted by the Board to unlock the pharmacy area or any additional storage area for drugs restricted to access only by a pharmacist, except in an extreme emergency.

E.       A pharmacy permittee or pharmacist-in-charge shall ensure that any  prescription-only drugs and  controlled substances received in an area outside the pharmacy area are immediately transferred unopened to the pharmacy area. The pharmacist- in-charge shall ensure that any prescription-only drug and con- trolled substance shipments are opened and marked by phar- macy personnel in the pharmacy area under the supervision of a pharmacist, graduate intern, or pharmacy intern.

F.       A pharmacy permittee or pharmacist-in-charge may provide a small opening or slot through which a written prescription order or prescription medication container to be refilled may be left in the prescription area when the pharmacist is not pres- ent.

G.      A pharmacist shall ensure that prescription medication is not left outside the prescription area or picked up by the patient when the pharmacist is not present by either:

1.        Delivering the prescription medication to the patient, or

2.        Securing the prescription medication inside the locked pharmacy, except when using an automated storage and distribution system that complies with the requirements of R4-23-614.

Historical Note

Former Rules 6.6410, 6.6420, 6.6430, 6.6440, 6.6450,

6.6460, 6.6470, 6.6480, and 6.6490; Amended subsection (F), deleted subsection (I) effective August 9, 1983 (Supp. 83-4). Amended effective May 16, 1990 (Supp.

90-2). Amended effective November 1, 1993 (Supp. 93- 4). Amended effective April 1, 1995; filed with the Secre- tary of State January 31, 1995 (Supp. 95-1). Amended by final rulemaking at 5 A.A.R. 4441, effective November 2,

1999 (Supp. 99-4). Amended by final rulemaking at 10

A.A.R. 4453, effective December 4, 2004 (Supp. 04-4). Amended by final rulemaking at 12 A.A.R. 3032, effec-

tive October 1, 2006 (Supp. 06-3). Amended by final

rulemaking at 13 A.A.R. 2631, effective September 8,

2007 (Supp. 07-3).