Ala. Admin. Code r. 680-X-2-.11

Current through Register Vol. 42, No. 8, May 31, 2024
Section 680-X-2-.11 - Pharmacy Keys Or Other Controlled Access Device Or Method
(1) Any pharmacy doing business within the State of Alabama must be physically enclosed, secured and locked when not open for business, except in the temporary absence of the pharmacist on duty as provided for in § 34-23-70(a). Title 34, Chapter 23, Code of Ala. 1975. At all times, registered Pharmacists designated by the licensee must have all keys or other controlled access device or method in their possession. The owner of the pharmacy may designate one (1) unregistered person to have a key or other controlled access device or method to the pharmacy and still be considered to be in their possession. The Supervising Pharmacist must agree to this arrangement. The enclosed and secured area must encompass all drugs, products, and devices, the character of which require dispensing or sale by a registered Pharmacist, and include store rooms used for receiving or storing these items. The permit holder (owner) must execute a signed agreement with the individual in possession of a key or other controlled access device or method to the pharmacy and must submit a copy to the Board of Pharmacy for approval prior to issuing a key or other controlled access device or method to any person that does not hold an active pharmacist license in the State of Alabama. Forms for this purpose may be obtained from the Board of Pharmacy. Further, if the municipality or other government authority in the jurisdiction where a pharmacy is located requires compliance with a Fire Code that mandates making a key or other controlled access device or method to the premises available to First Responders, the permit holder (owner) must execute a signed agreement with the highest ranking official of the agency that wants access to the key or other controlled access device or method and submit a copy of the Board of Pharmacy for approval prior to providing access to a key or other controlled access device or method; the Knox Box or other system for accessing the key or other controlled access device or method must have a working tamper protection system that is connected to an alarm system that will notify the permit holder (owner) or the Supervising Pharmacist if an attempt is made to remove the key or other controlled access device or method by unauthorized persons.
(2) Where the Pharmacist does not have access to the prescription department by other entrances after normal operating hours of the entire store the owner shall have an action plan that allows the pharmacist to gain access in case of an emergency.

Ala. Admin. Code r. 680-X-2-.11

Filed June 1, 1982. Amended: Filed January 30, 2012; effective March 5, 2012.

Author: Herb Hobo, R.Ph., Secretary

Statutory Authority:Code of Ala. 1975, § 34-23-92.