Section 22-B1910. SECURITY AND SAFEGUARDS AGAINST DRUG DIVERSION

 

1910.1The security and safeguards requirements of this section shall apply to all pharmacies, unless otherwise exempted by this chapter or the Director.

 

1910.2A pharmacy shall have a security alarm system which:

 

(a)Detects unauthorized entry into the premises;

 

(b)Provides zone protection for the drug storage, compounding, and dispensing areas;

 

(c)Has an auxiliary source of power; and

 

(d)Is in good repair and operating order at all times.

 

1910.3The prescription drug compounding and dispensing area and the drug storage area shall be separately enclosed and secured in such a manner as to prevent diversion and authorized access.

 

1910.4Any controlled substance stored outside of the prescription drug compounding and dispensing area shall be kept in a locked storage area.

 

1910.5If only a designated area of an establishment is used as a pharmacy, the pharmacy area shall be securely enclosed and capable of being locked and equipped with an alarm system and inaccessible from the rest of the establishment.

 

1910.6Each pharmacist, while on duty, shall be responsible for the security of the pharmacy, including provisions for effective control against theft or diversion of drugs or devices.

 

1910.7A pharmacy shall be secured by either a physical barrier with a suitable lock, or by an electronic barrier to detect entry, and protected by an alarm at all times while a pharmacist is not on duty.

 

1910.8Access to the prescription drug compounding, dispensing, and storage areas shall be restricted to:

 

(a)Pharmacists employed by the pharmacy;

 

(b)Ancillary persons who require entry for the purpose of discharging a job related duty in the presence of a pharmacist; and

 

(c)Persons legally entitled to engage in inspections or enforcement duties.

 

1910.9The following drugs, medical devices, and medical supplies shall not be kept or displayed in an area that is accessible to the public:

 

(a)Prescription or legend drugs and medical devices;

 

(b)Devices that may be used in the administration of controlled substances;

 

(c)Over-the-counter medicine that contains a controlled substance; and

 

(d)Over-the-counter medicines that have been identified by the Food and Drug Administration or the Director as having a potential for misuse or abuse.

 

source

Final Rulemaking published at 38 DCR 6734, 6742 (November 8, 1991); as amended by Notice of Final Rulemaking published at 55 DCR 270 (January 11, 2008).