D.C. Mun. Regs. tit. 22, r. 22-B1910

Current through Register Vol. 71, No. 49, December 6, 2024
Rule 22-B1910 - SECURITY AND SAFEGUARDS AGAINST DRUG DIVERSION
1910.1

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

1910.2

A 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) Beginning six (6) months after the effective date of these regulations, includes a video surveillance system meeting the requirements set forth in § 1910.3 of this chapter;
(d) Has an auxiliary source of power; and
(e) Is in good repair and operating order at all times.
1910.3

Beginning six (6) months after the effective date of these regulations, all pharmacies shall be required to operate and maintain in good working order a video surveillance system on the premises in compliance with the following:

(a) The video surveillance system shall be continuously operated twenty-four (24) hours, seven (7) days a week and shall display an accurate date and time stamp on all video recordings;
(b) The video surveillance system shall store without recording over, at a minimum, the current day and previous thirty (30) days of video surveillance recording;
(c) The video surveillance system shall record all pharmacy-related operations, including drug storage, dispensing, compounding, and patient consultations areas, but may exclude private patient areas and areas used for administering medications or immunizations;
(d) The video surveillance system shall record all automated dispensing machines (ADM) utilized in institutional pharmacies, but may exclude private patient areas;
(e) The video surveillance recordings for the current day and previous thirty (30) days shall be viewable upon request by a Department investigator or inspector;
(f) The video surveillance system shall be capable of producing, at a minimum, a digital storage device of the current day and previous thirty (30) days of recording in a standard format that is viewable on any Windows PC and that includes any required device or software necessary for viewing;
(g) The video surveillance recording shall be provided to the Department within seventy-two (72) hours of a request by a Department investigator or inspector; and
(h) The video surveillance system shall be maintained in good working order at all times and tested monthly for proper retrieval functionality. The pharmacy shall retain all documentation regarding the testing of its video surveillance system, and present that documentation upon request to a Department inspector or investigator. The pharmacy shall report any malfunctioning or inoperability of the system to the Department within seventy-two (72) hours of discovering the issue.
1910.4

The 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.

1910.5

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

1910.6

If 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.

1910.7

Each 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.

1910.8

A 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.

1910.9

Access 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.
1910.10

The 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.

D.C. Mun. Regs. tit. 22, r. 22-B1910

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); amended by Final Rulemaking published at 69 DCR 2763 (4/1/2022)