Chapter 05. Pharmacy Security
Regulation .01 Definitions.LinkCopy Citation
A.
In this chapter, the following terms have the meanings indicated.
B.
Terms Defined.
(1)
“Emergency” means an event such as a fire, water leak, electrical failure, public disaster, or catastrophe which may impact the prescription area.
(2)
“Means of access” means the manner of entry into the secure prescription area.
(3)
“Prescription area” means the portion of an establishment for which a pharmacy permit has been issued which contains:
(a)
Patient records;
(b)
Prescription devices; and
(c)
Prescription drugs.
Regulation .02 Prescription Area.LinkCopy Citation
A.
The pharmacy permit holder shall:
(1)
Ensure that the prescription area:
(a)
Maintains temperature and ventilation at levels that do not affect the prescription drugs or devices stored in the area; and
(b)
Permits reasonable communication between the pharmacist and the public when the pharmacy is open;
(2)
Provide a means of securing the prescription area;
(3)
Prevent an individual from being in the prescription area unless a pharmacist is immediately available on the premises to provide pharmacy services;
(4)
Monitor unauthorized or emergency entry after the prescription area has been secured by the pharmacist; and
(5)
Prevent unauthorized entry when the prescription area is closed during a period that the rest of the establishment is open.
B.
The pharmacist shall:
(1)
Secure the prescription area and its contents in order that the pharmacy permit holder or the pharmacy permit holder's agent may:
(a)
Monitor unauthorized or emergency entry after the prescription area has been secured by the pharmacist; and
(b)
Prevent unauthorized entry when the prescription area is closed during a period that the rest of the establishment is open;
(2)
Have sole possession of a means of access to the pharmacy, except in emergencies; and
(3)
Establish a means of access for use in an emergency when the pharmacist is not available to access the prescription area.
C.
Security.
(1)
A pharmacy shall be secure from unauthorized entry as follows:
(a)
Access from outside the premises shall be:
(i)
Kept to a minimum; and
(ii)
Well controlled;
(b)
The outside perimeter of the premises shall be well lit; and
(c)
Entry into areas where prescription drugs or devices and patient records are stored shall be limited to authorized personnel.
(2)
A pharmacy shall be equipped with:
(a)
An alarm system to detect entry after hours;
(b)
A security system that provides protection against theft and diversion;
(c)
Appropriate software to facilitate the identification of evidence of tampering with computers or electronic records;
(d)
An inventory management and control system that protects against, detects, and documents any instances of theft, diversion, or counterfeiting;
(e)
A security system to protect the integrity and confidentiality of data and documents limited to authorized personnel; and
(f)
A means to make the data and documentation required under this section readily available to the Board, an agent of the Board, the Division of Drug Control, or federal and other State law enforcement officials.
Regulation .03 Pharmacy Operation.LinkCopy Citation
A.
A pharmacist shall be immediately available on the premises to provide pharmacy services at all times the pharmacy is in operation.
B.
If the prescription area is not open the same hours as the establishment, the pharmacy permit holder shall prominently display signs indicating the business hours of the prescription area.
Regulation .04 Records.LinkCopy Citation
A.
A pharmacy permit holder shall:
(1)
Prevent unauthorized disclosure or loss by securing all patient records;
(2)
Designate personnel with authorized access to computerized patient records; and
(3)
Maintain current computerized records in a manner which permits reconstruction within 48 hours, except:
(a)
In an emergency as defined in Regulation .01 of this chapter, or
(b)
With the prior approval of the Board.
B.
A pharmacy permit holder may store patient records away from the prescription area in a manner that prevents unauthorized disclosure or loss.
Regulation .05 Security Responsibility.LinkCopy Citation
A.
The pharmacy permit holder is responsible for ensuring that pharmacists, employees, and others who enter the pharmacy:
(1)
Know and abide by the requirements of this chapter;
(2)
Maintain those measures necessary to ensure this chapter’s enforcement;
(3)
Report theft or significant loss of controlled dangerous substances to the:
(a)
Board;
(b)
Local police;
(c)
Office of Controlled Substances Administration; and
(d)
U.S. Drug Enforcement Administration; and
(4)
Report theft of non-controlled prescription drugs or devices to the Board.
B.
In determining whether a loss is significant pursuant to §A(3) of this regulation, the pharmacy permit holder shall consider at least the following factors:
(1)
The actual quantity of controlled dangerous substances lost in relation to the type of business;
(2)
The specific controlled dangerous substances lost;
(3)
Whether the loss of the controlled dangerous substances can be associated with access to those controlled dangerous substances by specific individuals, or whether the loss can be attributed to unique activities that may take place involving controlled dangerous substances;
(4)
A pattern of losses over a specific time period, whether the losses appear to be random, and the results of efforts taken to resolve the losses;
(5)
Whether the specific controlled dangerous substances are likely candidates for diversion, if known; and
(6)
Local trends and other indicators of the diversion potential of the missing controlled dangerous substances, if known.
Chapter annotations
Authority: Health Occupations Article, §12-205, Annotated Code of Maryland
History: Effective date: July 25, 1980 (7:15 Md. R. 1425)
History: Regulation .02C adopted effective February 19, 1990 (17:3 Md. R. 298)
History: Chapter, Security of a Pharmacy Facility, repealed and new chapter, Pharmacy Security, adopted effective November 1, 1999 (26:22 Md. R. 1692)
History: Regulation .02C adopted effective July 1, 2010 (37:10 Md. R. 722)
History: Regulation .05 amended effective July 1, 2010 (37:10 Md. R. 722); May 20, 2019 (46:10 Md. R. 489)