3.6 Pharmacy Facility Security, Equipment & Reference Requirements

Pharmacy Facility Security, Equipment & Reference Requirements

To ensure the safe compounding, dispensing, and storage of pharmaceuticals, the Georgia Board of Pharmacy mandates that all licensed pharmacies adhere to strict physical, security, and equipment standards. These requirements are designed to prevent diversion, maintain drug integrity, and provide pharmacists with the necessary tools and information to practice safely. Before a permit is issued or a change of location is approved, a Board agent will inspect the facility to verify compliance with these rigorous standards.

Physical Facility Requirements

The physical space of the pharmacy must be designed to promote a sanitary and organized workflow.

Space and Layout

• Minimum Square Footage: In Georgia, the space devoted strictly to the pharmacy (the prescription department) must have a minimum of 150 square feet of floor space. This ensures adequate room for personnel to move and work safely without overcrowding.
• Work Counters: There must be sufficient counter space for compounding and dispensing. The Board requires an unobstructed work space that is kept clean and organized.
• Aisle Space: The clear floor area in the dispensing area must be wide enough to allow personnel to pass each other safely.

Plumbing and Sanitation

• The Pharmacy Sink: A critical requirement for any pharmacy is a dedicated sink within the prescription department. This sink must have both hot and cold running water. It must be easily accessible to the compounding area and is essential for handwashing and cleaning equipment.
• Cleanliness: The pharmacy must be maintained in a clean, sanitary, and orderly condition at all times.

Storage and Refrigeration

• Refrigeration: The pharmacy must have a refrigerator that is dedicated solely to the storage of drugs requiring cold storage (e.g., insulin, vaccines). The refrigerator must be equipped with a reliable thermometer to ensure temperatures are maintained within the required range (typically 36°F to 46°F or 2°C to 8°C).
• No Food: Storing food or beverages in the drug refrigerator is strictly prohibited to prevent contamination.
• Shelving: Adequate shelving and storage facilities must be provided to keep drugs off the floor and properly organized.

Security Requirements

Securing the pharmacy department against unauthorized entry and the diversion of dangerous drugs and controlled substances is a paramount responsibility of the Pharmacist-in-Charge.

Physical Barriers

When a pharmacist is not on duty and physically present in the prescription department, the area must be secured.

• Floor-to-Ceiling Enclosure: If the pharmacy is located within a larger mercantile establishment (like a grocery store or big-box retailer) that remains open when the pharmacy is closed, the pharmacy department must be completely enclosed. This barrier must extend from the floor to the ceiling, or be constructed in a manner approved by the Board that prevents unauthorized access.
• Locking Mechanisms: The doors to the pharmacy department must be securely locked when closed. Only a pharmacist may have the key or combination to the prescription department.

Alarm Systems

While not explicitly mandated by every state, it is the standard of practice and strongly recommended (and often required by insurance or corporate policy) that pharmacies utilize electronic security systems and cameras to monitor the premises and deter theft.

Minimum Equipment Requirements

To ensure that pharmacists can accurately compound and dispense medications, the Board requires every retail pharmacy to maintain a specific set of minimum equipment. This ensures that the pharmacy is fully functional and not just a distribution point for pre-packaged pills.

Required Equipment List

The standard minimum equipment list includes, but is not limited to:

1. Class A Prescription Balance: Or an electronic balance of equivalent or greater accuracy.
2. Weights: An appropriate set of accurate metric weights (if using a mechanical balance).
3. Graduates: Assorted sizes of graduated cylinders (glass or plastic) capable of measuring volumes accurately.
4. Mortars and Pestles: At least two mortars and pestles of appropriate size and material (e.g., glass, Wedgwood, or porcelain).
5. Spatulas: At least two spatulas of appropriate sizes (e.g., stainless steel and non-metallic).
6. Ointment Slab: A glass ointment slab or pill tile, or parchment paper pads, for compounding topical preparations.
7. Counting Trays: At least one pill counting tray. (Best practice is to have a separate tray for counting penicillin or sulfa drugs).
8. Stirring Rods: Glass or plastic stirring rods.
9. Labels and Packaging: An adequate supply of child-resistant containers, prescription labels, and auxiliary labels.

Note: Pharmacies that engage in specialized compounding (e.g., sterile compounding) will have additional, highly specific equipment requirements (like laminar flow hoods) mandated by USP chapters <795> and <797>.

Reference Material Requirements

A pharmacist cannot rely solely on memory; access to current, authoritative information is a legal requirement.

The Pharmacy Library

Every pharmacy must maintain a reference library. While these used to be large printed volumes, modern regulations allow these references to be maintained electronically (e.g., via a computer terminal in the pharmacy), provided they are immediately accessible to the staff.

The required references typically include:

1. Current Laws and Rules: A copy of the current Georgia Pharmacy Practice Act, the Georgia Controlled Substances Act, and the rules of the Georgia Board of Pharmacy.
2. Federal Regulations: A copy of the current DEA regulations pertaining to controlled substances.
3. Drug Interactions: A current reference detailing drug-drug and drug-food interactions.
4. Patient Counseling: Materials adequate to assist the pharmacist in fulfilling the OBRA '90 patient counseling requirements.
5. Poison Control: The telephone number of the regional Poison Control Center must be conspicuously posted within the prescription department.

By enforcing these facility, equipment, and reference standards, the Georgia Board of Pharmacy ensures that every licensed pharmacy is physically capable of providing safe and effective pharmaceutical care.