Compliance Inspection Report (Page 7 of 11) in pdf

Item

Requirements

YES

N/A

Comment / Observation

No.

Equipment, Facility and Drug Storage, con’t.

A pharmacist shall not dispense or distribute expired, outdated or otherwise substandard drugs or devices or counterfeit

drugs or devices to any person or entity who is not licensed or legally authorized to receive such drugs or devices

(Quarantine area available). (247 CMR 9.01 (10))

There shall be within every pharmacy or pharmacy department a prescription area of not less than 300 square feet to

accommodate the appropriate pharmaceutical equipment, apparatus, and supplies, and to facilitate the proper

preparation and compounding of prescribed medications. This area shall provide for an arrangement and storage of

drugs that is calculated to prevent their accidental misuse. (247 CMR 6.01 (5) (b))

A pharmacy must provide a designated consultation area designed to provide adequate privacy for confidential visual

and auditory patient counseling. The private consultation area must be accessible by a patient from the outside of the

prescription dispensing area without having to traverse a stockroom or the prescription dispensing area. (247 CMR 6.01

(5) (d) (1))

Refrigeration

Pharmacy utilizes either: (a) combination refrigerator/freezer; or (b) a stand alone refrigerator or freezer that has self-

defrosting compartments. (247 CMR 9.01 (1) and (5)) (Board Policy No. 2011-01)

Refrigerators and freezers are maintained within proper range (Refrigeration at 36º to 46ºF/2º to 8ºC; Freezer at-13º to

14ºF/-25º to -10ºC USP recommended range) in accordance with manufacturer recommended medication storage

requirements. (247 CMR 9.01 (1) and (5)) (Board Policy No. 2011-01)

Pharmacy refrigerators and freezers are kept clean, organized, and defrosted. (247 CMR 9.01 (1) and (5)) (Board Policy

No. 2011-01)

Pharmacy utilizes a certified thermometer with an out of range alarm. (247 CMR 9.01 (1) and (5)) (Board Policy No.

2011-01)

Pharmacy utilizing a certified thermometer without an alarm utilizes a daily temperature log. (247 CMR 9.01 (1) and (5))

(Board Policy No. 2011-01)

Action policy and procedure developed to respond to any out of range temperature reading to ensure the integrity of

stored medications. (247 CMR 9.01 (1) and (5)) (Board Policy No. 2011-01)

Refrigerated inventory is organized to allow for proper air flow. No cardboard or solid plastic shelving is utilized (impedes

proper air circulation). (247 CMR 9.01 (1) and (5)) (Board Policy No. 2011-01)

Refrigerators and freezers provide adequate space for amount and type of medications stored by the pharmacy. No

medications are overstocked. (247 CMR 9.01 (1) and (5)) (Board Policy No. 2011-01)

Policy developed that no food or beverage products may be stored in the refrigerators or freezers and monitored.

(247 CMR 9.01 (1) and (5)) (Board Policy No. 2011-01)

Non-Sterile Compounding (Simple Compounding Only)

Hazardous drugs shall be stored, prepared, and handled by appropriately trained personnel under conditions that protect

the healthcare workers and other personnel. (247 CMR 9.01 (3)) (USP Chapter <795>) NOTE: Compounding of

hazardous drugs is not considered simple compounding. A “yes” requires a full USP <795> Inspection.

All significant procedures performed in the compounding area are covered by written standard operating procedures

(SOPs). 247 CMR 6.07(1)(d) & (e)) (247 CMR 9.01 (3)) (USP Chapter <795>)

Compliance Inspection Report Page 7