Compliance Inspection Report (Page 3 of 11) in pdf

Item

Requirements

YES

N/A

Comment / Observation

No.

Security

There shall be a separate working alarm for the pharmacy or pharmacy department which shall be activated when the

pharmacy or pharmacy department is closed. (247 CMR 6.02 (6) (d))

The pharmacy department must be secured by a floor to ceiling barrier, securely locked and separately alarmed at all

times when the pharmacy department is closed. (247 CMR 6.02 (6) (e))

The pharmacist Manager of Record and the pharmacist on duty shall be responsible for pharmacy security and shall

control access to the prescription area. (247 CMR 6.02 (6) (f))

All controlled substances in Schedules II through VI shall be stored within the prescription area. (247 CMR 6.02 (6) (a))

(247 CMR 6.02 (6) (b))

Controlled substances in Schedules II, III, IV, and V shall be stored in a securely locked and substantially constructed

cabinet, or dispersed in the prescription drug storage area throughout the stock of Schedule VI controlled substances in

such a manner as to obstruct the theft or diversion of these controlled substances. (247 CMR 6.02 (6) (c))

The pharmacy shall have written policies and procedures regarding the operation of the pharmacy during the temporary

absence of the pharmacist for breaks and meal periods. (247 CMR 9.01 (1)) (Board Policy No. 2000-03)

A pharmacist shall maintain patient confidentiality at all times. Confidential information shall include information

maintained by the pharmacist in the patient’s records or information which is communicated to the patient as part of

patient counseling. (247 CMR (9.01 (19))

Display

The following shall be conspicuously displayed within the pharmacy or pharmacy department:

(a) the pharmacy permit;

(b) the pharmacy’s Massachusetts controlled substance registration;

(d) whenever applicable, the pharmacy’s certificate of fitness. (247 CMR 6.02 (3) (a) (b) (c) (d))

A pharmacy or a pharmacy department shall conspicuously display, in legible letters not less than one inch high, over, on

or adjacent to the main entrance of the pharmacy or pharmacy department, the name of the pharmacist Manager of

Record who is responsible for the management and operation of the pharmacy or pharmacy department.

(247 CMR 6.02 (7))

A pharmacy or pharmacy department shall have a reasonably-sized sign affixed to the main entrance of the business or

otherwise installed in an easily observable area outside the premises, identifying the presence of a pharmacy or

pharmacy department. (247 CMR 6.02 (5))

The hours of operation shall be prominently posted at all consumer entrances to the pharmacy and, in the case of a

pharmacy department, the hours shall also be posted at all consumer entrances to the retail store and at the pharmacy

department. (247 CMR 6.02 (8) (a))

A sign of not less than 11 inches in height by 14 inches in width shall be posted in a conspicuous place, adjacent to the

area where prescriptions are dispensed, informing customers of their rights, pursuant to 247 CMR 9.07 and to M.G.L. c.

94C, § 21A, to counseling by a pharmacist where their prescription was filled. Said sign shall read, in letters not less than

½” in height: “Dear patients, you have the right to know about the proper use of your medication and its effects. If you

need more information please ask the pharmacist.” (247 CMR 9.07 (3) (c))

A pharmacy must provide a designated consultation area with signage stating “Patient Consultation Area”.

(247 CMR 6.01 (5) (d) (1))

Compliance Inspection Report Page 3

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