Automated Pharmacy Systems
Effective Dec 6, 2024Mass. Register #1536MGL c. 94C, §§ 6, 19B, 19C MGL c. 112, § 30 MGL c. 112, § 42ABoard of Registration in Pharmacy
(1) A pharmacy may dispense Schedule IV - VI controlled substances from an Automated Pharmacy System ("APS") to a patient or a patient's agent during or after pharmacy hours of operation provided the following requirements are met:
- (a) The APS is located within the same building as the pharmacy.
- (b) The APS is secured against or within a wall or floor in a manner that prevents unauthorized access and removal.
- (c) The location and APS are monitored by continuous, recordable video surveillance.
- (d) A pharmacy may not stock medications in an APS that require refrigeration or reconstitution.
- (e) The APS utilizes industry standard technological verification, such as barcode verification, electronic verification, weight verification, radio frequency identification, or another similar process, to ensure the correct medication is dispensed to the correct patient.
- (f) The APS or the pharmacy that operates the APS maintains electronic data that creates an audit trail of activity and includes the identity of each person to whom a drug was released.
- (g) The pharmacy provides the patient an opportunity for a pharmacist consultation during all hours that the APS is in operation for dispensing.
- (h) The pharmacy allows the patient to choose whether or not to use an APS.
(2) A pharmacy with an APS shall maintain policies and procedures pertaining to the APS that include:
- (a) APS location(s);
- (b) operation and maintenance;
- (c) security;
- (d) controlled substances accountability;
- (e) quality assurance;
- (f) stocking and return activities; and
- (g) patient confidentiality.