247 CMR 9.11
Pharmacy Processing Automation
(1) A pharmacy may utilize Pharmacy Processing Automation ("PPA") to count, fill vials or
compliance packaging, and label, provided the following requirements are met:
(a) the PPA utilizes technological verifications, such as bar code verification, electronic
verification, weight verification, radio frequency identification (RFID), or another similar
process, to ensure that the correct medication is dispensed; and
(b) if lot numbers are comingled in a single cell, the pharmacy maintains a policy and
procedure to quarantine all comingled lot numbers in the event a single lot number is
recalled.
(2) The pharmacy shall implement and maintain policies and procedures pertaining to the PPA
that include:
(a) operation and maintenance;
(b) security;
(c) controlled substance accountability;
(d) quality assurance; and
(e) stocking and return activities.