247 C.M.R. 9.21 – Security of Controlled Substances

(1) A pharmacy shall store all controlled substances within the secured prescription area and in a safe and secure manner.
(2) A pharmacy shall store Schedules II through V controlled substances in a securely locked and substantially constructed cabinet, or similarly secured storage area, or dispersed throughout the stock of Schedule VI controlled substances and in such a manner as to obstruct theft and diversion.
(3) A pharmacy shall maintain a centrally monitored security system that is able to detect a breach in security and is designed to prevent theft. A pharmacy shall activate the security system when the pharmacy is closed.
(4) A pharmacy shall maintain surveillance cameras in a manner designed to record theft and diversion of controlled substances. A pharmacy shall retain video records for at least 14 days or, in the case of known or suspected theft or diversion, at least two years.
(5) A pharmacy that is located within another retail establishment shall be secured by a floor to ceiling barrier, securely locked and separately alarmed at all times when the pharmacy is closed.
(6) The pharmacist Manager of Record and the pharmacist on duty are responsible for pharmacy security and shall control access to the prescription area.
(7) All drug order deliveries containing controlled substances shall be delivered directly to the pharmacy.
(8) Schedule II Perpetual inventory
1. (a) A pharmacy and pharmacist shall maintain a perpetual inventory of each controlled substance in Schedule II which the pharmacy has received, dispensed, or disposed of. The perpetual inventory may be in a hard copy, written format or in an electronic format. The perpetual inventory shall reflect the amount of each Schedule II controlled substance that is located on the pharmacy premises.
2. (b) The perpetual inventory record shall include the names and strengths of each Schedule II control substance, quantity of each drug purchased or added to inventory, starting inventory, prescription numbers, dispensed quantity, remaining balance, and pharmacist identification for each transaction.
3. (c) A pharmacy shall reconcile the perpetual inventory for each Schedule II controlled substance at least once every ten days by performing an accurate physical count of inventory on hand and comparing that number with the perpetual inventory. The Manager of Record shall investigate any discrepancy and report any significant loss or suspected theft in accordance with federal and state requirements.
4. (d) A pharmacy shall require any inventory adjustment resulting from a discrepancy be performed only by the pharmacist Manager of Record. In the absence of the Manager of Record, a pharmacist designee may make the changes and report to Manager of Record.
5. (e) An unlicensed individual may not make any entry into or adjust the perpetual inventory.
6. (f) A certified pharmacy technician may make entries into the perpetual inventory.
(9) A pharmacy shall maintain an accurate record of all controlled substances returned to a reverse distributor or disposed of in accordance with state and federal laws and regulations, including proper DEA forms in the case of Schedule II controlled substances.
(10) Each requirement of 247 CMR 9.21 shall apply to controlled substances that are expired, quarantined, or pending reverse distribution.
(11) The requirements of 247 CMR 9.21 do not apply to non-resident pharmacies.
(12) An institutional sterile compounding pharmacy shall store and secure controlled substances in accordance with 105 CMR 700.000: Implementation of M.G.L. c. 94C.