Section 140.347 - Pharmacy Services by Clinics without Clinic PharmaciesIf the clinic does not maintain a clinic pharmacy, but drugs are stored and administered at the clinic directly to patients, the clinic shall comply with the requirements of 105 CMR 140.347 and 105 CMR 700.000: Implementation of M.G.L. c. 94C.
(A)Compliance with Federal and State Law. The clinic must register annually under the Controlled Substances Act with the Department pursuant to M.G.L. c. 94C, § 7 and shall comply with all applicable federal, state, and local drug laws and regulations.(B)Record System. The clinic professional services director or his or her designee shall be responsible for ensuring a record system that maintains control over the requisitioning and administration of controlled substances. The recordkeeping system shall comply with all federal and state laws and regulations.(C)Storage of Drugs. Drugs shall be stored under proper conditions to ensure product stability and security. Drug storage facilities shall be locked. Schedule II drugs shall be kept double locked.(D)Medications for External Use. The clinic shall accurately label each medication for external use as such, and shall store such medications separately from medications for internal use.(E)Outdated Drugs. Outdated drugs shall be eliminated from the clinic's stock in accordance with clinic policies. All drugs shall be destroyed in accordance with applicable state and federal laws.(F)Administration of Medications. All drugs administered directly to patients in the clinic shall be administered by appropriately licensed personnel. Prescriptions shall be issued for all drugs not administered within the clinic. However, drugs may be dispensed by a prescribing practitioner for immediate treatment until such time as a prescription can be filled at a pharmacy.(G)Labeling. All drugs shall be adequately and distinctly labeled.(H)Reference Source. The clinic shall maintain and make available up-to-date pharmaceutical reference materials for reference by clinic staff.Amended by Mass Register Issue 1443, eff. 5/14/2021.