Policy on Return for Redispensing of Medications from Long Term Care Facilities
Interpretation of M.G.L. c. 94C, � 18(d)
re: Issuance of Prescription by Practitioner or Physician
According to Board of Registration in Pharmacy (Board) regulations (247 CMR); specifically,
9.01: Code of Professional Conduct for Registered Pharmacists, Pharmacies and Pharmacy Departments
(1) A registered pharmacist shall at all times conduct professional activities in conformity with federal, state and municipal laws, ordinances and/or regulations, including the regulations of the Board.
(2) A pharmacist shall not dispense drugs, devices, or other substances in a manner which is intended, either directly or indirectly, to circumvent the law.
(3) A pharmacist shall observe the standards of the current United States Pharmacopeia (USP).
(4) Unless otherwise permitted by law, a pharmacist shall not redispense any medication which has been previously dispensed.
In accordance with the authority granted by M.G.L. c. 111, s. 25I, the Department of Public Health (DPH) has adopted a Policy on Return for Redispensing of Medications from Long Term Care Facilities permitting long term care facilities (LTCFs) licensed by DPH to return certain unused unit-dose packaged and certain other unused Schedule VI and over-the-counter medications to pharmacies for the purpose of redispensing to patients. This DPH policy permits LTCFs to utilize unit-dose packaging for the management and administration of pharmaceuticals to patients.
In accordance with 247 CMR 9.01(4), the Board has voted to adopt the DPH's Policy on Return for Redispensing of Medications from Long Term Care Facilities (attached PDF) and permit the redispensing of certain medications from LTCFs in accordance with DPH policy requirements; provided that the pharmacist redispensing any previously dispensed prescription or non-prescription drug product has determined, using proper professional judgment, that the drug meets USP standards compendia for dispensing. Additionally, to redispense permitted medications, the pharmacy will be required to have a written policy regarding the return for redispensing of Schedule VI and over-the-counter medications returned from LTCFs. The written policy must address patient safety issues including, but not limited to:
- Ensuring that the drugs returned were originally dispensed by the same pharmacy;
- Ensuring that a pharmacist is in control of the redispensing process and has verified each order before redispensing;
- Ensuring dispensers, repackagers and ultimate users can be identified and notified in the event of a recall;
- Minimizing opportunities for tampering and diversion;
- Verifying the drugs are not expired and have a minimum of three (3) months/ninety (90) days remaining to the beyond use date or expiration date, whichever is earlier;
- Requiring that the pharmacist obtain assurances from a responsible person in charge of the drugs that the drugs have been stored in accordance with the manufacturer's recommendations and current United States Pharmacopeia standards compendia;
- Disallowing the return or redispensing of any temperature sensitive drug or any drug requiring refrigeration;
- Disallowing the return or redispensing of any compounded or reconstituted medication;
- Disallowing the return or redispensing of any medication which appears to be adulterated or misbranded;
- Disallowing the return or reuse of any drug designated as Schedule II-V controlled substances, in accordance with M.G.L. c. 94C, s. 3;
- Disallowing the return or reuse of drugs which may have had their integrity, packaging or labeling compromised (e.g., through environmental damage such as water damage, crushing, a broken seal, a torn or marked label);
- Requiring the maintenance of a repackaging record, including the name, strength, lot number, quantity, manufacturer and/or distributor information, date of repackaging, number of packages prepared, number of dosage units in each package, signature of person performing the repackaging, signature of the supervising pharmacist, and such other identifying marks as may be added by the pharmacy for recordkeeping purposes;
- Requiring the maintenance of a packing manifest for each prescription drug returned by the facility to the pharmacy, to be readily retrievable and maintained at the dispensing pharmacy for a minimum of seven years; and,
- Requiring that a pharmacist has determined, using proper professional judgment, that all such drugs are appropriate for redispensing.
Board Adoption Date: March 26, 2002
Attachment: DPH Policy on Return for Redispensing of Medications from Long Term Care Facilities (5 pages)
This information is provided by the Division of Health Professions Licensure within the Department of Public Health.