Section 456.621 - Return of Unused Unit-Dose Drugs(A)Returnable Drugs.(1)Requirement. The nursing facility must return to the dispensing pharmacy unused drugs in unit-dose packaging that are listed in Appendix F of the Nursing Facility Manual and that were dispensed to a MassHealth member, when the use of the drug for that member is discontinued. Such returns allow the pharmacy to credit the Division for unused doses, which reduces pharmaceutical waste. The nursing facility must return such drugs that meet the requirements of 130 CMR 456.621(A)(2), unless they are excluded under 130 CMR 456.621(B). The nursing facility must return such drugs as soon as possible, but no later than 30 days after the date that the drug is discontinued for the member, and no less than 90 days before the earliest expiration date printed on the drug's label.(2)Returnable Drugs. Drug products that are returned must comply with all applicable state and federal requirements, including those related to the safety, labeling, handling, and storage of drugs.(B)Excluded Drugs. Of the drugs described in 130 CMR 456.621(A), the following unit-dose-packaged drugs may not be returned to the pharmacy for credit to the Division: (1) drugs that were dispensed to a member whose other insurance paid for part or all of the prescription;(2) unused quantities of a prescription that are less than the minimum quantity identified in Appendix F of the Nursing Facility Manual;(3) drugs prescribed to a member who has been discharged or transferred to another facility when a physician, physician's assistant, or nurse practitioner has authorized the release of the drug to the patient or an authorized custodian upon discharge; and(4) drugs with an expiration date of less than 90 days from the date of the discontinuation of the drug.(C)Dosage Changes. When the prescriber changes the dosage of any drug described in 130 CMR 456.621(A), and the previously prescribed dosage of the drug can be used to accommodate the new dosage, the nursing facility must: (1) use up existing supplies of the drug dispensed to the member instead of returning the drug to the pharmacy;(2) document the dosage change in the member's record; and(3) apply a change-of-directions sticker over the directions on the pharmacy prescription label.(D)Preparation of Manifest. The nursing facility must prepare a manifest of all drugs listed in Appendix F of the Nursing Facility Manual that are being returned to the pharmacy. This manifest must accompany the returned drugs to the pharmacy, account for drugs that have been destroyed because the integrity of the drug has been compromised, and must include: (1) the name of the member to whom the drugs were originally dispensed;(2) the date that the unused drugs were returned to the pharmacy;(3) the prescription number under which the unused drugs were originally dispensed;(4) the name and strength of the unused drugs;(5) the quantity of unit doses returned; and(6) if the drug was destroyed, the quantity, reason, and date of destruction; along with the initials of the person preparing the manifest.(E)Recordkeeping Requirements. The nursing facility must establish tracking and recordkeeping systems for all unit-dose-packaged drugs returned pursuant to 130 CMR 456.621. The records must reflect sound standard business accounting practices; be available for review by the Division upon request; and be kept for at least seven years from the date of the return. The records must include: (1) a copy of the manifest described in 130 CMR 456.621(D) of each shipment of unused unit-dose-packaged drugs that has been returned to the pharmacy;(2) for unit-dose-packaged drugs that are not returned pursuant to 130 CMR 456.621(B), the reason that the drugs are not being returned; and(3) for unit-dose-packaged drugs that were destroyed, the quantity, reason, and date of destruction, along with the initials of the person who destroyed the drugs.