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Regulations of Connecticut State Agencies (Last Updated: June 14,2023) |
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Title17b Social Services |
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SubTitle17b-363a. Return of Drug Products to Pharmacies |
| Sec. 17b-363a-1. Return of drug products to pharmacies |
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Latest version.
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(a) Any vendor pharmacy that accepts for return drug products dispensed to long-term care facilities, pursuant to section 17b-363a of the Connecticut General Statutes, shall comply with the requirements of this section. (b) A vendor pharmacy shall not accept for return any drug products that do not meet the criteria for return under section 17b-363a of the Connecticut General Statutes. (c) A vendor pharmacy shall immediately physically inspect all drug products that are returned by long-term care facilities. Any drug products in original manufacturer's dispensing packages that have been opened, have had doses removed, or show any signs of tampering shall not be returned to stock. Any drug products packaged in unit dose or blister type packaging that appear to have been removed from and returned to the dispensing package, or drug products in such packaging that appears to have been tampered with or the integrity of which appears to be compromised in any way, shall not be returned to stock, except as permitted in subsection (d)(2) of this section. (d) Except as provided in subsections (b) and (c) of this section, a vendor pharmacy may return to stock for re-dispensing drug products: (1) packaged in original manufacturer's dispensing packages; (2) packaged in unit dose or blister type packaging whose individual labeling and integrity remains intact even though doses may have been removed from the outer package; or (3) originally packaged by the vendor pharmacy into multiple dose blister packaging. Except as otherwise permitted by this subdivision, such drug products shall be removed from the original dispensing package before being placed into pharmacy stock for re-dispensing. This process shall be done in a manner that insures that the lot number and expiration date for the drug product are maintained and that the individual doses of the drug product are not exposed to possible adulteration or cross-contamination. Generically equivalent drug products from more than one drug manufacturer shall not be co-mingled. Removal of the drug product from the original dispensing package prior to re-dispensing shall not be required for packaging from which no doses have been removed and for packaging that allows disassembly without handling the drug product, while maintaining product identification, lot number, and expiration date. (e) (1) All drug products re-dispensed on prescription from the vendor pharmacy shall be labeled with all required information, including lot number and expiration date. (2) The expiration date assigned to the drug product for re-dispensing shall be no later than the expiration date assigned to the product when originally dispensed, or no later than the earliest expiration date originally assigned to any dose contained in the repackaged multiple dose blister card dispensed. (3) The lot number assigned shall be the manufacturer's original lot number for products dispensed in manufacturers' original packaging, or a lot number assigned by the vendor pharmacy for a repackaged product, from which the original lot numbers of the doses contained may be referenced. |
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(Adopted effective June 6, 2001) |