Repacking of Drugs in a Pharmacy

GENERAL REPACKING REQUIREMENTS

  • Must be done by or under direct supervision of a pharmacist
  • Labels must include identification and safety information
  • repacking record must be maintained

REPACKING RECORD MUST INCLUDE

  • Drug name and strength
  • Lot number
  • Quantity repacked
  • Manufacturer/distributor name
  • Date of repacking
  • Number of packages and dosage units per package
  • Signatures of repacker and supervising pharmacist
  • Internal tracking marks
  • Expiration: 12 months or 50% of manufacturer’s remaining shelf life, whichever is less
  • Records must be retained for 5 years

Rules of the Board of Regents §29.7 (a)(15)


REPACKED BLISTERS RETURNED FOR REDISPENSING

•           Partially used "blister packs" may be redispensed only as returned.
•        Partially used "blister packs" may not be emptied and repackaged.
•        Additional units of medication may not be added to partially used "blister packs."

Title 10 - NYCRR, Part 415 - Nursing Homes-Minimum Standards, Part 415.18 - Pharmacy services

CUSTOMIZED PATIENT MEDICATION PACKAGES (CO-MINGLED)

  • Dispensed in moisture-proof, tamper-evident containers
  • Label affixed to immediate container with required info
  • Must comply with Education Law 6810(1)
  • Only repackaged for the original patient
  • Requires patient, caregiver, or prescriber consent
  • Patient/caregiver must be instructed on use and identification
  • Controlled substances and unstable/incompatible drugs are prohibited
  • record of each package must be maintained

LABELING REQUIREMENTS FOR CO-MINGLED PACKAGES

  • Name, strength, physical description, and quantity of each drug
  • Dispenser’s address and phone number
  • Expiration date: max 60 days or shortest drug expiration
  • Unique serial numbers for each prescription and the package
  • Storage instructions and warnings

CUSTOMIZED PACKAGE RECORDS MUST INCLUDE

  • Patient’s name and address
  • Serial numbers of prescriptions
  • Manufacturer/labeler and lot numbers
  • Packaging description for duplication
  • Date of preparation and assigned expiration
  • Special labeling instructions
  • Name/initials of preparing pharmacist

References


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LAST UPDATED - APRIL 21, 2026

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Repacking of Drugs