Recommendations for Redispensing (Repurposing) of Patient Medications
What is redispensing (repurposing)?
When a medication is received from a pharmacy and then is no longer in use by patient A, the name is removed and a new name was written on the blister pack/vial and dispensed to patient B.
Can redispensing (repurposing) be used for medications?
Redispensing (repurposing) is prohibited with certain exceptions pursuant to the Rules of the Board of Regents NYS Office of the Professions, Part 29:
29.7(a)(14) - Placing in stock of any pharmacy any part of any prescription compounded or dispensed which is returned by a patient; provided, however, that in a health care facility, including but not limited to a general hospital, which has its own pharmacy and in which unit-dose medication is dispensed to inpatients, each dose being individually sealed and labeled with the name of the drug, dosage strength, manufacturer's control number and expiration date, the unused unit dose of medication may be returned to the pharmacy of the facility for redispensing; and provided further that unused medication may be returned to pharmacies by residential health care facilities in accordance with the provisions of 10 NYCRR 415.18(f) or by other facilities, including but not limited to county correctional facilities, provided that such other facilities utilize standards, policies and procedures determined by the State Board of Pharmacy to be equivalent to those enumerated in 10 NYCRR 415.18(f).
29.7 (a)(15)(i) - Repacking of drugs in a pharmacy, except by a pharmacist or under his/her immediate and personal supervision. Labels on repacked drugs shall bear sufficient information for proper identification and safety. A repacking record shall be maintained, including the name, strength, lot number, quantity and name of the manufacturer and/or distributor of the drug repacked, the date of the repacking, the number of packages prepared, the number of dosage units in each package, the signature of the person performing the repacking operation, the signature of the pharmacist who supervised the repacking, and such other identifying marks added by the pharmacy for internal recordkeeping purposes. Drugs repacked for in-house use only shall have an expiration date 12 months, or 50 percent of the time remaining to the manufacturer's expiration date, whichever is less, from the date of repacking. For the repacking of drugs by manufacturers and wholesalers, the provisions of Parts 210 and 211 of Title 21, Code of Federal Regulations (1984 edition, Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402: 1984, available at New York State Board of Pharmacy, Office of the Professions, State Education Building - 2nd floor, 89 Washington Avenue, Albany, New York 12234), shall apply. Repacking records shall be maintained for five years and shall be made available to the department for review and copying.
It should also be noted that pursuant to FDA CPG Sec. 460.300 Return of Unused Prescription Drugs to Pharmacy Stock a pharmacist should not return drugs products to his stock once they have been out of his possession. It could be a dangerous practice for pharmacists to accept and return to stock the unused portions of prescriptions that are returned by patrons, because he would no longer have any assurance of the strength, quality, purity or identity of the articles.
Many state boards of pharmacy have issued regulations specifically forbidding the practice. We endorse the actions of these State boards as being in the interest of public health.
The pharmacist or doctor dispensing a drug is legally responsible for all hazards of contamination or adulteration that may arise, should he mix returned portions of drugs to his shelf stocks. Some of our investigations in the past have shown that drugs returned by patrons and subsequently resold by the pharmacist were responsible for injuries.