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This chapter is intended to provide guidance to those engaged in repackaging of drug products in accordance with 21 CFR 10.90.

A pharmacist who repackages under the state law needs to apply (1) the principal information provided in the USP general information chapter This chapter provides information to any person who removes drugs from their original manufacturer's container and repacks them into a different container–closure system for resale or for distribution to hospitals or other pharmacies.

Palmer – On December 29, 2016, FDA issued final guidance reflecting its policy on Repackaging of Certain Human (Prescription) Drug Products by Pharmacies and Outsourcing Facilities, first issued in draft form in February of 2015, and blogged here.

This record shall include at least the following: (1) Name of drug, strength, dosage form, and quantity; (2) Manufacturer's or distributor's control number; (3) Manufacturer's or distributor's name, if a generic drug is used; (4) Pharmacy control number; (5) Manufacturer's or distributor's expiration date; (6) The pharmacy's expiration date or beyond-use date; (7) Positive identification of the pharmacist responsible for the repackaging of the drug.

These functions are beyond the regular practice of a pharmacist.

A repackager is required to register with the FDA and comply with current Good Manufacturing Practices (c GMPs) regulations in 21 CFR 210 and 211.

The container has to be obtained from the system's manufacturer and each new container can cost over 0.

In this particular situation, the 1/4 method would not be compliant.




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