A pharmacy repackaging for stock any non-sterile drugs shall do all of the following:

1. (1) The repackaging for stock process is conducted under conditions that ensure the integrity of the drug.
2. (2) Products repackaged for stock shall include a beyond use date that ensures the integrity of the drug.
3. (3) The repackaged container shall be selected to mitigate adulteration from light, temperature and humidity.

4. (4) The repackaged for stock drugs are labeled physically or electronically with all the following components:

   1. (a) Drug name, strength, form and beyond use date.

   2. (b) One of the following identifiers:

      1. 1. Pharmacy control number.
      2. 2. NDC number and manufacturer lot number.
      3. 3. Name of manufacturer or distributer of the drug product, and the manufacturer lot number.

5. (5) Records of all repackaging for stock operations are maintained and include all the following:

   1. (a) Name, strength, form, quantity per container, and quantity of containers.
   2. (b) NDC number or the name of the manufacturer or distributor of the drug product.
   3. (c) Manufacturer lot number.
   4. (d) Original container’s expiration date and the beyond-use date for the new containers.
   5. (e) First and last name of the pharmacist or delegate that repackaged the drug and the first and last name of the pharmacist that verified the accuracy of the repackaging.
   6. (f) Date of repackaging.
   7. (g) Any pharmacy control numbers.

History

History: CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21.