Pennsylvania Code
Title 28 - HEALTH AND SAFETY
Part III - Prevention of Diseases
Chapter 25 - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS
Subchapter A - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS
GOOD MANUFACTURING PRACTICE IN MANUFACTURE, PROCESSING, PACKING OR HOLDING OF DRUGS
Section 25.20 - Distribution records
Current through Register Vol. 54, No. 44, November 2, 2024
(a) Finished goods warehouse control and distribution procedures shall include a system by which the distribution of each lot of drug can be readily determined to facilitate its recall if necessary. Records within the system shall contain the name and address of the consignee, date and quantity shipped, and lot or control number of the drug. Records shall be retained for at least 2 years after the distribution of the drug has been completed or 1 year after the expiration date of the drug, whichever is longer.
(b) To assure the quality of the product, finished goods warehouse control shall also include a system whereby the oldest approved stock is distributed first whenever possible.
