What are the Federal Drug Pedigree or Recordkeeping Requirements?
The FDA has published a guidance document regarding Drug pedigree requirements under the FDA as well an enforcement guideline. Links to these documents are listed under our related registration sites. Back To Top What are Pennsylvania’s pedigree requirements? PEDIGREE REQUIRMENTS Pennsylvania require that a drug distributor shall establish and maintain inventories and records of all transactions regarding the receipt and distribution or other disposition of prescription drugs. These records shall include the following information: (i) The source of the drugs, including the name and principal address of the seller or transferor, and the address of the location from which the drugs were shipped. (ii) The identity and quantity of the drugs received and distributed or disposed. (iii) The dates of receipt and distribution or other disposition of the drugs. Additionally Pennsylvania law requires compliance with all applicable federal laws including the current Pedigree requirements under the
