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  6. Drug Supply Chain Security Act Product Tracing Requirements | Frequently Asked Questions
  1. Drug Supply Chain Security Act (DSCSA)

Drug Supply Chain Security Act Product Tracing Requirements | Frequently Asked Questions

The following are common questions and answers about the product tracing requirements under the the Drug Supply Chain Security Act.

Is the pedigree provision of the Prescription Drug Marketing Act (PDMA) still in effect?

No. As of January 1, 2015, the “pedigree” provision of the Federal Food, Drug and Cosmetic (FD&C) Act (added by the PDMA of 1987) that required certain wholesale distributors to provide to the person who received the drug “…a statement…identifying each prior sale, purchase or trade of such drug…” no longer exists and is no longer in effect. 

DSCSA removed the drug pedigree language and replaced it with new language in section 503(e) of the FD&C Act, which pertains to new licensing requirements and uniform national standards for wholesale distribution of prescription drugs. 

DSCSA also added product tracing requirements in section 582 of the FD&C Act to provide and capture product tracing information associated with each transaction for most human prescription drugs in finished form.

Which drugs do and do not fall under the DSCSA requirements for product tracing, product identifier, authorized trading partner and verification?

Section 582 of the FD&C Act defines a product as “a prescription drug in finished dosage form for administration to a patient without substantial further manufacturing (such as capsules, tablets and lyophilized products before reconstitution).”

DSCSA requirements do not apply to:

  • Over-the-counter drugs
  • Animal drugs
  • Blood or blood components intended for transfusion
  • Radioactive drugs or biologic products
  • Imaging drugs
  • Certain intravenous (IV) drugs
  • Medical gases
  • Certain homeopathic drugs
  • Lawfully compounded drugs

There are several exclusions in the definition of transaction noted in section 581(24) of the FD&C Act, which result in DSCSA requirements not applying to certain transfers of a drug.

Who needs to comply with DSCSA requirements for product tracing, product identifier, authorized trading partner and verification?

Product tracing, product identifier, authorized trading partner and verification requirements in section 582 of the FD&C Act apply to trading partners as defined in section 581(23)(A) of the FD&C Act which includes drug manufacturers, repackagers, wholesale distributors and dispensers (primarily pharmacies) need to comply with these requirements need to comply with these requirements. 

Visit our Identifying Trading Partners under the Drug Supply Chain Security Act guidance for more information.

An entity that meets more than one trading partner definition must comply with all applicable requirements in section 582 of the FD&C Act, but not duplicative requirements. Visit section 582(a)(1) of the FD&C Act for more information.

Does FDA have standardized forms for transaction information, transaction history and transaction statements that I can use?

No. FDA has not established standardized forms for such product tracing information. The agency issued a final guidance, “DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information,” that identifies standards to help trading partners understand the methods available for exchanging product tracing information.

When a pharmacy sells a product to another pharmacy, do the DSCSA product tracing requirements related to transaction history, transaction information and transaction statements apply?

Yes, except for sales by a dispenser to another dispenser to fulfill a specific patient need. The law defines a “specific patient need” as the transfer of a product from one pharmacy to another to fill a prescription for an identified patient and does not include the transfer of a product from one pharmacy to another for the purpose of increasing or replenishing stock in anticipation of a potential need. Visit sections 581(19) and 582(d)(1)(A)(ii) of the FD&C Act for more information.

Do veterinarians or veterinary clinics have any obligations under product tracing or other obligations under DSCSA when they use human prescription drugs in animals?

No. If a veterinarian or a veterinary clinic uses human prescription drugs only in animals in accordance with section 512(a)(5) of the FD&C Act, the veterinarian or veterinary clinic is excluded from the definition of dispenser under section 581(3)(B) of the FD&C Act.

I am being asked to obtain a Global Location Number (GLN) by my suppliers (e.g., wholesale distributor or manufacturer). Is this a requirement under DSCSA?

No. DSCSA does not require trading partners to obtain a specific location identifier, such as a GLN. However, for the enhanced drug distribution security requirements in section 582(g)(1) of the FD&C Act, FDA recommends using the GS1 Electronic Product Code Information Services (EPCIS) standard to enable secure, interoperable, electronic data exchange among the pharmaceutical distribution chain. Your trading partner may ask you to obtain a GLN, which is a data element of EPCIS, as a business requirement to facilitate data exchange using EPCIS. 

Visit section VIII of our final guidance, “DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information.”

 
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