The following are common questions and answers about supply chain security requirements of the Drug Supply Chain Security Act.
No. Beginning January 1, 2015, the “pedigree” provision of the Federal Food, Drug, and Cosmetic Act (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received the drug “…a statement…identifying each prior sale, purchase, or trade of such drug…” no longer exists and is no longer in effect. Section 204 of the 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. The DSCSA also added product tracing requirements in section 582 of the FD&C Act to provide and capture the transaction information, transaction history, and transaction statement (referred to as “product tracing information”) associated with each transaction for most human prescription drugs in finished form.
If your drug is not explicitly excepted or excluded by the law, DSCSA requirements will generally apply. DSCSA requirements do not apply to nonprescription drugs (over-the-counter drugs) or animal drugs (drugs subject to section 512 of the FD&C Act).
Product tracing, product identifier, authorized trading partner, and verification requirements in section 582 of the FD&C Act apply to product as defined in section 581(13) of the FD&C Act. Product means “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).”
The section 582 requirements do not apply to:
- Blood or blood components intended for transfusion
- Radioactive drugs or biologic products
- Imaging drugs
- Certain intravenous (IV) products
- Medical gases
- Certain homeopathic drugs
- Lawfully compounded drugs
There are also 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 drug.
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) which includes drug manufacturers, repackagers, wholesale distributors and dispensers (primarily pharmacies) need to comply with these requirements need to comply with these requirements. For more information, see the guidance for industry, “Identifying Trading Partners under the Drug Supply Chain Security Act.”
If an entity meets more than one trading partner definition, it must comply with all applicable requirements in section 582 of the FD&C Act, but is not required to duplicate requirements. See section 582(a)(1) of the FD&C Act.
No, FDA has not established standardized forms for such product tracing information. However, the Agency issued a draft 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.
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. You can find more information in sections 581(19) and 582(d)(1)(A)(ii) of the FD&C Act.
FDA generally does not provide advice to individual entities regarding their obligations under the DSCSA. We encourage those interested in learning more about the DSCSA to visit FDA’s main DSCSA web page for the most current information and educational webinars. From there, you can navigate to DSCSA guidance documents, submit drug notification to FDA for illegitimate products, find information about our public meetings, and other DSCSA tools and resources.