The following questions and answers address the product tracing provisions of the Drug Supply Chain Security Act the agency receives most frequently.
No. Beginning January 1, 2015, the “pedigree” provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (added by the Prescription Drug Marketing Act 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received the drug “…a statement…identifying each prior sale, purchase, or trade of such drug…” no longer exists and is no longer in effect.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.
No. The requirements in sections 582(b)(1)(A), (c)(1)(A), (d)(1)(A), and (e)(1)(A) related to transaction information, transaction history and transaction statements apply to transactions. The term “transaction” is defined in section 581(24)(A) of the FD&C Act to be a “transfer of product between persons in which a change of ownership occurs” subject to exemptions specified in section 581(24)(B). Please refer to section 581(13) of the FD&C Act for the definition of “product,” which excludes certain prescription drugs.
No, FDA has not established standardized forms for such product tracing information. However, the Agency has issued a draft guidance, “DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing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 establishes initial standards to help trading partners understand the methods available for exchanging product tracing information.
Section 582(d)(1)(A)(ii) of the FD&C Act states that “a dispenser . . . prior to, or at the time of, each transaction in which the dispenser transfers ownership of a product (but not including dispensing to a patient or returns) shall provide the subsequent owner with transaction history, transaction information, and a transaction statement for the product, except that the requirements of this clause shall not apply to sales by a dispenser to another dispenser to fulfill a specific patient need.” Section 581(19) of the FD&C Act defines “specific patient need” as the transfer of a product from one pharmacy to another to fill a prescription for an identified patient. Section 581(19) further states that this term 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.
Section 582(a)(1) of the FD&C Act states that “Each manufacturer, repackager, wholesale distributor, and dispenser shall comply with the requirements set forth in [section 582] with respect to the role of such manufacturer, repackager, wholesale distributor, or dispenser in a transaction involving product. If an entity meets the definition of more than one of the entities listed in the preceding sentence, such entity shall comply with all applicable requirements in [section 582], but shall not be required to duplicate requirements.” For guidance on this provision, please refer to section III.A of “DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information.”
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. From there, you can navigate to a number of DSCSA-related materials FDA has developed, including our guidance documents, Implementation Plan, “Are You Ready for the Drug Supply Chain Security Act web page”, and other DSCSA tools and resources.