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Wholesale Distributor and Dispenser Verification | FDA Guidance for Industry

Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product— Compliance Policies

This guidance is for immediate implementation!!

FDA is issuing this guidance for immediate implementation in accordance with 21 CFR 10.115(g)(2).

The Drug Supply Chain Security Act (DSCSA) (Title II of Public Law 113-54) was signed into law on November 27, 2013.

Section 202 of the DSCSA added section 582 to the FD&C Act.

This section established product tracing, product identifier, authorized trading partner, and verification requirements for manufacturers, whole sale distributors, repackagers, and dispensers to facilitate the tracing of a product through the pharmaceutical distribution supply chain.

Failure to comply with the requirements of section 582 of the FD&C Act is prohibited under section 301(t) of the FD&C Act (21 U.S.C. 331(t)) and subject to enforcement action under the FD&C Act.

One requirement of the verification scheme outlined in the DSCSA is the verification of saleable returned product.

Under section 582(c)(4)(D) of the FD&C Act, wholesale distributors must have systems in place that will enable them to verify the product identifier, including the standardized numerical identifier, for each sealed homogeneous case of saleable returned product, or, if such product is not in a sealed homogeneous case, on each package of saleable returned product.

A saleable returned product may not be further distributed until the product identifier is verified.

The product should be handled as suspect product if the product identifier is not successfully verified (i.e., it should be quarantined and investigated).

In addition, section 582 of the FD&C Act requires certain trading partners (manufacturers, repackagers, wholesale distributors, and dispensers) to exchange transaction information, transaction history, and a transaction statement when engaging in transactions involving certain prescription drugs.

A transaction statement must include a statement that the entity transferring ownership in a transaction had systems and processes in place to comply with verification requirements under section 582 of the FD&C Act.

The 2020 Compliance Policies extended the previous enforcement policy for an additional 3 years, until November 27, 2023.

Section 582 also includes requirements for dispensers to verify product identifiers when investigating suspect or illegitimate product. Specifically, section 582(d)(4)(A)(ii)(II) of the FD&C Act provides that, effective November 27, 2020, dispensers must verify - 
“the product identifier, including the standardized numerical identifier, of at least 3 packages or 10 percent of such suspect product, whichever is greater, or all packages, if there are fewer than 3, corresponds with the product identifier for such product [in the dispenser’s possession or control”.

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Resource Person: BARBARA PIROLA
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