Although the Drug Supply Chain Security Act of 2013 (DSCSA) required publication by 2015 of guidance addressing grandfathering of certain product identifier requirements for packages or homogeneous cases of finished dosage form prescription drugs, “its better late than never,” as the saying goes. On Monday November 27th, FDA announced the availability of draft guidance titled, “Grandfathering Policy for Packages and Homogenous [SIC] Cases of Product Without a Product Identifier.” Comments on the proposed draft are due by January 26, 2018. As FDA states in its Federal Register Notice announcing the draft guidance, a critical part of the DSCSA (Section 582(a)(5)(A)) requires each package and homogeneous case of product in the supply chain to contain by a specific date a product identifier encoded with the product’s standard numerical identifier, lot number, and expiration date. FDA’s draft guidance specifies whether and under what circumstances packages and homogeneous cases of product not labeled with an identifier will be exempt (“grandfathered”) from Section 582’s identifier requirement.
FDA states that this draft guidance must be read in conjunction with FDA’s previously issued draft guidance titled, “Product Identifier Requirements Under the Drug Supply Chain Security Act” (see our previous post here) where FDA announced, among other things, that it will exercise enforcement discretion for manufacturers that do not add a product identifier to each package and homogeneous case of product intended to be introduced in a transaction into commerce before November 27, 2018 (i.e., delaying the serialization deadline by one year).
The “scope” of the latest draft guidance is as follows: A package or homogeneous case of product “is in the ‘pharmaceutical distribution supply chain’ if it was packaged by the product’s manufacturer before November 27, 2018.” (Emphasis added.) Thus, a package or homogeneous case of a product that is not labeled with a product identifier “is eligible for an exemption under Section 582(a)(5)(A)” as described in the guidance ”only if the product’s manufacturer packaged the product before November 27, 2018.” (Emphasis added.) There also must be documentation that the product was packaged by a manufacturer before November 27, 2018. As an example, FDA states that if a package or homogeneous case not labeled with a product identifier is accompanied by transaction information (TI) or a transaction history (TH) indicating a sale before November 27, 2018, then a trading partner may “reasonably conclude” the product was “packaged” by the manufacturer before that date. However, if TI or TH does not include a sale prior to November 27, 2018, absent other indications that the product may be suspect or illegitimate, then the transaction statement (TS) “is one indication that the product was in the pharmaceutical distribution supply chain before that date.” One could wonder here whether “packaged” but “unsold” products qualify for the grandfathering exemption, and whether this will cause confusion for industry.
Concerning trading partner requirements under the grandfathering exemption, the draft guidance notes as follows:
Manufacturers, distributors, and dispensers are exempt from two requirements in Section 582 where there is documentation showing that the unserialized product was in the pharmaceutical distribution supply chain before November 27, 2018:
- Where investigating an unserialized product to determine whether it is illegitimate, the manufacturer is exempt from the requirement to use the product identifier for verification. However it still must validate the TH and TI, and otherwise investigate pursuant to Section 582(b)(4)(A)(i)(H).
- In circumstances were the authorized trading partner in possession of the product requests verification from the manufacturer, the manufacturer is exempt from verification using the product identifier, but still must follow the other requirements in Section 582(b)(4)(C) (i.e., advise concerning whether the product is indeed suspect or illegitimate).
For Wholesale Distributors:
- Wholesale distributors are exempt from Section 582(c)(2), which requires they only engage transactions involving serialized product after November 27, 2019.
- Wholesale distributors shall not be required to verify product using the product identifier beginning November 27, 2019, but they must validate applicable TH, TI and TS in their possession to determine whether the product is illegitimate.
- Dispensers are exempt from Section 582(d)(2), which requires they only engage transactions involving serialized product after November 27, 2020.
- Wholesale distributors shall not be required to verify product using the product identifier beginning November 27, 2020, but they must validate applicable TH, TI and TS in their possession to determine whether the product is illegitimate.
The grandfathering exemption applies to repackagers, with certain limitations:
- Repackagers are partially exempt when they receive unserialized product after November 27, 2018, if they accept product without a product identifier after that date. However, if the repackager transfers ownership of a product without an identifier after November 27, 2018, it must add a product identifier to the package or homogeneous case.
- Like other trading partners mentioned above, repackagers will not be required to verify a product using the product identifier (if the product does not have one) after November 27, 2018, but it must take other steps outlined in the statute to otherwise investigate whether the product is illegitimate, including verifying TH and TI in its possession.
- If a repackager initially repackaged and sold unserialized product prior to November 27, 2018, it is exempted from the requirement that, upon request, it verify the product using the product identifier, but it must still follow other relevant statutory requirements.
Importantly, the draft guidance states that trading partners may engage in transactions involving grandfathered products until product expiry. FDA states that, although there is no “sunset” date for the grandfathering exemption, it expects few unserialized products to remain in the supply chain by November 27, 2023.
Lastly, concerning saleable returned packages and homogeneous cases of product (i.e., trading partners’ accepting returns of and redistribution of product), for returns without product identifiers after November 27, 2018, manufacturers, distributors and repackagers are exempt from the requirement to verify the product identifier. Manufacturers are exempted from the requirement to add an identifier before redistribution. Repackagers are exempted from the requirement so long as they initially repackaged and sold the product without an identifier before November 27, 2018.
FDA makes clear that unlike the guidance on Product Identifier Requirements, above, where FDA is exercising enforcement discretion, in this draft guidance, eligible product is “grandfathered” or exempted from certain statutory requirements.