Last week the FDA posted final versions of two DSCSA guidance documents, and, a new draft Product Identifier Q&A document. The two final guidance documents include the grandfathering policy and the product identifier compliance policy that delayed enforcement of the product identifier and verification requirements until November 27, 2018. These documents are companions to each other, which is to say that they are pretty tightly related, and that’s why FDA would finalize them together.
There were no real substantive changes to either of these finalized documents but the FDA has made some cosmetic and structural changes. The only significant change was to remove from the final compliance policy guidance document the detailed description of the delayed enforcement. This resulted in the removal of 4 ½ pages of text. It seems abrupt, but, on closer analysis, the removed text was very similar to text found in the draft grandfathering guidance. That text remains in the final grandfathering guidance, so, rather than keep the similar details in the compliance policy guidance, FDA simply refers to the final grandfathering guidance. The resulting effect appears to be the same as before, but with overall fewer words.
Draft guidance is marked “Draft – Not for Implementation”. That phrase is removed from the final guidance documents. But, the phrase “Contains Nonbinding Recommendations” is included in both.
You can download a copy of the final guidance documents here:
- Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier Guidance for Industry
- Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy Guidance for Industry
For my original analysis of the draft versions of these guidance documents, see “FDA’s New DSCSA Grandfathering Guidance”, “FDA Delays Enforcement of DSCSA November Deadline: What It Means”, “DSCSA and RxTrace: The Song Remains The Same” and “DSCSA Cascading Delays”.
NEW DRAFT PRODUCT IDENTIFIER Q&A DOCUMENT
The more interesting document posted last week is the draft Product Identifier Q&A document. Generally, this document,
“…is intended to help manufacturers and repackagers understand the requirements to affix or imprint a product identifier on each package and homogenous case of product that they introduce in a transaction into commerce to satisfy the product identifier requirement of section 582 of the FD&C Act. The recommendations in this guidance are intended to assist manufacturers and repackagers in standardizing both the human-readable and machine-readable format of the information that is contained in the product identifier.”
It includes Q&A broken into the following categories:
- Agency Contacts
- Product Identifiers
- Submission of Label Changes Under the DSCSA
- The Product Identifier Requirement of the DSCSA and the Linear Barcode Requirement Under 21 CFR 201.25
- Examples of When the Product Identifier is Required Under the DSCSA and the Linear Barcode is Required Under § 201.25
I am returning to the US from a business trip to India as I write this so I will withhold my analysis of the answers provided by the FDA until next week. You can download a copy of the draft Q&A document here:
- Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers Guidance for Industry
More next week.