Jan 11 -- The Food and Drug Administration (FDA, Agency, or we) announces it has asked OMB to approve an information collection implementing the Drug Supply Chain Security Act and invites the public to comment by February 25, 2022.
Under the proposal, manufacturers, repackagers, wholesale distributors, and dispensers must: (1) Notify FDA when they have determined that a product in their possession or control is illegitimate or if a manufacturer when they determine that a product has a high risk of illegitimacy; (2) terminate such notifications after consultation with FDA; (3) notify certain immediate trading partners about an illegitimate product or if a manufacturer about a product with a high risk of illegitimacy; and (4) notify immediate trading partners when such notifications are terminated.
To strengthen FDA's ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful, section 203 of the DSCSA added enhanced security provisions to section 582 of the FD&C Act. The terms and definitions established in section 581 of the FD&C Act are applicable to provisions set forth in section 582, which require the capture, exchange, and verification of pharmaceutical drug product transaction information, transaction history, and transaction statements by respondents. Section 582 of the FD&C Act also requires that certain notifications are made by respondents to FDA and provides for respondent notification disclosures applicable to suspect and illegitimate product data elements. The recordkeeping and notification provisions included in section 582 also provide for inspection of records by FDA and establish minimum retention schedules. Finally, section 582 of the FD&C Act provides for the establishment of waivers, exceptions, and exemptions from any of the requirements.
To assist respondents with reporting requirements, we developed Form FDA 3911 entitled Drug Notification and the corresponding instructional document “INSTRUCTIONS FOR COMPLETION OF FORM FDA 3911—DRUG NOTIFICATION.” (
https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/drug-notifications-frequently-asked-questions). Form FDA 3911 is intended to provide a uniform format for initial notifications, followup notifications, and requests for the termination of a notification.
The guidance document entitled “Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification” (Revision 1, June 2021; available at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/drug-supply-chain-security-act-implementation-identification-suspect-product-and-notification) was developed to assist respondents with identifying a suspect product as defined at section 581(21) of the FD&C Act and in making determinations in this regard.
We also developed the draft guidance document entitled “Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act” (May 2018; available at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/waivers-exceptions-and-exemptions-requirements-section-582-federal-food-drug-and-cosmetic-act ). Respondents seeking waivers, exceptions, or exemptions from any of the requirements may submit a request to FDA. The draft guidance explains Agency established processes by which: (1) A trading partner may request a waiver from certain requirements in section 582 of the FD&C Act if it would result in an undue economic hardship or for emergency medical reasons; (2) a manufacturer or repackager may request an exception to the section 582 requirements related to product identifiers if a product is packaged in a container too small or otherwise unable to accommodate a label with sufficient space to bear the required information; and (3) FDA may determine other products or transactions that shall be exempt from requirements of section 582.
We use the information to evaluate the likelihood that illegitimate products or products with a high risk of illegitimacy may be widely disseminated in the U.S. supply chain so that mitigation of public health risks can be expeditiously administered. Notifying FDA and trading partners that could possess the illegitimate product (or product with a high risk of illegitimacy) allows stakeholders to work collaboratively to remove potentially dangerous product from the supply chain and alert consumers about the product, if necessary.
FDA Drug Supply Chain Security Act webpage:
https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa
FDA submission to OMB:
https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202107-0910-010 Click on IC List for collection instruments, View Supporting Statement for technical documentation. Submit comments through this site.
FR notice inviting comment:
https://www.federalregister.gov/documents/2022/01/11/2022-00327/agency-information-collection-activities-submission-for-office-of-management-and-budget-review (Note: Although this notice says the due date is Feb 10, OMB accepts comments up to 30 days after the FDA submits its request to OMB, which occurred on Jan 26. Thirty days out is February 25.)
For AEA members wishing to submit comments, "A Primer on How to Respond to Calls for Comment on Federal Data Collections" is available at
https://www.aeaweb.org/content/file?id=5806