New Guidance Documents
1. Guidance for Industry: The Drug Supply Chain Security Act Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How To Exchange Product Tracing Information
This draft guidance addresses the drug supply chain security provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), which requires the Secretary of the Department of Health and Human Services to establish initial standards for the interoperable exchange of transaction information, transaction history, and transaction statements, in paper or electronic format. Specifically, the guidance establishes standards for how transaction information, transaction history, and transaction statements should be exchanged among trading partners through the extension and/or use of current systems and processes.
2. Draft Guidance for Industry: Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reactions
This draft guidance is intended to inform manufacturers, members of the medical and scientific community, and other interested persons that at this time we do not intend to object to the marketing of single- and combination-ingredient, acetaminophen-containing, nonprescription (commonly referred to as over-the-counter (OTC)) drug products bearing a warning as described in the draft guidance alerting consumers that the use of acetaminophen may cause severe skin reactions.
Federal Register Notice
Guidance Document
3. Additional guidance for outsourcing facilities that compound sterile human drugs
FDA has issued three additional policy documents to assist entities that compound sterile human drugs with registering as outsourcing facilities. The policy documents will also assist entities with complying with provisions of the Drug Quality and Security Act (DQSA), which was enacted in November 2013.
The new guidance documents are:
- Final guidance on registration of human drug compounding outsourcing facilities under section 503B of the FD&C Act. This final guidance assists compounding facilities that decide to register as outsourcing facilities with the logistics of registering with the FDA, and the process for registering, re-registering, and de-registering.
- Final guidance on fees for human drug compounding outsourcing facilities under sections 503B and 744K of the FD&C Act. This final guidance provides information about the fees that a facility must pay to register as an outsourcing facility; how facilities can submit payment to the FDA; the consequences of failure to pay fees; and how a facility can qualify as a small business to obtain a reduction in registration fees. The guidance also provides information on fees that may be assessed for reinspection of outsourcing facilities.
- Revised draft guidance on electronic drug product reporting for human drug compounding outsourcing facilities under section 503B of the FD&C Act. This revised draft guidance provides information about the electronic submission of drug product reports to the FDA for registered outsourcing facilities. Upon initial registration as an outsourcing facility and twice each year, registrants must electronically submit a drug product report to the FDA. This report must identify all drugs compounded by the outsourcing facility during the previous six-month period and provide certain information for each compounded drug.
The draft guidance on electronic drug product reporting is available in the Federal Register for public comment for 60 days.
The Small Business and Industry Assistance program in the Center for Drug Evaluation and Research (CDER SBIA) provides guidance and information to regulated domestic and international small pharmaceutical business and industry through its website, email notifications, and workshops. This notification system provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical business, which includes Federal Register notices, guidances, workshop announcements, etc. This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, please contact us Monday through Friday 8:00AM - 4:30PM.
- Email: CDERSBIA@fda.hhs.gov
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