Issue Date: December 9, 2014
Issued by: Center for Drug Evaluation and Research
Topic(s): Administrative / Procedural
Status: Draft

DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers

Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register. For questions regarding this draft document contact CDER Office of Compliance at 301-796-3130 or wdd3plrequirements@fda.hhs.gov .

Download the Guidance Document