Latest Posts › Prescription Drugs

Share:

FDA Approves Florida’s Section 804 Importation Program for Importation of Canadian Pharmaceuticals

On January 5, 2024 the Food and Drug Administration (FDA) issued its approval of the State of Florida’s proposal to import certain prescription drugs from Canada under the Section 804 Importation Program (SIP). This approval...more

FDA Releases Draft Interim Guidance on Bulk Drug Substances in Compounding Under Sections 503A and 503B of FDCA

The Food and Drug Administration (“FDA”) has released draft interim guidance documents that impact the use of bulk drug substances in compounding under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act...more

More Guidance Released from FDA for Drug Supply Chain Security Act Compliance

The Food and Drug Administration (“FDA”) released additional guidance documents on Wednesday, August 30th pertaining to the enhanced drug distribution security requirements under the Drug Supply Chain Security Act (“DSCSA”). ...more

FDA Announces Guidance for DSCSA Process to Request a Waiver, Exception, or Exemption

On Friday, August 4th, the Food and Drug Administration (“FDA”) announced the availability of a final guidance document, titled “Waivers, Exceptions, and Exemptions From the Requirements of Section 582 of the Federal Food,...more

FDA Announces Draft Guidance on Outsourcing Facility Sales

The U.S. Food and Drug Administration (FDA) issued a draft guidance document, June 27, that describes FDA’s current thinking on the prohibition of wholesaling human drugs by a 503B outsourcing facility under the Food, Drugs,...more

Final Definitions and Considerations for Trading Partners to Prepare for DSCSA Implementation

On March 16, 2023, the Food and Drug Administration (FDA) released final guidance regarding definitions of "suspect product" and "illegitimate product" as part of a continued effort to prepare trading partners for the...more

FDA Publishes New Guidance on Compounding Animal Drugs from Bulk Drug Substances

The wait is finally over. On April 14, 2022, the Food and Drug Administration (FDA) published its guidance for industry #256 (GFI 256), describing FDA’s position on the legality of compounding animal drugs from bulk...more

Federal Court Deals Blow to FDA’s Compounding MOU

On September 21, 2021, D.C. District Court Judge Christopher Cooper gave an initial victory to the seven compounding pharmacies (“the pharmacies”) challenging Food and Drug Administration’s (“FDA”) final standard Memorandum...more

8 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide