Drugs

Regulatory Policy Information

Date IssuedTypeTitleAdditional Information
4/15/2016Draft GuidancePrescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic ActNotice of Availability
4/15/2016Draft GuidanceHospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic ActNotice of Availability
4/15/2016Draft GuidanceFacility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic ActNotice of Availability
10/26/2015Final GuidancePharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance (PDF - 86KB)N/A 
10/26/2015Draft GuidanceInterim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act Guidance for Industry (PDF - 105KB)Notice of Availability
10/26/2015Draft GuidanceInterim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry (PDF - 126KB)Notice of Availability
10/26/2015Request for NominationsBulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503B of the Federal Food, Drug, and Cosmetic Act; Establishment of a Public DocketN/A
10/26/2015Request for NominationsBulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act; Establishment of a Public DocketN/A
10/8/2015Final GuidanceNotice of Availability
8/12/2015Final GuidanceGuidance For Entities Considering Whether to Register As Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic ActNotice of Availability
8/3/2015FR NoticeOutsourcing Facility Fee Rates for Fiscal Year 2016 N/A 
3/6/2015Public DocketCompounding of Human Drug Products Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act; Establishment of a Public DocketN/A
2/13/2015Draft MOUDraft Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products Between the State of [insert STATE] and the U.S. Food and Drug Administration Notice of Availability 
2/13/2015Draft GuidanceRepackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities Notice of Availability
2/13/2015Draft GuidanceMixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application Notice of Availability

11/24/2014

Final Guidance

Fees for Human Drug Compounding Outsourcing Facilities Under the FD&C Act

Notice of Availability 

11/24/2014

Final Guidance

Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act

Notice of Availability

11/24/2014

Revised Draft Guidance

Electronic Product Reporting for Human Drug Compounding Outsourcing Facilities

Notice of Availability

7/2/2014

Request for Nominations

Bulk Drug Substances that May be Used to Compound Drug Products in Accordance with Section 503A of the Federal Food, Drug, and Cosmetic Act; Revised Request for Nominations 

N/A

7/2/2014

Request for Nominations

Bulk Drug Substances That May Be Used To Compound Drug Products in Accordance With Section 503B of the Federal Food, Drug, and Cosmetic Act, Concerning Outsourcing Facilities; Revised Request for Nominations 

N/A

7/2/2014

Proposed Rule

Additions and Modifications to the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness 

N/A

7/2/2014

Draft Guidance

Current Good Manufacturing Practice-Interim Guidance for Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug and Cosmetic Act 

Notice of Availability

12/4/2013

Request for Nominations

List of Bulk Drug Substances That May Be Used in Pharmacy Compounding; Bulk Drug Substances That May Be Used to Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act; Request for Nominations 

N/A

12/4/2013

Request for Nominations

Bulk Drug Substances That May Be Used to Compound Drug Products in Accordance With Section 503B of the Federal Food, Drug, and Cosmetic Act Concerning Outsourcing Facilities 

N/A

12/4/2013

Request for Nominations

Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act 

N/A

 

 

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