Legislative Advocacy
- ASHP Statement for the Record: "Examining Implementation of the Compounding Quality Act" [1/30/18]
- Drug Quality and Security Act: Section 503A of the Food Drug & Cosmetic Act [PDF - 11/18/13]
- Drug Quality and Security Act: Section 503B of the Food, Drug, & Cosmetic Act [PDF - 11/18/13]
- ASHP Testifies on Legislation Reforming Drug Compounding [PDF - 7/16/13]
- ASHP Testimony: U.S. Senate Committee on Health, Education, Labor, and Pensions Hearing - Pharmacy Compounding: Proposed Legislative Solution [PDF - 5/9/13]
Regulatory Advocacy
- ASHP Submits Comments to USP on the Proposed Revision to General Comment <795> [03/17/2022] (PDF)
- ASHP Submits Comments to USP on the Proposed Revision to General Comment <797> [03/17/2022] (PDF)
- ASHP Responds to FDA's Request for Comments on Compounding Guidance [12/06/21]
- Issue Brief: FDA Revised Hospital and Health System Interim Draft Guidance [10/06/2021]
- ASHP Comments in Response to Public Meeting on 503B Outsourcing Facilities Office Stock [6/21/19]
- ASHP Comments on Good Manufacturing Practices for 503B Facilities [2/11/19]
- ASHP Comments on Proposed Revisions to USP General Chapter <797> [11/29/18]
- ASHP Comments on FDA Proposed Exclusions from 503B Bulks List [10/29/18]
- ASHP Comments on Proposed Revisions to USP General Chapter <795> [7/30/18]
- ASHP Comments on FDA Draft 503B Bulks List Guidance [5/25/18]
- ASHP Comments on 2018 NIOSH Hazardous Drug List [6/19/18]
- ASHP Comments on FDA Guidance on Copies of Commercially Available Drugs under 503 A [PDF - 10/11/16]
- ASHP Comments on FDA Guidance on Copies of Commercially Available Drugs under 503 B [PDF - 10/11/16]
- Compounding Guidances Frequently Asked Questions [PDF - 4/27/19]
- ASHP Urges FDA to Make Changes to Draft Compounding Guidances Released in April 2016 [6/18/16]
- The Impact of FDA’s New Compounding Guidance: A Primer [PDF - 11/3/2016]
- ASHP Comments on Proposed FDA-State Memorandum of Understanding [PDF - 7/20/15]
- Regulatory Alert: FDA Issues Three Guidances on Pharmacy Compounding [4/18/16]
- Regulatory Alert: CMS Updates Compounding Guidance for Critical Access Hospitals [PDF - 11/3/2016]
- Issue Summary: Office of Inspector General Report on Medicare Oversight of use of Compounded Medications in Hospitals [PDF - 2/2/15]
- ASHP Comments to FDA on Section 503A [PDF - 2/3/14]
