Pharmacy Compounding

The Practice of Pharmacy Compounding

Welcome to CDER's Internet page on pharmacy compounding. CDER has created this page so readers can follow the Agency's activities on pharmacy compounding. Additional documents and information will be added as they become available.

FDA Modernization Act

• Section 127, Application of Federal Law to Practice of Pharmacy Compounding
• Court Decision - Western States Medical Center v. Shalala, 99-17424, February 6, 2001 (Posted 2/12/01)
• Supreme Court Decision - Thompson et al. v. Western States Medical Center et al., U.S. Supreme Court Case No. 01-344, Decided April 29, 2002.   (Posted 5/20/2002)

Guidance for Industry

• Guidance for FDA Staff and Industry, Compliance Policy Guides Manual, Sec 460.200, Pharmacy Compounding. [HTML] or [PDF]. (Posted 6/7/2002).  Federal Register Notice Announcing the Availability of the Pharmacy Compounding Compliance Policy Guide [HTML] or [PDF] (Posted 6/7/2002). 
• FDA Concept Paper: Drug Products That Present Demonstrable Difficulties for Compounding Because of Reasons of Safety or Effectiveness [HTML] (6/29/2000)
• Letter Extending the Comment Period for the Concept Paper (8/14/2000)

Pharmacy Compounding Committees

• Termination of Pharmacy Compounding Advisory Committee [HTML] or [PDF]   (Posted 1/14/2003)
• Pharmacy Compounding Steering Committee Members (Updated 5/14/99)
• Pharmacy Compounding Advisory Committee Members (Updated 5/12/99)

Pharmacy Compounding Advisory Committee Meetings

• May 6-7 1999 Agenda and Presentations
• July 13-14, 2000 Notice of Meeting [Text] or [Acrobat] (7/10/2000)

Federal Register Notices

• Federal/State Memorandum of Understanding on Interstate Distribution of Compounded Drug Products; Draft; Availability (Notice) [Text] or [PDF] and (Draft MOU) (Issued 1/21/99, posted 1/21/99)
• Federal/State Memorandum of Understanding on Interstate Distribution of Compounded Drug Products; Draft; Availability; (Reopening of Comment Period) [Text] or [PDF] (Posted 6/23/99)
• List of Bulk Drug Substance That May Be Used in Pharmacy Compounding; Preliminary Draft Proposed Rule; Availability (Notice) [Text] or [PDF] and (Draft Proposed Rule) [PDF] (Issued 10/14/98) (See Regulations Section for the Proposed Rule that Issued on 1/7/99.)
• The Pharmacy Compounding Advisory Committee Meeting has been rescheduled for May 6-7, 1999 (in the CDER Conference Room at 5630 Fishers Lane, Rockville). The agenda includes discussion of the following drug substances as candidates for the bulk drugs list: 4-aminopyridine, 3,4-diaminopyridine, betahistine dihydrochloride, chloramineT, cyclandelate, dinitrochlorobenzene, diphenylcyclopropenone, hydrazine sulfate, mild silver protein, monosodium asparate, pentylenetetrazole, peruvian balsam, and squaric acid dibutylester.
• Pharmacy Compounding Advisory Committee; Notice of Meeting.  Pages 19791-19792 [FR Doc. 99-10076][HTML] or [PDF]
• Request for Nominations for Inclusion on the Bulks Drugs List, Federal Register Notice (published 4/7/98)

Regulations

• List of Bulk Drug Substance That May Be Used in Pharmacy Compounding (Proposed Rule) [Text] or [Acrobat] (Issued on 1/7/99)
• List of Drug Products That Have Been Withdrawn or Removed from the Market for Reasons of Safety or Effectiveness: Proposed Rule (10/8/98)
• List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness: Final Rule [HTML] or [PDF] (Updated 3/9/99)

Public Presentations

• Report: Limited FDA Survey of Compounded Drug Products (posted 2/13/2003)
• FDA Presentation at the National Association of Boards of Pharmacy, Annual Meeting, May 24, 1999 (6/1/99)

Links to Other Information

• FDAMA Docket on Pharmacy Compounding
• CDER FDA Modernization Act Page
• FDA Modernization Act Page

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FDA/Center for Drug Evaluation and Research
Last Updated: February 14, 2003
Originator: OTCOM/DLIS
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