Compounding Pharmacies
More Information on Pharmacy Compounding
- Petition to the FDA to Amend the List of Drug Products That Were Withdrawn or Removed From the Market Because They Were Deemed Unsafe of Ineffective to Include Hydroxyprogesterone Caproate for Prevention of Preterm Birth, April 27, 2023
- Testimony Before the FDA’s Pharmacy Compounding Advisory Committee Regarding Adding Lorcaserin Hydrochloride to the List of Drug Products Withdrawn or Removed from the Market, June 8, 2022
- Testimony Before the FDA’s Pharmacy Compounding Advisory Committee Regarding the List of Drug Products Withdrawn or Removed from the Market Because They Have Been Found to be Unsafe or Not Effective, June 9, 2021
- Comments on the FDA’s Proposal to Exclude Four Bulk Drug Substances From the 503B Bulks List for Pharmacy Compounding by Outsourced Facilities, May 24, 2021
- Petition to the FDA to Amend the List of Drug Products That Were Withdrawn or Removed From the Market Because They Were Deemed Unsafe of Ineffective, April 13, 2021
- Comments on the FDA’s Proposal to Exclude 19 Bulk Drug Substances From the 503B Bulks List for Pharmacy Compounding by Outsourced Facilities, September 29, 2020
- Comments on the FDA’s Proposal to Amend the List of Bulk Drug Substances That Can be Used to Compound Drug Products Under Section 503A of the FDCA, December 4, 2019
- Comments on the FDA’s Proposal to Exclude Nine Drugs From the 503B Bulks List for Pharmacy Compounding by Outsourced Facilities, November 4, 2019
- Comments on the FDA’s Revised Draft Guidance on Insanitary Conditions at Compounding Facilities, November 26, 2018
- Letter to the Florida Attorney General Regarding Utopia Wellness’s Dissemination of False Advertisements Promoting Cesium Chloride for Treatment of Cancer, November 7, 2018
- Letter to the Director of Medicine at Utopia Wellness Regarding Its Promotion of Cesium Chloride for Treatment of Cancer, November 5, 2018
- Comments on the FDA’s Proposal to Exclude Bumetanide, Nicardipine Hydrochloride, and Vasopressin from the 503B Bulks List for Pharmacy Compounding by Outsourcing Facilities, October 29, 2018
- Letter to the Florida Board of Medicine Regarding the Director of Medicine at Utopia Wellness, Which Promotes and Uses Cesium Chloride for Treatment of Cancer, October 24, 2018
- Letter to the FDA Regarding Utopia Wellness’s Promotion and Use of Cesium Chloride for Treatment of Cancer, October 9, 2018
- Letter to the FTC Regarding Utopia Wellness’s Dissemination of False Advertisements Promoting Cesium Chloride for Treatment of Cancer, October 9, 2018
- Press Statement: FDA Agrees With Public Citizen, Responds to Petition by Taking Action to Prohibit Pharmacy Compounding of Cesium Chloride, July 23, 2018
- Comments on the FDA’s Draft Guidance Regarding Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act, May 25, 2018
- Petition to the FDA to Ban Pharmacy Compounding of Cesium Chloride, December 6, 2017
- Comments on the FDA’s Draft Guidance on Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B, October 11, 2016
- Comments on the FDA’s Draft Guidance on Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A, October 11, 2016
- Comments on the FDA’s Draft Guidances on the Prescription Requirement Under Section 503A and the Facilities Definition Under Section 503 B, July 18, 2016
- Public Citizen Statement to the FDA on Pharmacy Compounding Issues Related to Use of Bulk Substances and Office Stock, June 6, 2016
- Letter to the Texas State Board of Pharmacy Asking the Agency to Shut Down a Dangerous Compounding Pharmacy in Texas, April 6, 2016
- Comments on the FDA’s Draft Interim Policy on Compounding Drugs Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act, December 22, 2015
- Public Citizen asks the FDA to Prohibit Traditional Compounding Pharmacies from Engaging in High Risk Sterile Compounding, March 4, 2014
- Public Citizen Asks the Food and Drug Administration (FDA) to Clarify the Line Between Pharmacy Compounding and Drug Manufacturing, February 3, 2014
- Presentation on Pharmacy Compounding before the Food and Drug Law Institute Enforcement, Litigation, and Compliance Conference, December 18, 2013
- Letter to FDA Commissioner Margaret Hamburg Criticizing Agency Messages Endorsing Compounded Drugs Made by Outsourcing Facilities, December 17, 2013
- Statement: Proposed Compromise Compounding Bill Threatens Patient Safety by Allowing ‘Outsourcing Facilities’ to Manufacture Drugs Without New Drug Approval, September 27, 2013
- Letter to HHS Secretary Sebelius Regarding Specialty Compounding, August 14, 2013
- Public Citizen Comments for House Regarding Compounding Pharmacy Legislation, July 15, 2013
- Public Citizen to Congress: New Bill on Pharmacy Compounding a Major Step Backward for U.S. Drug Safety, May 16, 2013
- Letter to the Editor of The Washington Post Criticizing a Recent Editorial Lauding U.S. Senate Legislation on Compounding Pharmacies, May 12, 2013
- Public Citizen’s Comments on Senate HELP Committee Draft Proposal for Regulatory Oversight of Compounding Pharmacies, May 3, 2013
- Statement to Congress: Proposed Compounding Pharmacy Legislation Would Be a Major Step Backward for U.S. Drug Safety, May 1, 2013
- Letter to FDA Demanding Explanation for Dangerous Delay Between Identifying Problems and Public Recall of Potentially Contaminated Products Distributed by Balanced Solutions Compounding Pharmacy, April 22, 2013
- Letter to the Editor of The Washington Post Criticizing FDA for its Failure to Regulate Drug Manufacturing by Compounding Pharmacies, April 21, 2013
- Comments Submitted to the FDA’s Drug Shortages Task Force, March 14, 2013
- Letter to HHS Secretary Regarding the FDA Commissioner’s Congressional Testimony on Compounded Drugs, December 18, 2012
- Comments to Senate Committee on Health, Education, Labor, and Pensions on the FDA’s Flawed Proposal for Oversight of Compounding Pharmacies, November 30, 2012
- Letter to the FDA Urging Re-Inspection of Compounding Pharmacies with Serious Safety Violations, November 29, 2012
- Letter to the Secretary of Health and Human Services Calling for Expanded Investigation Into Deadly Meningitis Outbreak, November 19, 2012
- Response to Senate HELP Committee’s Questions Regarding Compounding Pharmacies, November 2, 2012
- FDA Still Offering Excuses and Dodging Responsibility for Its Failed Oversight that Allowed Fungal Meningitis Outbreak to Occur, November 2, 2012
- Letter to Secretary of Health and Human Services on FDA Oversight Failures in Light of Meningitis Outbreak, October 24, 2012
- Commentary on CNN.com: Deadly Meningitis Outbreak was Completely Avoidable, October 16, 2012
- Dr. Carome discusses the tainted steroid injections and public health on the Diane Rehm Show, October 10, 2012
- Steroid-Linked Fungal Meningitis Outbreak Reveals Serious Failures in the Oversight of Compounding Pharmacies, October 9, 2012