Compounding: Patient-Specific Requirements on 503As
In 2012, a fungal meningitis outbreak linked to tainted sterile compounded drugs transformed the compounding industry by prompting the U.S. Food and Drug Administration (FDA) to tighten regulations on compounding pharmacies and spurred state pharmacy boards to review their compounded medication regulations. Numerous state boards of pharmacy began requiring individual patient prescriptions for compounded medical orders putting access to sight-saving Bevacizumab (Avastin®) in limbo for patients relying on it for effective off-label treatment for age-related macular degeneration (AMD) and other conditions, as well as limiting prompt access to other needed treatments.
Drug Quality and Security Act
In 2013, the Drug Quality and Security Act was signed into law, creating a new category of more highly regulated compounding pharmacies known as ‘outsourcing facilities’ (or 503Bs) and giving the FDA new oversight authority for the compounding of prescription medications. As part of their enforcement of the law, in 2016, the FDA published draft guidance limiting compounding of non-patient specific drugs for physicians, hospitals and clinicians to FDA-regulated outsourcing facilities (503Bs), limiting traditional pharmacies (503As) to compounding only after receiving a valid prescription for an individual patient, and placing a geographic restriction on an exception for emergency treatment. Physicians face very real logistical hurdles in providing timely treatment with personalized drugs not compounded by 503B facilities.
ASRS provided in-person testimony as well as formal written comments to the FDA regarding these draft guidance documents on compounding making the following key points:
- Assure access to drugs without patient-specific prescriptions for in-office emergency treatment of conditions, such as fungal endophthalmitis, when such drugs cannot be obtained from 503B facilities.
- Eliminate the one-mile restriction on where hospital compounding pharmacies can distribute compounded drug products without first receiving a patient-specific prescription.
ASRS urged the FDA to make these critical revisions in final guidance so that retina specialists can ensure appropriate emergency vision-saving treatment for their patients.
FDA Comment Letters
- ASRS Comments: Regulations Governing Drug Compounding -- June 2017
- ASRS Comment Letter: Guidance on Repackaging -- March 2017
- ASRS Comments on Prescription and Hospitals and Health System Compounding Requirements Under FDA Draft Guidance --July 2016
- ASRS Comments on FDA Draft Guidance on Mixing, Diluting or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application -- May 2015
Click blue links for information
- FDA Invites ASRS to Weigh In on Regulations Governing Compounding Jun. 7, 2017
- FDA Issues Long-Awaited Final Guidance on Compounding (503A) Pharmacies Dec. 29, 2016
- ASRS Calls on FDA to Remove Obstacles in Draft Compounding Guidance - July 20, 2016
- As Compounding Obstacles Increase, ASRS Voices Concerns and Additional Recommendations to New FDA Compounding Chief - June 8, 2016
- ASRS to Comment at Upcoming FDA Listening Session on Drug Compounding - June 1, 2016
- New FDA Guidance Requires Patient-Specific Prescriptions for Drugs Compounded by Traditional Compounders for Office Use - April 20, 2016
- ASRS submits its official comment letter to FDA - May 19, 2015
- ASRS Joins Coalition Effort to Allow States to Govern Office Use of Compounded Drugs - March 2015
- FDA releases ‘Draft Guidance on Mixing, Diluting or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application' - February 13, 2015
- ASRS attends FDA public forum with other physician groups - June 26, 2014
- Ophthalmology Fighting for a Seat at the Table as FDA Implements Compounding Regulations - February 16, 2014
- ASRS Urges Congress to Protect Patient Access to Compounded Drugs - December 23, 2014
- ASRS Launches Updated Compounding Pharmacy Questionnaire to Assist Members in Evaluating Compounders - September 24, 2014
- Despite Guidance Setback, ASRS Continues to Push for Access to Avastin - July 9, 2014
- FDA Guidance on Compounded Drugs Limits Distribution for Office Use to Approved Outsourcing Facilities - July 2, 2014
- ASRS Call to Action: Ask Congress to Support Letter to FDA on Pharmacy Compounding - June 19, 2014
- Obama Signs Drug Quality and Security Act, creates a new category of compounding pharmacies known as "outsourcing facilities” or “503bs” and gives FDA new authority over the compounding of prescription medications. - November 30, 2013
- CDC and FDA Caution Retina Specialists: Stop Using Drugs from New England Compounding Center - October 8, 2013
- Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act
- Facilities Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act
- Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act
- Insanitary Conditions at Compounding Facilities