Take action against FDA restrictions on compounding

In June, legislation was introduced in the U.S. House to make compounded medications more accessible to patients. The bipartisan bill would clarify the Drug Quality and Security Act (DQSA) to balance public safety and patient access. In recent years, FDA restrictions on compounding have severely restricted dermatologists' ability to access and mix preparations.The Academy is urging members to support the Congressional bill to preserve access to compounded medications.

Member to Member recently discussed compounding issues with Seemal Desai, MD, Chair of the Academy’s Leadership Development Committee, incoming director on the Academy's Board of Directors, and alternate delegate to the AMA House of Delegates. Dr. Desai was recently appointed to the US Food and Drug Administration's Pharmacy Compounding Advisory Committee (FDA PCAC).

Member to Member: What are the compounding issues facing dermatologists?

seemal-desai.jpgDr. Desai: Congress passed the Drug Quality & Security Act (DQSA) in response to a meningitis outbreak from contaminated sterile drugs compounded by the New England Compounding Center that resulted in dozens of deaths and hundreds of injuries. The DQSA provided the FDA with oversight authority of a new category (section 503B) of manufacturers, known as “outsourcing facilities,” to regulate manufacturers of larger batches of compounded drugs. While creating this new oversight authority, the DQSA did not authorize the FDA to expand its oversight over physicians and pharmacists.

For decades, dermatologists relied on and safely and effectively used low-risk topical and intralesional office-use compounded drugs to treat patients. However, through the Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act (FDCA) final guidance, the FDA misinterpreted Congressional intent by prohibiting section 503A compounding pharmacies from dispensing office-use compounded drugs without a patient-specific prescription. The FDA incorrectly assumes that section 503B outsourcing facilities can meet the needs of physicians and their patients. However, outsourcing facilities are designed to produce large quantities that make their business models sustainable, rather than the small quantities needed by physician offices. As a result, physicians and patients are facing issues accessing needed drugs.

The word "compounding" gets confused by practicing dermatologists because it can mean many different things. I think we need to clarify what the main compounding issues are. Compounding pharmacists and physicians, including dermatologists, work together to provide patients access to medically necessary treatments. Dermatologists and other physicians obtain compounded drugs from section 503A traditional compounding pharmacies for administration in the clinical setting, which is referred to as “office use.” In what is known as “in-office compounding,” dermatologists and their clinical staff prepare compounded drugs in the office setting.

  • Office use of compounded medications where pharmacies develop therapies for in-office use. Many states are forcing doctors to stop using in-office supplies of treatments such as topical numbing creams, chemical peel treatments, and measles therapy products. Instead, physicians must write individual prescriptions for the same cream even if we have multiple patients coming in on the same day for the same procedure. This is a huge access to care issue because we can’t often get these creams made quickly enough for immediate use. Pharmacies are no longer dispensing these treatments for in-office use because of these restrictions.

  • In-office preparation of compounded medications where physicians compound medications themselves. The majority of dermatologists in practice routinely prepare simple compounds during patient visits. Often we don’t know in advance if a patient will requires in-office treatment until they arrive for an examination, so it is a major inconvenience to the patient when our ability to prepare compound formulas is restricted. By definition, dermatologists really don’t do in-office compounding. But the FDA is now saying that simply buffering lidocaine, for example, qualifies as in-office compounding.

In addition to the FDA regulation, the United States Pharmacopeia (USP), which publishes compounding standards that state legislatures and regulatory boards can adopt, is currently reviewing and potentially revising its Chapter 797 on Pharmaceutical Compounding – Sterile Preparations. USP received more than 8,000 comments on its draft revisions, some of which opposed the burdensome requirements on physicians. Although a new draft is being considered with the potential for additional stakeholder comments, state pharmacy boards are adopting Chapter 797 before it has been finalized.

Dermatologists are being held to the same strict guidelines as large compounding pharmacies, even for low-risk preparations, such as buffering of lidocaine with sodium bicarbonate or dilution of triamcinolone with lidocaine.

We are advocating that dermatologists are not considered preparers of medicine. We’re not really preparing medicine. We’re mixing materials for scientifically proven patient comfort and/or efficacy. What we’re doing as dermatologists by doing lidocaine and bicarbonate or kenalog and saline is mixing. That mixing should not be considered compounding.

TAKE ACTION

Earlier this month, a Congressional bill was introduced to ensure access to medications while maintaining the safety of compounded drugs. HR 2871, a bipartisan bill introduced by Rep Morgan Griffith (R-VA) and Rep. Henry Cuellar (D-TX) clarifies the regulatory authority of the FDA. 

Send a letter to your Congressperson in support of the bill on the Academy's DAN website.

CONTACT YOUR REP



MTM: What is the AADA doing to advocate against FDA restrictions on compounding?

Dr. Desai: The Academy is working very hard to preserve access to all forms of compounding. We are working with Congress to introduce legislation that would prevent the FDA from overreaching requirements set by the DQSA.
The DQSA requirements do not cover many of the restrictions proposed by the FDA. For example, our ability to mix lidocaine is not restricted under the DQSA. Our legislation says that the tenants of the DQSA should be followed and the FDA should not have the authority to overreach beyond the DQSA.

Josephine Nguyen, MD, Deputy Chair of the Academy's Regulatory Policy Committee, recently spoke at an FDA listening session on compounding June 6 that focused mostly on in-office compounding.

MTM: What can members to do fight against these restrictions?

Dr. Desai: We’re calling on all dermatologists to join this effort. I urge all Academy members to listen in on FDA open hearings on compounding issues, which are available on the FDA website. And then write to your elected officials explaining why you oppose the restrictions.

Also, make sure these issues are being addressed by your state medical society. Restrictions vary widely state-by-state and it’s essential that you advocate at the local level to protect your rights. Many state legislatures and boards of pharmacy have mirrored FDA’s interpretation of the DQSA. As a result of FDA and state actions, access issues have resulted for physicians and their patients for much needed treatments.  

Members also should be concerned about the overreach of state pharmacy boards into physician offices. Because physicians are regulated by the state medical boards, which have the authority to investigate and take appropriate disciplinary action, physicians should not also be subject to the pharmacy board regulations and oversight. As an example, the Ohio State Board of Pharmacy adopted prescriptive rules regarding how physicians can compound drugs in their office. Such rules are creating obstacles to care and are increasing costs to patients. Many physician offices are discontinuing the practice of compounding medications altogether as a result.


If you are having difficulties accessing compounding drugs for office use from a Section 503B outsourcing facility or if you have other compounding-related concerns, please contact AADA staff at npattanshetti@aad.org.