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Take Action to Protect Patient Access to Compounded Medications

FDA, Regulatory Issues

This past week, there were 2 developments in Washington, D.C. related to pharmacy compounding (scroll down for details):

  1. H.R. 1959, the Preserving Patient Access to Compounded Medications Act of 2019, was reintroduced in the House of Representatives
  2. Congressmen Peter Welch (D-VT) and Morgan Griffith (R-VA) drafted a letter to FDA asking that the agency correct the definition of distribution in the reissued MOU so that it does not include patient specific dispensing

PCCA members will be in D.C., April 9-10, for the 7th Annual ACT Legislative Conference, calling on lawmakers to support patient access to compounded medications. If you can’t join us at ACT, we need your help in contacting your Representatives now on these 2 opportunities to help patients. Please review the following information and contact your Congressional Representatives’ offices now.

Find your Congressional Representatives. Then call the Congressional switchboard at 202.224.3121 and ask to speak with your Congressional Representatives’ offices. Once connected, ask for the health legislative assistant. See below for speaking points.

 

Compounding Legislation Reintroduced in U.S. House of Representatives

Reps. Morgan Griffith (R-VA) and Henry Cuellar (D-TX) reintroduced legislation that would allow more meaningful patient access to compounded medications: H.R. 1959, the Preserving Patient Access to Compounded Medications Act of 2019. The legislation addresses FDA’s implementation of the 2013 Drug Quality and Security Act, which has resulted in limiting and in some cases denying access to compounded medications for many patients and prescribers.

Major components of the legislation:

  • Allows office use compounding consistent with state law.
  • Clarifies that pharmacies dispensing medication pursuant to a patient specific prescription are not impacted by the Memorandum of Understanding (MOU). As background, FDA’s current draft proposal to implement the MOU includes an overly broad definition of distribution that also includes the dispensing of medications across state lines.
  • Clarifies that the definition of a USP or National Formulary monograph includes both drugs and dietary supplement monographs. Currently FDA is taking the position that only drug monographs may be compounded.
  • Clarifies that during the inspection process, the current records exemption applies to all pharmacies including compounding pharmacies.

TAKE ACTION NOW

  • Contact your reps and explain that this bipartisan legislation was recently introduced
  • Explain any current patient access barriers you, your prescribers or your patients are experiencing, and why the legislation would help. For example:
    • How the FDA’s current prohibition on medications compounded for office use is barring access for your prescribers and patients.
    • The legislation clarifies that the definition of distribution does not include dispensing. This is important for pharmacies licensed in more than one state because FDA’s revised draft MOU contains an overly broad definition of distribution, which includes the dispensing of patient specific medications. In states that do not enter into an MOU with the FDA, pharmacies could only send 5% of their prescriptions to patients outside their state, which would severely limit access. Fixing the definitions would alleviate many potential access barriers.
    • Ingredients with dietary supplement monographs can no longer be compounded because the agency is limiting monographs to only drug substance monographs, thus excluding dietary supplement monographs. The only exceptions to this are substances on FDA’s “positive list” of ingredients that can be lawfully compounded, or ingredients on list 1 of FDA’s Interim Guidance on Bulk Substances for 503A Pharmacies.
  • Ask the staffer if your Congressman will cosponsor the legislation and thank them for researching the proposal.
  • Mark your calendar and make a note to follow up with the staffer in about 2-3 weeks to determine if further information is needed.

U.S. SENATE OUTREACH

You can also contact your U.S. Senators and ask them to introduce companion legislation to H.R. 1959. Call the Congressional switchboard and ask to speak with your Senator’s heath legislative aide.

 

Serving Patients in Other States by Sending Their Prescriptions to Them?

Congressmen Welch and Griffith have drafted a letter to the FDA asking the agency to correct the definition of “distribution” so that it does not include patient specific dispensing. The letter explains that FDA’s current definition of distribution contradicts industry precedent as well as current law. Under the current MOU proposed by FDA, all prescriptions that are dispensed would be counted as being distributed. When the time comes for your state to decide if it will sign the MOU, you may be limited to sending out only 5% of your compounded prescriptions to patients in other states if your state does not sign the MOU.

TAKE ACTION NOW

  • The letter is open for other lawmakers to sign.
  • Contact your reps today and ask them to sign the Welch – Griffith letter to FDA to maintain patient access to the pharmacy of their choice, no matter where they live.
  • Explain that the FDA’s current definition of “distribution” is overly broad and would limit patient access if left in current form.
  • Your Congressional office can contact either Congressman Welch’s office or Congressman Griffith’s office to sign the letter, or for additional information. Note: the letter is open for only lawmakers to sign, not outside organizations or private companies. 

Have questions or want more information? Contact us at publicaffairs@pccarx.com.

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