NHIA urges you to reach out to your members of Congress to request they cosponsor the Preserving Patient Access to Compounded Medications Act (PPACMA). Please click here to send a letter to your members of Congress on this vital legislation.
NHIA supports the PPACMA, introduced by Congressmen Morgan Griffith (R-VA) and Henry Cuellar (D-TX). This legislation will clarify the federal regulatory role in traditional compounding pharmacy. Since passage of the Drug Quality and Security Act (DQSA) in 2013 there has been a lack of understanding about where federal regulatory oversight of traditional compounding pharmacies begins and ends. Specifically, there are questions regarding the dispensing of compounded product over state lines, inspection standards, and various other provisions.
Important to NHIA and the home and specialty infusion field is clarification of the application of a provision in the DQSA that calls for a Memorandum of Understanding (MOU) between the U.S Food and Drug Administration (FDA) and states regarding the distribution of compounded products over state lines. NHIA has been actively working to ensure that the PPACMA includes a provision to clarify that dispensing over state lines should not be subject to the MOU. NHIA has long argued that dispensing a compounded product to an individual patient pursuant to a prescription is not commonly considered distribution of the product under state and federal law.
The FDA, in its draft MOU released in 2015, included dispensing as an act of distribution. This would have serious implications for home infusion providers since the common business practice of dispensing medications for administration in a patient’s home can occur across a state line from the physical site where the drug is compounded. Specifically, a home infusion pharmacy could not dispense more than 30% of its compounded products over state lines, which would hinder patient access to life-saving medications. This is of particular concern in metropolitan areas and population regions that cross over state lines. We are pleased that the PPACMA will address a long-standing problem with the MOU that NHIA has fought to resolve over the past several years. We know that Congress did not intend to have this provision halt the delivery of home infusion therapy by a provider licensed in the patient’s home state, but whose home infusion pharmacy is in another state. This legislation will once and for all clarify the issue in statute and ensure patients have access to home infusion therapy.
The PPACMA also includes other compounding pharmacy clarifications including: