Today, President Donald J. Trump signed into law H.R. 244, which provides fiscal year 2017 full-year appropriations through September 30, 2017, for all agencies except those covered by other legislation.
In a win for APhA, bipartisan congressional legislation that will keep the government open includes language that clarifies congressional intent on several compounding regulations implementing the Drug Quality and Security Act (DQSA) of 2013. The regulations addressed are among those on which APhA and other pharmacy organizations had asked FDA for additional clarity. The law instructs FDA to draft new guidances in areas where the agency had misinterpreted the intentions of Congress.
The language calls on FDA to do the following:
Draft a new memorandum of understanding (MOU) that allows pharmacies that meet all other requirements of 503A to “distribute” compounded products over state lines.
APhA and other pharmacy organizations had expressed concern over previous draft MOU language putting pharmacies at risk of losing 503A status and being subject to state and FDA investigation if they distributed an “inordinate amount” of compounded drug products interstate, warning that the murky limits could impede patient access to needed drugs.
The law clarifies that Congress did not intend to redefine “distribution” to include “dispensing,” specifying that Congress only intended FDA to regulate “distribution”—not "dispensing” to a patient over state lines.
Draft new guidance to allow pharmacists to compound for “office use” in anticipation of receiving patient-specific prescriptions at a later time.
Recently, FDA issued final 503A compounding guidance prohibiting office use. That final guidance would have required pharmacists to obtain a valid “patient-specific prescription” for each drug compounded under Section 503A of the DQSA, despite existing federal law stating that a licensed pharmacist can compound “in limited quantities before the receipt of a valid prescription order for such individual patient.” Previously, APhA and other pharmacy organizations had expressed concern that confusion about if, when, and how office-use compounding was permissible could prevent patients from getting the compounded products they need.
The law clarifies that Congress intended to allow compounders to compound a batch of drugs in anticipation of receiving patient-specific prescriptions and instructs FDA to draft new guidance allowing compounding for office use to continue.
Acknowledge that pharmacies compounding under 503A are the purview of state boards of pharmacy and are not to be held to current Good Manufacturing Practices (cGMPs).
APhA and other pharmacy organizations had expressed concern that, under previous FDA guidance, pharmacies compounding under Section 503A were being inspected using federal oversight of cGMPs—traditionally reserved for drug manufacturers—instead of the long-established use of USP standards for sterile and nonsterile compounding.
The law mandates that FDA recognize that federal oversight of 503As was not the intent of Congress, and that compounding pharmacies are not drug manufacturers—rather, they are “state licensed and regulated health care providers that are inspected by state boards of pharmacy pursuant to state laws and regulations that establish sterility and other standards for the pharmacies operating within their states.”