Food and Drug Administration

Since our  March 17th post about President Trump’s executive actions aiming to implement his deregulatory agenda, several important developments related to the so-called “2-for-1” Executive Order (E.O. 13,771) have occurred at the Executive Branch management level.  In addition, of great interest to us is the fact that the Food and Drug Administration (FDA) took its first major public step toward implementing the goals laid out in the President’s directive. On September 8th, the FDA issued seven Requests for Information that solicit “broad public comment on ways [FDA] can change [its] regulations to achieve meaningful burden reduction while continuing to achieve [its] public health mission and fulfill statutory obligations.” As detailed below, FDA issued one notice for each major product-focused Center, and one specific to cross-cutting agency regulations.

This post outlines the backdrop for–followed by the details of–FDA’s public request for input about which regulations should be cut or modified. Continue Reading FDA Takes First Steps to Cut Regulations, Solicits Public Feedback

Last month, FDA released three draft guidance documents that are expected to have significant implications for traditional pharmacy-based compounding and the distribution of those drug products.

First, however, a little bit of historical context might be helpful.  As previously reported here and widely known in health care circles, in late 2013 Congress passed a law called the Drug Quality and Security Act (DQSA).  Among other things, DQSA created a new class of federally regulated drug compounders called “outsourcing facilities” and also clarified requirements for compounding by licensed pharmacists and physicians in compliance with the Federal Food, Drug, and Cosmetic Act.  In the 2.5 years that have elapsed since enactment of the law, FDA has been busy implementing its new authority over outsourcing facilities and issuing guidance for those entities, such as how current Good Manufacturing Practice (cGMP) regulations will apply to them and how they should go about registering and paying a required annual establishment fee. The three draft policies issued in mid-April address issues that affect both outsourcing facilities and State-licensed pharmacies that compound drugs on behalf of health care practitioners who need customized, non-commercially available products for specific patients.  The policies address, for example, what constitutes a “prescription” for a compounded drug; how much product can be prepared in anticipation of receiving future prescription orders; and how large hospital or health system pharmacies may distribute compounds to other areas of the facility in advance of receiving a patient-specific order. Continue Reading New Compounding Policies from FDA May Affect Hospital and Health System Pharmacy Operations

Written by: Roy Albert

Last week, Democrat and Republican leaders of both houses of Congress agreed to the terms of a bill that would give the U.S. Food and Drug Administration (FDA) greater authority to regulate drug compounding and would revamp the way drugs are tracked from the manufacturer to the pharmacy.  The House of Representatives voted in favor of the bill shortly after the agreement was announced.  The bipartisan agreement comes at a time when compromise between the two major political parties has been rare and fights over the federal budget and raising the “debt ceiling” have become commonplace.  Congress’s failure to agree on a spending bill has resulted in the first government shutdown since 1995-1996.

The Drug Quality and Security Act (Act) would give the FDA oversight authority over large-volume compounders who elect to register as outsourcing facilities.  The FDA’s oversight of such compounders would be similar to the manner in which the FDA regulates traditional drug manufacturers.  Those compounders that elect to remain as traditional pharmacies would continue to be regulated by state boards of pharmacy.

Continue Reading Bipartisan Agreement Reached on Legislation Granting FDA Greater Authority to Regulate Drug Compounders

Written by Kim Gold

The Food and Drug Administration has taken its first action against a mobile app maker for failure to obtain pre-marketing clearance. Late last week the FDA sent a letter to Biosense Technologies Private Limited, asking the company to either identify an FDA clearance for its uChek urine analyzer app or explain why it does not believe that FDA clearance is required. According to the FDA, the uChek app, which allows users to check urinalysis results by taking photos of test strips, and a mobile phone function together as an automated strip reader that requires 510(k) clearance as a “urinalysis test system” because the app allows the phone to be used to analyze the test strips.

Continue Reading FDA Delivers Its First Mobile Medical App Inquiry