We have witnessed this past week some noteworthy activity in the drug compounding space. Where will this lead traditional compounders and outsourcing facilities? What will it mean for compounders in the months ahead? We will just have to wait until FDA releases anticipated draft guidance on changes in outsourcing facility compounding in the coming months. FDA’s announcement about draft outsourcing guidance is somewhat of a headscratcher, especially considering that a number of anticipated compounding guidance documents and regulations were recently moved to CDER’s regulatory agenda inactive list (here; search "drug").
Curiosity notwithstanding, Commissioner Gottlieb published a statement on September 26, 2017, addressing FDA’s “new efforts to encourage compounding of better quality drugs” under the Drug Quality and Security Act (DQSA), and provide increased access to compounded medications from outsourcing facilities. First discussing the need for compounded medications, the Commissioner states, “Supporting access to compounded drugs made under high production standards involves helping new outsourcing facilities as they strive to develop expertise in compounding medicines under [cGMP] standards.” Dr. Gottlieb further notes the Agency is committed to “realizing” DQSA’s framework for facilities that register as outsourcing facilities;” thus, FDA is working on a number of efforts “specific to this growing sector as to works to meet these regulatory standards and fulfill its intended role.”
Interestingly, the “growing sector” (based on FDA’s website listing of such facilities) shows that, notwithstanding the four years since the DQSA’s enactment, there are only about 72 outsourcing facilities: FDA has issued Form 483s to all but a few of them, Warning Letters to dozens of them, and engaged in recall activities and shutdowns of many. Around 40 outsourcing facilities have closed their doors since their much anticipated opening after the enactment of the DQSA four years ago.
Nevertheless, Commissioner Gottlieb’s statement shares a Guide, titled “Outsourcing Facility Information,” which he claims may “assist compounders in deciding whether to become outsourcing facilities.,” FDA’s Outsourcing Facility Information Guide is a very general and well-organized primer on Section 503B compounding. It describes in chart form the various requirements in Section 503B, and informs the reader whether there is draft or final guidance, or anticipated guidance or regulations concerning each requirement. The Guide also provides handy links to the various guidance documents that FDA has promulgated addressing compounding under Section 503B over the last four years.
In its attempt to make the outsourcing registration decision as “efficient as possible, FDA’s Guide is “one step in [FDA’s] efforts help more pharmacies become outsourcing facilities. Although we don’t yet know what else FDA intends to do to create these “efficiencies,” Dr. Gottlieb states that FDA will “continue to streamline” the process and “appropriately calibrate the regulatory burden” of operating as an outsourcing facility. The Commissioner concludes: “Our ultimate goal is to make it more feasible” for compounding pharmacies to register to become outsourcing facilities, enabling them to grow their business under a legally approved framework, and increase access to better quality compounded drugs....”
Although not once referenced in the Commissioner’s statement, compounds prepared under the statutory rubric set forth in Section 503A (for individually identified patients pursuant to a prescription or order) are indeed another “legally approved framework” for compounded medications, and there are thousands of such compliant pharmacies operating throughout the United States.
As further demonstration to FDA's commitment to safe compounding, FDA also met with state partners as part of is sixth intergovernmental meeting on drug compounding. This is part of the Agency's continuing effort to provide more seamless coordination between states and FDA in the regulation of compounding. The press release about the meeting addresses targeting oversight by both FDA and states due to limited resources. Noting the varied types of pharmacies across the country - from “mom and pop” pharmacies to those that ship nationwide like conventional drug manufacturers- FDA and states will collaborate to determine which ones should be overseen primarily by states, and the small number of larger pharmacies deserving of FDA oversight. Along these lines, FDA states that it intends to “further enhance our risk-based inspection model to prioritize inspections of compounding pharmacies that operate on a larger scale and ship compounded drugs across multiple state lines.” Thus large volume traditional compounders should consider themselves warned: FDA is paying attention to compounders that ship a lot of product at high volumes across state lines. There is nothing in the press release, however, that discusses the efforts, if any (and unlike reported from other meetings ) to ease the confusing and disparate licensing requirements facing FDA- registered outsourcing facilities . Hopefully creating this “efficiency” is on FDA’s immediate “to do” list
Lastly, FDA published a report, available for your perusal via a link in Dr. Gottlieb’s statement above, setting forth a list of drugs that outsourcing facilities have produced. Note that outsourcing facilities, unlike traditional Section503A compounders, must report to FDA drugs compounded in June and December of each year. The list is a spreadsheet 500 pages long that only includes drugs produced (for those facilities that reported) for the time period between December 2016 and May 2017, including the name of the facility, active ingredient information, package description (and dosage amount), and dosage form.
We will keep you posted on outsourcing facility and compounding developments.
Reprinted with permission.
Karla L. Palmer focuses on DEA and FDA enforcement and litigation matters. Ms. Palmer also advises compounding pharmacies and outsourcing facilities on all aspects of the Drug Quality and Security Act, and has closely followed developments in the law prior to and since its enactment in late 2013. She has advised compounders and outsourcing facilities in investigations, inspections, recalls, shut downs, and responding to FDA Form 493s and warning letters. In addition, Karla is a prolific writer on issues related to compounding and other FDA and DEA matters, and regularly speaks to industry groups on compounding, pharmaceutical supply chain and DEA topics. With 24 years’ trial experience, she also regularly represents clients in investigations, administrative hearings and judicial proceedings.