Practitioners Take Huge Risks Dealing With Rogue Drug Compounders

December 2017 | Volume 16 | Issue 12 | Editorials | 1308 | Copyright © December 2017

Sheldon Bradshaw JD

FDA and Life Sciences Practice Group, King & Spalding,Washington, DC

manufacturing in large quantities, a practitioner should make sure that the compounder is lawfully operating as an outsourcing facility prior to sourcing any drugs from them. To do so, there are four FDA-generated lists that a practitioner should consult. The four lists – all of which were prepared by FDA following the passage of the CQA – are easy to access and the exercise is almost always educational (and, more often than it should be, very sobering).1. Make sure that the outsourcing facility is registered with FDA. Lawfully registered facilities are listed here:https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm378645.htmPractitioners may be surprised to learn that a number of compounders manufacturing drugs in bulk have still not registered with FDA as the FD&C Act explicitly requires.2. Make sure that the drug being compounded is either on FDA’s drug shortage list or that the bulk ingredients (ie, active ingredients) are on FDA’s 503B Category 1 list, which can be accessed here:https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/UCM467374.pdfPractitioners may be astonished to learn that many compounded drugs being offered for sale contain an active ingredient that does not appear on the list published by FDA, despite the fact that such products are unlawful. A practitioner should immediately be skeptical about the credibility of an outsourcing facility that offers to compound such drugs.3.Make sure that the compounded drug you want to order is on the list of products that the outsourcing facility has reported to FDA, which can be accessed here under the heading “Product Reporting Information”:https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm393571.htm#reporting.Practitioners may be shocked to learn that the very drug formulations they are being vigorously lobbied to purchase have not been reported to FDA as federal law explicitly requires. In fact, the list published by FDA reveals a large gap between the list of drug formulations that certain outsourcing facilities offer to sell to practitioners and the list of drug formulations those same outsourcing facilities report to FDA. For example, one large outsourcing facility that supplies practitioners with a catalogue listing over 300 unique drug formulations does not have even one single drug formulation on the FDA list. Another large outsourcing facility that on its website touts its ability to compound numerous drug formulations has one (and only one) drug on the FDA list. Offering to compound a drug formulation that the outsourcing facility has not reported to FDA is an obvious red flag that should not be ignored.4. Make sure that the compounded drug you want to order was manufactured in a facility that is in compliance with FDA’s strict cGMP regulations. As noted above, FDA maintains a list of all the outsourcing facilities registered with the Agency at the following easily accessible link:https://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/pharmacycompounding/ucm378645.htm.For each outsourcing facility, FDA has conveniently provided a link to the most recent Form 483 (which contains the inspectional observations made by FDA during a cGMP inspection) and, of critical importance, a link to any Warning or Untitled Letter that FDA issued to the facility due to manufacturing violations. Practitioners may find it sobering to read the inspectional observations contained in a Form 483 or the list of violations enumerated in a Warning or Untitled Letter. It is important to know, however, whether the outsourcing facility from which the practitioner plans on sourcing critical drug products is in compliance with federal law, particularly as it relates to the facility’s ability to compound safe medications. Based on my own experience, a practitioner is unlikely to hear about a compounder’s manufacturing problems during a marketing pitch by the compounder.FDA Commissioner Scott Gottlieb RespondsNotwithstanding the urging of the compounding pharmacy lobby, Dr. Gottlieb is likely to continue to enforce fully the law applicable to compounding. On September 26, 2017, Dr. Gottlieb, who has a long history of seeking to address problems associated with improper drug compounding, issued a statement where he re-emphasized the importance of outsourcing facilities complying with the requirements of the CQA. In so doing, Dr. Gottlieb stressed the importance of outsourcing facilities complying with FDA’s cGMP regulations and specifically encouraged the medical community to only source compounded drugs when FDA-approved alternatives were not available and, even then, only from the lists described above.Following the NECC tragedy, Dr. Gottlieb co-wrote an article (with the author of this paper), “A Compounding Fracture at the FDA,” Wall St. Journal, Nov. 13, 2012, in which he criticized the FDA for failing to use its authority to prevent the tragedy, since it had sent NECC a Warning Letter in 2006. In that WSJ article, he wrote that NECC “was hardly a pharmacy as generally