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

essentially a copy of one or more approved drugs. Outsourcing facilities must also, among other things: (1) register with FDA, (2) comply with the FDA’s stringent cGMP regulations; (3) open its operations to FDA inspections; (4) report adverse events to the FDA; and (5) provide the FDA with detailed information about the products they compound. If an outsourcing facility comports with all of the requirements contained in Section 503B, the product need not have labeling that contains adequate directions for use or obtain FDA drug approval prior to marketing.Risks to Patient Health Posed by Illegally Compounded ProductsDespite the passage of the CQA following the NECC tragedy, rogue actors still persist in mass manufacturing and marketing compounded drugs without complying with either of the two legal pathways or FDA’s drug manufacturing requirements. This unlawful practice continues to expose countless patients to experimental and potentially dangerous products.FDA has repeatedly cautioned that although legally compounded drugs “can serve an important need, they also pose higher risks to patients than FDA-approved drugs. Compounded drugs are not FDA-approved, which means they have not undergone FDA premarket review for safety, effectiveness, and quality.” FDA has further cautioned that “[t]here can be health risks associated with compounded drugs that do not meet federal quality standards. Compounded drugs made using poor quality practices may be sub- or super-potent, contaminated, or otherwise adulterated. Additional health risks include the possibility that patients will use ineffective compounded drugs instead of FDA-approved drugs that have been shown to be safe and effective.”The dangers of illegal compounding are also underscored by two risk alerts recently issued by FDA. On August 4, 2017, FDA announced that a compounded curcumin injectable product has been associated with two serious adverse events, including one death. In addition, on July 28, 2017, FDA announced that it had received adverse event reports for at least 43 patients who had invitreal (eye) injections of a compounded mixture of triamcinolone and moxifloxacin during cataract surgery. The adverse events included blurred and decreased vision.Because compounded products are not subject to FDA pre-approval, FDA is often unaware of violative and dangerous products until they have actually injured patients. The government can take action at the time, but often it is too late to protect patients. For example:• In June 2017, the owner and head pharmacist of the NECC was sentenced to nine years in prison after causing a 2012 multistate meningitis outbreak that sickened over 750 individuals and resulted in 64 deaths. The government also indicted at least 14 others in connection with the outbreak.• In June 2017, the owner and compliance director of an Indiana compounding pharmacy were indicted in connection with their distribution of over- and under-potent drugs, including the opioid morphine sulfate that was nearly 25 times the correct potency – the super-potent drug was administered to three infants at a hospital, and one had to be taken by emergency helicopter to a nearby children’s hospital.• In July 2017, a U.S. District Court in Alabama entered a permanent injunction against a compounding pharmacy and its executives. The Justice Department said the pharmacy failed to adequately address insanitary conditions that resulted in contaminations in sterile areas. The government’s investigation was prompted in part by a 2015 outbreak of staphylococcus aureus infections that were potentially linked to products manufactured by the pharmacy.• In April 2017, a court entered a preliminary injunction against a pharmacy after dozens of patients in the Dallas area were harmed by antibiotic injections used in “dropless” cataract surgeries. Several patients lost vision in one eye, and immediate malpractice litigation was launched against the ophthalmologist and his practice as a result of the event.• In June 2016, two pharmacists from a compounding pharmacy in Alabama were sentenced to prison, following a 2011 outbreak in which 19 cases of serratia marcescens bacterial infections were reported, including nine deaths, associated with contaminated IV nutrition formula from the pharmacy.Risks to Practitioners’ Practices Posed by Illegally Compounded ProductsThe publicity surrounding the tragedy caused by NECC in 2012 rightfully focused on the impact to the public health. But following the passage of the CQA, these tragedies can put practitioners at risk too. Drug products that are unlawfully mass manufactured and marketed under the guise of compounding are adulterated and misbranded, and the FD&C Act prohibits their sale and use. As a result, violators may be subject to criminal prosecution and sanctions under FD&C Act. In addition, practitioners may be subjected to the loss of a medical license and patient lawsuits. The use or sale of unlawfully compounded drugs could also give rise to civil liability under patent or other laws.Moreover, the rogue compounders have tried to scapegoat practitioners. For example, in reaction to FDA’s risk advisory regarding the curcumin emulsion, the compounding pharmacy quickly blamed the practitioner, stating in a press release that one event was related to “the apparent improper administration