Changes in the Pharmaceutical Industry Lead to New Challenges for Pharmacists

As the pharmaceutical industry changes, the laws and regulations that apply struggle to keep up with the new issues that continually arise.  One of the biggest transformations in the drug landscape is the growth of the compounding drug companies that operate across state lines and mix relatively small batches of drugs with very little regulation. This industry has played a prominent role in the mounting controversy surrounding lethal injections in death penalty cases.

An Oklahoma compounding company, sometimes referred to as a compounding pharmacy, was at the center of a recent lawsuit filed by attorneys for death row inmate Herbert L. Smulls that alleged the lethal injection drugs being stored by the Missouri Department of Corrections were expired and the Oklahoma pharmacy that provided the drugs did not possess a license to do business in Missouri.  The lawsuit requested that the Oklahoma State Board of Pharmacy recall the batch of pentobarbital that was sent to Missouri by an Oklahoma compounding company.  The lawsuit also alleged that the Missouri prison officials had not stored the drugs properly.

In opposition to the lawsuit, the Oklahoma pharmacy board argued that the compounding pharmacy had not violated any laws because it did not ship the drug to Missouri, but rather someone from Missouri had come to Oklahoma to pick up the drug.  Part of the counter-argument also included the assertion that it was impossible for every pharmacy obtain licensure in all fifty (50) states so common sense allowed for some latitude.  The Missouri Board of Pharmacy did not take any action on the complaint, finding that the Board did not have jurisdiction over entities that take possession of drugs from other states, only those people or entities that distribute or dispense prescriptions in Missouri.

Although this is a unique situation, it does highlight the fact that pharmacists must remain aware of what is happening across the country with regard to compounding companies and other changing rules.  Compounding companies pose a particular problem because approximately 3,000 of them operate in the United States, while only fourteen (14) have signed up voluntarily to be regulated by the Food and Drug Administration (FDA) pursuant to the newly-enacted Drug Quality and Security Act.  The FDA has initiated a campaign recently to urge healthcare providers to demand compounding pharmacies sign up for regulation in order to improve the quality of drugs available to the public.

The Drug Quality and Security Act permits compounding pharmacies that mix sterile drugs and ship these drugs across state lines to register as with the FDA as outsourcing facilities rather than submitting to the regulation of state pharmacy boards.  Once a compounding pharmacy has registered with the FDA, it must submit to inspection of its facilities and agree to report any problems with the mixing of products.  While this does create a new burden for compounding pharmacies, it also will enhance long-term business by building a more reputable practice model.

As a pharmacist working in Missouri or Kansas, it is necessary to monitor these new regulations in order to remain in compliance with the terms of your license.  If you have learned of an investigation into your behavior that may lead to a disciplinary action, regardless of the origin of the complaint, it is critical to be proactive in protecting your license.  Skilled pharmacist license defense attorney Danielle Sanger can help you protect your livelihood.

The Sanger Law Office Offers License Defense Strategies for Pharmacists

Pharmacists face many scenarios every day that could lead to an investigation into their licenses simply because of the complex nature of filling prescriptions, including mixing drugs.  If something happens that may jeopardize your license, it is important to take immediate action to limit the consequences.  Danielle Sanger of the Sanger Law Office understands the trauma that a disciplinary action causes and she will work with you to devise a clear plan to defend your license.  To discuss your circumstances in a free and confidential initial consultation, please call the Sanger Law Office at (785) 979-4353.