FDA Regulatory Requirements Continue to Swell

The tide of federal healthcare regulations continues to rise. Healthcare providers need to stay informed. A recent study by George Mason University found that between 2000 and 2012, the number of regulatory requirements imposed by the United States Food and Drug Administration (the “FDA”)—the agency responsible for developing and administering regulations pertaining to pharmaceuticals and medical devices— increased by fifteen (15%) percent. Quantified, the increase represents approximately 2,448 new regulations, with an average of seventeen (17) new regulations per month. This figure does not account for the various States’ Regulations developed in response to new or altered Federal Regulations. Pharmacies that are out of state licensees in many states must be familiar with the various state laws as well.

As Federal Regulations continue to increase in number, so does the actual text of the law. The FDA portion of the Code of Federal Regulations (the Code) increased by a total of 166,892 words between 2000 and 2012. The Code provides specific legal definitions for many of these new words which may differ from the vernacular used in the healthcare industry. Additionally, the specific legal definition for any given word is subject to change at any given time. Pharmacies and healthcare providers are tasked with knowing these mercurial definitions to ensure that they are compliant with the law.

As a law firm that focuses on services to pharmacies and other healthcare providers, Frier Levitt can help assess your practices and standard operating procedures to ensure they are in full compliance with the ever-changing, regulatory landscape. We are familiar with the Federal Regulations affecting the health care industry and understand the challenges you may be currently facing as a provider. Contact us today to speak to one of our attorneys.