A new law has been passed in Florida that pertains to prescribing and dispensing controlled substances. On March 19, 2018 Governor Scott signed HB21, which becomes effective July 1, 2018. Intended to address the growing nationwide opioid epidemic that has also greatly affected Floridians, among other requirements, the new regulations establish: read more
By: Matthew Fischer
Through two public channels this month, the FDA further solidified its stance on the innovative field of regenerative medicine. First, in an article published in the New England Journal of Medicine (NEJM), Dr. Scott Gottlieb, FDA Commissioner, and Dr. Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research (CBER), co-wrote a new paper entitled “Balancing Safety and Innovation for Cell-Based Regenerative Medicine.” On the same day of this publication, the FDA hosted a “Grand Rounds” webcast with Dr. Steven Bauer, Chief of the Cellular and Tissues Therapy Branch within CBER. Taken together, these actions suggest a continued effort by the FDA to take a strong position against predatory clinics touting unapproved therapies while extending an open invitation to industry developers for expedited treatment to encourage innovation. read more
By: Matt Fischer
The Drug Enforcement Administration (DEA) is responsible for the monitoring of all manufacturing and distribution of controlled substances in the country. Pharmacies, medical providers (i.e., who either administer, prescribe or dispense), and distributors and manufacturers of controlled substances are required to register with the DEA. The DEA’s Diversion Control Division is tasked with reviewing applications of potential registrants and monitoring existing registrants through audits and investigations. However, the question on many registrants’ minds is what happens if violations or deficiencies are discovered? The answer is it depends. The consequences will vary based on the level of noncompliance. Thus, it is essential to be familiar with the laws that apply and most importantly, have a full understanding of the administrative process in order to act quickly to minimize potential adverse action if noncompliance is found. read more
By: Matt Fischer
The Drug Enforcement Administration (DEA) is responsible for monitoring the supply and distribution of all controlled substances. All medical providers, pharmacies, manufacturers of pharmaceuticals, and distributors of pharmaceuticals must be registered with the DEA. DEA registrants are governed by an ever-growing web of federal laws and regulations which if violated may result in revocation of registration, fines, and/or criminal prosecution. Therefore, it is important when starting a business or purchasing an existing business requiring DEA registration to be proactive and prepared for periodic administrative inspections or audits.
The Diversion Control Unit is tasked with monitoring compliance and empowered to conduct inspections by the Controlled Substances Act (CSA). Under the CSA, diversion investigators have the authority to (1) inspect, copy, and verify records required to be kept (e.g., prescription and inventory records); (2) inspect equipment; (3) make a physical inventory of controlled substances; (4) collect samples of controlled substances; and/or (5) inspect any other records appropriate for verification under the CSA. However, there are limits to what can be inspected (unless an owner or agent of the owner consents). Inspections do not extend to financial data, sales data (other than shipping data), or pricing data. read more