On February 29, 2016, the FDA published a guidance entitled “Requirements for Transactions with First Responders under Section 582 of the Federal Food, Drug, and Cosmetic Act—Compliance Policy.” The guidance is effective immediately (starting on Tuesday, March 1) and states that the Agency will not take action against first responders failing to obtain product tracing information, as required under
Section 465.018, Florida Statutes was amended in 2011, by HB 7095 to require every community pharmacy that dispenses Schedule II and Schedule III controlled substances to be re-permitted by July 1, 2012. All owners, officers, and prescription department managers of the community pharmacy will need to submit fingerprints to the Department of Health as part of the permitting process; and the community pharmacy must implement written policies and procedures for preventing controlled substance dispensing based upon fraudulent representations or invalid practitioner-patient relationships. To avoid disruptions to a business, community pharmacies are advised to begin the permitting process immediately. For assistance and guidance with applying for a community pharmacy permit, developing policies and procedures for preventing controlled substance dispensing fraud and abuse, or to appeal a permit denial or revocation, contact Rafael A. Gaitan, Esq. Mr. Gaitan has over 15 years experience in the health care industry, regularly representing pharmacies and pharmacist before regulatory bodies like the Florida Department of Health, and the Board of Medicine. Mr. Gaitan can be reached via e-mail at [email protected] or via telephone at 305.329.1462.