Category Archives: Pharmacy Regulation

22 Jun

FDA Targets Online Sales of Illegal Prescription Drugs

On June 9, 2016, The U.S. Food and Drug Administration (FDA) announced that it took action against 4,402 websites illegally selling unapproved prescription drugs to U.S. consumers. With the assistance of U.S. Customs and Border Protection, the FDA conducted inspections at International Mail Facilities (IMFs) and served formal complaints on domain registrars “requesting the suspension

Read More
17 Apr

Community Pharmacy Re-permitting Required Before July 1, 2012

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.

Read More