Representing clients in matters of Florida and federal laws and regulations. Licensed to practice law in Florida, only.
Retailers, manufactures and retailer/manufacturers of tobacco products should take note that compliance with the U.S. Food and Drug Administration (FDA) new tobacco rules is rapidly approaching. Certain provisions of the final rule become effective Monday, August 8, 2016. On May 10, 2016, the FDA issued its final rule expanding the FDA’s definition of “tobacco
Read MoreOn 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Read MoreOn May 12, 2016 the U.S. Food and Drug Administration (FDA) published a draft guidance titled “Use of Electronic Health Record Data in Clinical Investigation,” which is intended to guide clinical trial sponsors, investigators, contract research organizations (CRO), and institutional review boards (IRB) on the use of electronic health record (EHR) data in FDA-regulated clinical
Read MoreOn May 10, the U.S. Food and Drug Administration (FDA) issued draft guidance titled “Technical Considerations for Additive Manufactured Devices” providing its initial thoughts on regulatory requirements for additive manufactured (AM) devices (aka 3D printed medical devices), the category of manufacturing that includes 3-dimensional (3D) printing. The FDA described this as a “leapfrog” guidance through
Read MoreThe Food and Drug Administration (FDA) recently issued a final guidance declaring use of the term “evaporated cane juice” (ECJ) on food labeling to be misleading. “Evaporated cane juice” is a term commonly used on food labels to identify the presence of sweeteners derived from the fluid extract of sugar cane. However, FDA’s most recent
Read MoreThe U.S. Food and Drug Administration (FDA) issued a constituent update today explaining its decision to allow KIND, LLC to use “healthy” claims on food labels and labelling, while also vowing to reevaluate regulations regarding nutrient content claims and the labeling of food as “healthy.” Nutrient content claims are those that expressly or implicitly characterizes
Read MoreThe Food and Drug Administration (FDA) today announced long-awaited final rules expanding the FDA’s authority over e-cigarettes and other tobacco products. The rule broadens the definition of tobacco products to include e-cigarettes, hookahs, pipe tobacco, premium cigars, little cigars and other products. Acting under its authority as established through the Tobacco Control Act of 2009, the FDA has
Read MorePhoenix Cardiac Surgery, P.C., of Phoenix and Prescott, Arizona, has agreed to pay the U.S. Department of Health and Human Services (HHS) a $100,000 settlement and take corrective action to implement policies and procedures to safeguard the protected health information of its patients. The settlement with the physician practice follows an extensive investigation by the HHS Office for Civil Rights (OCR) for potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy and Security Rules. For assistance developing a HIPAA compliance program or responding to a HIPAA breach, contact Rafael A. Gaitan, Esq. Mr. Gaitan has over 15 years experience in the health care industry and regularly counsels physician practices on regulatory matters including HIPAA and the HITECH rules.
Read MoreSection 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 MoreOn March 5, 2012, The U.S. Food and Drug Administration (FDA) issued a warning letter to Breathable Foods Inc., makers of AeroShot1, for false or misleading statements in the labeling of their product, and told the company that the Agency has questions about the safety of the “caffeine inhaler.” The FDA also expressed concern about the
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