Today, nonprescription drugs, also referred to as Over-the-Counter Medication, are an important health resource. These products represent a tightly regulated industry, subject to FDA scrutiny and oversight. If you are looking for counsel to assist you on matters involving Nonprescription drugs, welcome to Fuerst Ittleman. Associates at Fuerst Ittleman bring a wealth of experience and knowledge on nonprescription drug regulation. We assist clients by performing label reviews to ensure full compliance with FDA regulations. We counsel on current Good Manufacturing Practices (cGMPS) and proper operating requirements. We evaluate drug advertisements and promotional materials for FDA and if applicable, FTC compliance. We serve as attorneys at law for matters involving FDA action and other disputes.
Our lawyers understand the complex regulatory framework involving Nonprescription drugs and how it differs from Dietary Supplements, Homeopathic Drugs, Medical Foods, and Prescription Drugs. If you are launching a new product and looking for the correct regulatory scheme, let Fuerst Ittleman guide you. Whether it’s filing an NDA, navigating the monograph system of approval or seeking an Rx to OTC switch, Fuerst Ittleman can provide a judicious and efficient path to protection. Let Fuerst Ittleman guide you on drugs that are GRASE (Generally Recognized as Safe and Effective). Fuerst Ittleman can also assist with Time and Extent Applications (TEA) for amendments to an OTC monograph. Furthermore, Fuerst Ittleman attorneys understand the post-approval requirements for Nonprescription Drugs including adverse event reporting and the ancillary regulations involved such as wholesaling, drug recalls, tamper-evident requirements, and National Drug Code (NDC) directory matters.
For more information for how we can assist with your OTC/Non-Prescription Drug Product, please contact us at contact@fuerstlaw.com or (305) 350-5690.
