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FDA: Drug Regulation

While drug regulation can be burdensome for market entrants, our attorneys are able to guide companies of all sizes through the regulatory maze. A drug is “any article intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease” and “articles intended to affect the structure or function of the body.” (FDCA 201(g)). The U.S. Food and Drug Administration (FDA) drug regulatory regime extends to over-the-counters (OTCs), non-prescription, prescription, homeopathic, and active pharmaceutical ingredients (APIs). It can also inadvertently extend to an article when its intended use is established by label and labeling claims. This then renders an article an unapproved new drug. Complicating matters involve those articles that are regulated as both cosmetics and drugs (either by intended use claims or statutory obligations). For example, antiperspirant/deodorant, anti-microbial soap, and SPF products, must meet the regulatory requirements of both cosmetics and drugs. All drugs – regardless of class – must be safe and effective for their intended use.

Regulatory requirements differ based on the type of drug you’re attempting to bring to market – whether it be those requirements outlined in a monograph for OTCs, monographs in the Homeopathic Pharmacopeia of the United States (HPUS) for homeopathics, or the various requirements for importing an API into the United States for purposes of use in an approved new drug application (NDA), abbreviated new drug application (ANDA), pharmacy compounding, prescription drugs, OTCs, or use in teaching, law enforcement, or research and analysis.

Regardless of the drug you manufacture, distribute or import, the FDA spends significant resources making sure all actors in the supply chain adhere to FDA regulations as it relates to registration/listing requirements, current Good Manufacturing Practices (cGMPs), drug label and labeling requirements, and various reporting requirements to the agency. Regardless of the size of your team or FDA experience, we can guide you through the extensive drug regulatory requirements, which include:

  • Regulatory guidance for OTC drug manufacturers, distributors, internet marketers and importers/exporters
  • Drug label and labeling reviews, advertisements, Internet marketing and social media network analysis
  • Registration/Listing services for all drug manufacturers, processors, packers, repackers, labelers, and relabelers who offer drugs for sale in the United States
  • Representation against unapproved new drug charges by the FDA
  • Monitoring and developing intended use claims
  • Adhering to all drug Current Good Manufacturing Practices (cGMPs) requirements
  • U.S. Agent duties
  • Import/export assistance for all drug products, including APIs
  • Homeopathic Compliance Policy Guidance assistance and ingredient reviews
  • Audits of your operations and risk assessment related to non-compliance
  • Development of Standard Operating Procedures (SOPs) for complex supply chains
  • Defense against FDA and FTC enforcement actions such as product recalls, FDA detentions and refusals, warning letters, 483s, adulteration and misbranding charges, import alerts, or claims brought by state and federal prosecutors for violation of safety regulations, and for false labeling and advertising
  • U.S. Customs matters such as Form 28s, liquidated damages, criminal investigations, seizures, HTS classifications, free trade agreements, country of origin issues, and import/export guidance
  • Analysis and advocacy with respect to relevant legislation and regulatory matters
  • Obtaining patents and trademarks, and gray market protection strategies