FDA OTC Monograph

Drugs | OTC/Homeopathic

Over-the-counter (OTC) drugs are medicines that may be sold directly to a consumer without a prescription from a doctor, as compared to prescription drugs, which may only be sold to consumers possessing a valid prescription. It is important to note that in the United States, OTC drugs are usually regulated based upon their active pharmaceutical ingredients (APIs), not necessarily by final formulation. By regulating APIs instead of specific finished drug formulations, FDA allows manufacturers freedom to formulate ingredients, or combinations of ingredients, into proprietary mixtures within the scope of broad regulatory requirements.

Get Started Today.

FDA has published OTC monograph regulations for a number of OTC drug categories. These OTC monographs state the specific requirements for categories of non-prescription drugs, such as what active drug ingredients may be used and for what intended uses. Most OTC drugs may be marketed in the U.S. without specific FDA approval. However, once a regulation covering a specific class of OTC drugs is final, those drugs must either 1) be the subject of an approved New Drug Application (NDA), or 2) comply with the appropriate OTC monograph regulation. OTC drugs are classified and generally recognized as safe and effective (GRASE) for use.

However, like all drugs, OTC drug labels must be correct according to FDA regulations. Many of the drug labeling requirements are general for all drugs and do not appear in the FDAs OTC monograph regulations. Therefore, it is important to evaluate your OTC drug using all of the relevant FDA regulations rather than the OTC monograph only.

FDAImports.com, LLC has many foreign and domestic clients who are OTC drug manufacturers, distributors, Internet marketing companies and drug importers. FDAImports.com, LLC finds The Way Through for its drug company clients and assists companies with the drug importation documentation and clearance process. This is particularly important when FDA detains an imported drug shipment. FDAImports.com, LLC understands the FDA OTC drug labeling requirements, the OTC monograph system, and the FDA and Customs drug import procedures and is able to help reduce the risk that your imported drug shipments are detained or delayed by FDA or Customs.

Homeopathic Drugs

The FDCA and FDA regulations govern homeopathic products as homeopathic drugs. Homeopathic drugs may be either prescription or OTC drugs. Homeopathic drugs are generally subject to the same FDA regulatory requirements as other drugs. Nothing in the FDCA expressly exempts homeopathic drugs from any of the FDCA or FDA drug regulation requirements related to drug adulteration, drug labeling, drug misbranding, or even FDA approval. However, the FDCA expressly recognizes the Homeopathic Pharmacopeia of the United States (HPUS) as a legal standard and authority for establishing drug quality and drug compliance. The HPUS, in turn, includes methods of homeopathic drug manufacture (or attenuation), homeopathic drug labeling requirements, and homeopathic drug monographs that all homeopathic drugs must comply with.

Because of this apparent conflict between the HPUS and the FDA regulations, FDA issued a homeopathic drug Compliance Policy Guide (CPG) that identifies specific conditions under which homeopathic drugs may ordinarily be marketed without a new drug application approval. For a homeopathic drug product to fall under the enforcement policies set forth in the CPG, it must meet the conditions set forth in the CPG.

FDAImports.com, LLC regularly assists homeopathic drug manufacturers, distributors and importers in complying with the HPUS, the FDA drug labeling regulations, and the FDA Homeopathic Drug CPG. Homeopathic drugs may be OTC drugs or prescription drugs depending upon whether they are intended for use in self-limiting disease conditions amenable to self-diagnosis.

Homeopathic drug dosages are based on principles of serial dilution (attenuation) and homeopathic products are labeled and marketed in strengths that indicate the number of dilutions that the substance has undergone in the manufacturing process. However, all homeopathic drugs must also comply with other FDA drug labeling regulations. Where an HPUS requirement conflicts with FDA regulation and no explicit FDA regulatory exemption exists, the FDA regulation controls.

Balancing the requirements of the HPUS and the FDA regulations for homeopathic drugs can be confusing. However, if a product is a homeopathic drug, is subject to valid homeopathic proving (of efficacy as a homeopathic product), is compliant with all drug labeling requirements, is from an FDA registered drug establishment, and is listed as required by FDA regulations, it can be marketed in the U.S. without FDA approval. This is a significant benefit for marketing homeopathic drugs in the U.S. and increasingly, foreign homeopathic drug manufacturers are successfully exporting homeopathic drugs to the U.S.

FDAImports.com, LLC can help you determine whether your drug product (or even your dietary supplement or cosmetic product) might be lawfully marketed in the U.S. as a homeopathic drug. The benefits include making lawful drug claims on the drug label (claims that relate to treating, curing, mitigating or preventing disease or otherwise affecting the structure or functions of the human body). With the current emphasis on natural products and organic products, the homeopathic drug industry is growing dramatically in the U.S. However, failing to comply with the HPUS, the FDA regulations and the FDA CPG can cause your article to be regulated as an unapproved drug, a misbranded drug or an adulterated drug. This can result in FDA import detention, FDA Import Alerts, and FDA import refusal of admission. FDAImports.com, LLC can show your company The Way Through these regulatory and HPUS requirements to successfully import and market a homeopathic drug in the U.S.

Need Help?

At FDAImports.com, LLC we make certain our importing clients understand the importation process and assist our clients in identifying appropriate actions and responses should Customs demand redelivery of a conditionally released product, or should that agency issue a demand for payment of liquidated damages pursuant to the importation bond. It is important for your company to know and follow the laws, regulations, and procedures when importing products into the United States. Get Started.