Over-the-counter (OTC) drugs make up a large part of the drug market. You likely use OTC drugs every day – your toothpaste, antiperspirant, and headache medicine are all OTC drugs. Not only is this market large, but it is also easier to enter than the new drug and prescription drug market.
The two main kinds of OTC drugs: monograph drugs and homeopathic drugs. Neither requires a premarket Federal Drug Administration (FDA) approval, but both require intimate knowledge of the FDA drug system (labeling, registration, formulation, etc.).
Having an attorney with experience in all parts of the OTC drug system will enable you to navigate the FDA’s requirements while understanding, mitigating, and evaluating your regulatory risks.
In effect, the FDA has already approved the drug active ingredient and permitted claims, so any company making a product conforming to the formula and labeling requirements may enter the market.
Monograph drugs include various topical and ingested drugs like toothpaste, antiperspirants, sunscreens, cough medicines, headache medicines, and eye drops. Monograph drugs also include types of combination cosmetic drugs, such as face cream with SPF.
The keys to getting into this market include compliant formulation, labeling, facility registration, drug listing, and drug Good Manufacturing Practices (GMP).
Homeopathy is a form of medicine from the 1700s. It is based on the idea that consuming a tiny amount of an herbal substance that causes symptoms can cure the same symptoms. However, in common parlance, homeopathy is seen as just natural or herbal medicine.
The FDA takes no stand on the validity of this methodology and generally permits homeopathic products, provided they do not target vulnerable people or endanger public health by claiming to treat serious medical problems.
While the FDA takes an open approach to homeopathic products, the Federal Trade Commission (FTC) can be openly hostile. The FTC insists that labels and advertising of homeopathic products contain an “unscientific” disclaimer on all homeopathic claims unless you have significant premarket scientific evidence.
The market for homeopathic products is still wide open and homeopathic products can be marketed for treatments that dietary supplements cannot. However, homeopathic product manufacturers need to be careful to comply with FDA drug requirements and FTC marketing restrictions.
Hiring an experienced FDA attorney can help you thread the needle of FTC and FDA compliance to bring your traditional and/or innovative homeopathic product to market.
OTC –Over-the-counter, meaning that the drug can be purchased without a prescription from a doctor.
Monograph – An FDA-created regulation that outlines the formula and labeling required to market a particular drug without approval and without a prescription. See the FDA monographs here.
HPUS – The Homeopathic Pharmacopoeia of the United States, which is the official compendium of homeopathic drugs in the U.S. HPUS is issued by the Homeopathic Pharmacopoeia Convention of the United States (HPCUS), which is a non-government agency that advocates for and helps to systematize the industry.
Homeopathic Monograph – HPCUS-issued descriptions of homeopathic active ingredients. These monographs, unlike FDA-issued monographs, do not set forth the terms under which a drug may be legally marketed.
Drug Facility Registration – A registration for drug facilities. All drug manufacturers, repackers, relabelers, and salvagers are required to register each facility. This includes foreign facilities that offer drugs for import into the U.S. Additionally, foreign facilities need to identify each U.S. importer.
Drug Listing –Each drug that a drug facility manufactures, repacks, relabels, or salvages for commercial distribution. 21 C.F.R. § 207.41. Drug listings include label proofs and are public. See at Daily Med.
Drug Facts – The required panel on all OTC drugs that includes the drug concentration, indications for use, directions, counterindications, and storage requirements.
Homeopathic – As defined by the Homeopathic Pharmacopoeia Convention of the United States, homeopathy is “the art and the science of healing the sick by using substances capable of causing the same symptoms, syndromes, and conditions when administered to healthy people.”
We can help you prepare to enter the U.S. OTC drug market, including classification, formulation, registration, labeling, and importation. We also help you stay in the market through advocacy. We have years of experience representing our clients with the FDA, Customs, DEA, and other agencies.
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