Over-the-counter (OTC) drugs are defined by the FDA as drugs that are safe and effective for use by the general public without seeking treatment by a health professional. Currently, there are more than 300,000 OTC products on the market. Instead of reviewing each individual drug product, the FDA reviews the active ingredients and labeling of more than 80 classes of drugs.
Active ingredients are classified into three categories:
For each drug class, the FDA develops a monograph that is then published in the Federal Register. OTC drug monographs are essentially a recipe book of conditions for each therapeutic area that covers the acceptable ingredients, doses, formulations, labeling, and testing of OTC drugs.
OTC monographs specify the following:
The current OTC monograph rulemaking process requires the following three-step public notice and comment period be followed: (1) Advance Notice of Proposed Rulemaking (ANPR) followed by a period for public comment; (2)Issuance of a Tentative Final Monograph followed by a period for public comment; and (3) publishing of the final monograph in the Federal Register.
After it has been published, a final monograph may be amended, either on the FDA Commissioner’s own initiative or upon the petition of any interested person. OTC drug monographs are continually updated to add, change, or remove ingredients, labeling, or other pertinent information, as needed.
Once a final monograph is implemented, companies can make and market an OTC drug without the need for pre-approval from the Agency as long as the drug completely conforms to the monograph. If the drug doesn’t conform to the monograph, it must be reviewed by the FDA using the new drug application (NDA) process.
Products introduced to the market under an OTC monograph are bound to the same standards of safety and efficacy as an NDA-approved drug, and compliance with GMPs is still required. However, unlike products marketed under an approved NDA, OTC products are only required to report serious adverse events.
FDA has developed format and content requirements that manufacturers must follow when labeling their OTC drugs. The standardized format is called the “Drug Facts,” and the content requirements are outlined in 21 CFR 201.66.
The regulation of sunscreen products provides an excellent look at the monograph process. The FDA issued a proposed rule on February 26, 2019 to put into effect a final monograph for nonprescription, OTC sunscreen products. The proposed rule describes the conditions under which the FDA proposes that OTC sunscreen monograph products are GRAS and effective and not misbranded. Final comments on the proposed rule were due on May 28, 2019.
The reasoning behind the proposed rule is that the FDA is considering certain active ingredient safety issues further. As such, in forthcoming rulemaking, the FDA intends to request additional data regarding the safety of the individual sunscreen active ingredients in light of changing conditions, including substantially increased sunscreen usage and exposure and evolving information about the potential risks associated with these products since they were initially evaluated. This further review will have the impact of updating the original sunscreen final rule that was published in 1999.
The proposed rule is in line with the FDA’s current understanding regarding the evaluation of safety of topical drug products for chronic use, including topical safety studies (irritation, sensitization, and photosafety), and bioavailability (absorption). Given the long history of marketing the active ingredients in sunscreen products, unlike the nonclinical data required to meet the standard for approval of chronic-use topical NDA products, the approach to nonclinical safety testing is largely focused on potential long-term adverse events or effects not otherwise readily detected from human use (i.e., carcinogenicity and reproductive toxicity).
Proposed safe and effective categorizations were as follows:
Proposed requirements related to dosage forms were as follows:
Proposed maximum sun protection factor and broad spectrum requirements were as follows:
It’s clear that the regulation of sunscreen products is going through a substantial overhaul. However, when the final monograph is published, drug makers in the sunscreen industry will have a clear mandate regarding whether and how they can market their products.
Do you manufacture a sunscreen or other OTC product? We can help ensure that you are in compliance with all of FDA’s monograph requirements. To learn more about our OTC services, contact us and how we can help you, today.
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