Consumers can purchase them directly without a prescription from a licensed healthcare professional. Regulatory agencies like the FDA have determined that OTC drug products can be safe and effective for use by consumers when the products are used as directed according to the label instructions but may impose additional requirements or limitations on use.
Is this lip balm an OTC drug or is it a cosmetic? What makes it an OTC a drug and not just a regular product? First, we need to start with the definitions. A drug is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease or to affect the structure or any function of the human body. A cosmetic is a product intended to be applied to the human body for cleansing, beautifying, and promoting attractiveness, or altering the appearance without affecting the body’s structure or function. To illustrate the difference: a standard shampoo without any medical claims is meant to only clean and cleanse the hair and scalp; this is a cosmetic. A shampoo that cleanses the hair, but also has a specific therapeutic claim and active ingredient intended to treat dandruff is categorized as an OTC drug. Other products produced by cosmetic manufacturers that are considered OTC products include anti-acne, antifungal, antimicrobial, antiperspirant, anti-dandruff, external analgesic, sunscreen, skin protectants, and even toothpastes that contain fluoride. It’s important to know the difference so you are following the correct regulatory guidelines for your products.
There are additional layers to identifying an OTC. OTCs may have the same active ingredients found in prescription drug products; however, they will be at a lower concentration that is within a safe and effective range for consumer use without a prescription. OTC products need to both have a therapeutic claim that demonstrates the product serves a medicinal purpose and have an active ingredient within a percentage range allowed for OTC drug products. For example, a formula that contains an OTC active ingredient below the concentration threshold of OTC status could change its classification from an OTC to a cosmetic according to the FDA because, depending on the nature of the ingredient, it could no longer fit the definition as a treatment for a medical condition. All conditions must be met to be legally marketed as an OTC.
OTCs are regulated differently
OTCs are more strictly regulated than cosmetics so manufacturers will need to adhere to different quality guidelines in production and testing. OTC drug products may also be subject to specific regulations depending on their intended uses. For example, in order to make broad spectrum, skin cancer prevention, or water resistance claims, OTC sunscreens must be tested according to rigorous FDA testing protocols. Some countries have additional requirements for OTC drug products. Japan requires that all OTC drug products be registered with the government before they can be sold. It’s up the manufacturer to know the requirements for OTC products in the countries where they are manufactured and sold.
There are two regulatory pathways to bring a non-prescription OTC drug product to the US market. The two ways to market are the new drug application (NDA) process or OTC drug monograph process. The NDA process is generally considered to be expensive and time consuming, so many companies opt to formulate and market OTC drugs under the OTC drug monograph process. The OTC monograph system is a series of established guidelines for formulation and testing of many OTC drug product categories, established in 1972, the “OTC Drug Review”. The OTC monograph is like a “rule book” or “recipe book” on how to create an OTC, establishing which active ingredients would be considered generally recognized as safe and effective (GRASE) for certain intended uses. The OTC Drug Review was a complex and slow-moving series of proposed and final monographs published by the FDA, with monographs remaining unfinalized for literally decades. The CARES Act of March 2020 revamped the system, allowing the FDA to finalize most monographs through a series of orders. As of Nov 2023, there are currently 32 finalized OTC drug monographs, including those for acne, sunscreen, and skin protectant products. If you follow the monograph, then you can release your product to the market without doing an NDA. It includes active ingredients, appropriate usage, dosage, administration, labeling, and testing for the specific therapeutic category. These standards established GRASE. Each monograph has detailed information regarding the active ingredients with specific GRASE concentration ranges and allowable limits. OTC monographs are also living documents that change and update over time. The FDA has the authority to change the conditions of an OTC monograph so someone within your company should be responsible for monitoring updates for these standards. In addition, for a fee, an industry can request changes to these monographs, such as adding additional active ingredients or intended uses, if properly substantiated as GRASE.
Reduce your risks with GMP
More and more personal care products are being classified as OTC drug products bringing increased regulatory oversight and requiring companies to adopt Good Manufacturing Practices (GMP) and pharmaceutical level quality control standards. GMP provides guidelines for quality manufacturing of products through standardized procedures and regular oversight of facilities, records, staff, industrial hygiene, and overall operations.
GMP focuses on record keeping and standard operating procedures and gives you more control of your facility’s environment. GMP is all about putting quality assurances throughout all aspects of the manufacturing process. This comes down to not only following these quality procedures but also effectively documenting them and recording training. GMPs define responsibilities, processes, and procedures as well as implementing controls to reduce risk to industrial hygiene. All areas of manufacturing require quality procedures to follow GMP, these can include facility construction, raw material specifications, labeling, equipment, distribution, and overall records retention. Having SOPs for OTC documentation can help improve your company’s efficiency and reduce human error. There are many established certification companies that offer SOP templates to help meet quality and safety standards.
Cleaning matters, too, and it must be documented. Cleaning is a significant cause for quality concern because if a facility does not follow proper cleaning procedures, there can be significant contamination risks. It is not just your facility, it is important to note if you are working with a contract manufacturer, you must confirm that the third-party facility is following the same required OTC GMP guidelines and continue to inspect their facility with reoccurring audits. The burden of quality is on the brand owner and not the FDA. Contract manufacturing labs can be FDA registered but there are no FDA “approved” labs. That means companies need to be sure that their contract labs are following GMP guidelines and request documentation on their processes such as cleaning procedures, equipment, training, etc. to ensure the chain of quality.
Higher quality processes with rapid microbial detection methods OTC products have different regulatory requirements from cosmetics including increased testing and method validation, and additional documentation required for workflows, procedures, and training. Currently many labs are still using traditional microbial detection plating methods. Rapid microbial detection methods can be the solution to easier documentation, reduced human error, and overall
enhanced quality. Manual and subjective processes like traditional plating methods can be difficult to train adequately, increases the potential for human error, and are cumbersome to document. Automated processes like rapid microbial detection methods require significantly less training to operate. Rapid methods already have documented processes and vendor-supplied protocols. Rapid methods produce objective results, easy to document, and result in higher data integrity. When exploring rapid method options, find a vendor that can aid in the training process to help prevent training inconsistencies from happening in your workplace. For more information on rapid microbial detection methods for OTCs, www.criver.com
It is critical for personal care product manufacturers to understand which of their products fall under OTC drug product regulations. Additional regulatory oversight for OTCs requires companies to adopt GMP and maintain quality control standards. Whether it is developing SOPs, understanding the GMP requirements, or exploring a rapid microbial technology, improving quality manufacturing is essential to keeping your products safe for consumers to use. The quality of your product is important to the reputation of your brand, and therefore, the trust that consumers have in your company. Don’t be caught with a compliance issue during an audit and find out you are not following the appropriate guidelines for OTC products. This article was written in partnership with Anna Benevente, Director of Product, Labeling, and Ingredient Review at Registrar Corp.