Get Brochure

An Over-the-Counter (OTC) product refers to medicines and health-related items available for purchase without a prescription from a healthcare professional. Unlike prescription medications, which require a doctor's authorization due to their potent ingredients or potential side effects, OTC products are deemed safe and effective for use by the general public without needing professional supervision. These products encompass a wide range of categories, including pain relievers, cough and cold remedies, anti-allergy pills, vitamins, skin treatments, and even some types of contraceptives.

What are some of the regulatory considerations for OTC products?

OTC products must contain active ingredients that are recognized as safe and effective for their intended use. Companies must conduct thorough research and provide data to regulatory authorities demonstrating the safety, efficacy, and appropriate dosage of these ingredients. Formulation considerations include ensuring stability, compatibility, and proper manufacturing processes. OTC product labels must provide clear and accurate information to consumers, including indications for use, dosage instructions, warnings, precautions, and possible side effects. Labeling must comply with regulatory guidelines, such as the FDA's Over-the-Counter Drug Facts Labeling Requirements in the United States, to ensure consumer understanding and safety. Packaging design should also be user-friendly and tamper-evident.

OTC products must meet stringent quality and manufacturing standards to ensure consistency, purity, and potency. Companies must adhere to Good Manufacturing Practices (GMP) and quality control measures throughout the manufacturing process to produce safe and effective products. Companies are required to conduct clinical studies, safety assessments, and efficacy trials to generate data supporting the safety and effectiveness of their OTC products. This data is submitted to regulatory authorities for review and approval before marketing the products to consumers. OTC products must comply with regulatory requirements and guidelines set forth by national regulatory affairs agencies, such as the Food and Drug Administration (FDA) in the United States or the European Medicines Agency (EMA) in Europe. Companies must submit comprehensive applications, including data on active ingredients, formulation, labeling, manufacturing processes, safety, and efficacy, for regulatory review and approval.

After approval, companies must continue to monitor the safety and performance of their OTC products through post-market surveillance and adverse event reporting. They are required to promptly investigate and report any adverse events or product quality issues to regulatory authorities.


Key aspects for OTC products must be taken into consideration as they ensure that the product is safe, efficacious, and of high quality so that consumers can use them without the need for a prescription. These considerations encompass various aspects that OTC manufacturers must address in order to obtain regulatory approval and market their products successfully and compliantly.

How can we help you?
Call us on:+1 (302) 601-2755
Contact our experts today !
bio InternationalDia Global