OTC Manufacturing with UPM Pharmaceuticals

With over 300,000 OTC drug products in existence on the market, the Food and Drug Administration (FDA) is in charge of reviewing active ingredients and labeling over 80 therapeutic classes of drugs. To legally launch an OTC drug, it must comply with the OTC drug monograph to which it is assigned. Monographs note acceptable ingredients, doses, formulations and labeling and help streamline the introduction of well-studied drug products to the market.

Once a final monograph is developed and published, an OTC manufacturing company can take the following steps to create and market its product without pre-approval from the FDA:

• Product conceptualization — This stage includes selecting active ingredient(s) and their potencies, as well as ensuring the ingredients comply with an applicable OTC drug monograph.
• Formula development — Experimental batches and a significant amount of lab testing typically occur during this stage
• Selecting the container or closure system — Any plastic container system must be tested for the presence of undesirable elements that could mix with the drug products during packaging.
• Development specifications — Formal specifications must be established for raw materials, container components and finished drug products.
• Validation of testing methodologies — This step helps ensure the accuracy and suitability of testing methods.
• Determining the product's expiration date — A "stability batch" is created and tested to establish an appropriate expiration date to be used when the product launches.
• Product label creation — It's important to carefully review labeling artwork for accuracy and OTC drug monograph compliance
• Process validation — This stage helps ensure the process equipment and operating parameters are appropriate and helps create a product that meets all specifications and acceptance criteria.
• Drug listing — Owners of OTC drug products must complete and submit a Drug Listing Form to the FDA regarding the product they intend to launch.