Seeking an OTC certified manufacturer? If you are looking to create your own acetaminophen or other non-prescription drug, we can help. These are called over-the-counter drugs, which you commonly see referred to as OTCs. We can help you build or expand your private-label product line with a variety of OTCs. With our multiple facilities across the country and our large supply chain, we are able to handle any scale of production project.
What Are Common OTCs?
When taken properly, OTCs help people recover from ailments or reduce pain. These are some examples of various actions of OTC substances:
- Sinus or eye irritation relief
- Headache relief
- Body ache or pain relief
- Fever reduction
- Allergy relief
- Itching relief
- Cough suppression
- Sore throat relief
According to the Food and Drug Administration, OTCs are generally safe to use without the supervision of a health professional. For this reason, they are sold on pharmacy shelves to anyone who wishes to buy them. Substances must follow the FDA drug monographs that apply to them. Although they are deemed to be mostly safe when taken as directed, misuse or overdose can be dangerous or fatal. It is important for sellers to prominently display such risks or side effects on the drug package or bottle.
Differences Between OTCs and Prescription Medications
These are the main differences between the two types of substances:
- Margin of safety
The margin of safety for an OTC is much wider than that of any prescription drug. Scientists measure safety margins using a complex set of calculations, historical data and more. To be compliant, an OTC drug must have every bit of necessary information on the label that a consumer may need to know. This is why you often see a lot of information on the box and on the bottle, and small bottles usually have a peel-back label to include additional information. OTCs have a drug facts label, which is also required by law.
When it comes to advertising of prescription medicines, the FDA oversees practices. The Federal Trade Commission, which is responsible for most other types of industries, has the authority to regulate advertisements for OTCs. Although prescription drugs are limited to about 55,000 pharmacies across the country, OTCs can be sold in nearly 750,000 pharmacy chains, retail chains, supermarkets and other stores.
Who Regulates OTCs?
The FDA is ultimately responsible for OTCs. However, it has multiple internal agencies. The FDA’s Center for Drug Evaluation and Research is the branch that handles OTC issues, and the specific office that deals with nonprescription drugs is the CDER’s Office of Nonprescription Drugs.
Although the chain of responsibility is primarily within the FDA, other agencies help with additional aspects. For example, packaging of OTCs is important, and the U.S. Consumer Product Safety Commission is the agency that handles child-resistant safety closures and similar packaging safety aspects. Actual inspections and application procedures are handled by certification bodies, which will be discussed in an upcoming section.
How the FDA Regulates OTCs
Unlike prescription medications, OTCs do not require individual licenses. There is a set of rules that any OTC manufacturer must follow. As long as the products meet the OTC monographs that are applicable, they can be marketed and sold. Monographs are regulatory standards for ingredients and labeling. These are some important points to remember about monographs:
- There are different monographs for various types of OTCs, such as antacids, pain relievers and others.
- The Code of Federal Regulations contains various monographs that manufacturers must use.
- If an OTC does not meet monograph outlines, it may require a new drug application.
How OTC Manufacturing Certification Works
Since individual licenses are not required for each drug, eligibility is a more standardized process. The certification process grants eligibility to produce general OTCs that meet monograph outlines.
Certification is not performed directly by the FDA. Instead, it has a chain of authority, which is structured like this:
- The FDA approves accreditation bodies.
- FDA-approved accreditation bodies approve certification bodies.
- Certification bodies audit manufacturers for compliance with FDA standards.
The American National Standards Institute is a common accreditation body that approves third-party certification bodies. For example, it accredited NSF and SGS as third-party certification bodies.
OTC Eligibility Process
These are the main steps in the certification process to manufacture OTCs:
- Self-assessment or third-party assessment.
- Application for certification.
- Audit scheduling and performance.
- Completion of audit report.
- Certification body management review.
- Rating for cGMPs designated.
- If applicable, corrective action plan is implemented.
- Certification decision is made, and certificate is granted if approved.
When ratings are assessed during audits, they are designated with a grade. These will be covered in the next section. If the auditor finds issues that can be fixed, those are listed in the corrective action plan. An additional monitoring audit may be completed to ensure compliance. It may be completed on the premises of the plant or online, and this often depends on the nature and severity of the problems. Once certification is granted, it is valid for a year.
If a certification body finds a non-conformance issue during a subsequent audit, it will be classified in one of the following categories:
- Critical non-conformance issues are serious failures or omissions, and they pose immediate safety risks.
- Major non-conformance issues are serious rule deviations and could pose safety risks.
- Minor non-conformance issues are slight deviations and do not pose immediate safety risks.
Each issue can be graded from A to D to indicate the severity of the problem. If the problem is not severe and can be remedied, a corrective action plan may be developed to help the company fix the problem immediately. Some major issues may warrant a stop in production to contain an issue or prevent a potential problem. With critical issues, processes are usually stopped until the problem is fixed. If a non-conformance issue is not fixed, the manufacturer can lose certification. During an audit, a certification body may also provide an observation, which is a suggestion for improvement.
If a manufacturer of a drug that does not fit existing monographs wants to market it, a new drug application must be submitted. The drug maker must provide the FDA with enough information to determine the following:
- If the drug is effective.
- If the drug is safe in its current form.
- If the benefits outweigh the potential risks.
- If the label’s information is accurate and adequate.
- If the manufacturing methods are adequate to preserve quality, strength, purity and integrity.
The FDA reviews the NDA, has specialists review the provided data and may call an advisory committee for recommendations. New data may be required after this, which could lengthen the process for potential approval. If the FDA decides that an application is complete and acceptable, it will grant the approval for marketing of the drug in the United States.
Why FDA OTC Certification Is Essential
Above all, compliance is essential to follow the laws. When you notify your potential customers that your product is manufactured in a compliant facility, these are some of the benefits:
- Help build trust and confidence in your brand.
- Show buyers that their safety is important to you.
- Give buyers reassurance that they are purchasing pure and potent products.
Why Work With Us?
If you are planning to sell OTC topical or edible supplements, we can manufacture them for you. Our large capacity and supply chain give us the ability to manufacture your current orders and larger orders as your brand grows in the future. These are some perks of working with us:
- We assign a dedicated account executive to you.
- We have a support team and excellent customer service.
- Our facilities offer research, development, formulation and flavoring assistance.
- Our product portfolio spans 95% of supplement forms and packaging options.
We have worked with Fortune 500 companies and all sizes of businesses. We also provide testing and safety information if you want it. Please contact us to discuss your OTC manufacturing needs.