OTC FDA Drug Compliance Solutions

Get comprehensive solutions for Drug Facility Registration, NDC Registration, Drug Facility Renewal, Drug Label Compliance, Drug Facts Panel, and Drug Development Cycle such as business planning, product development, and preparing compliant draft labels.  Our US compliance experts can help you get an NDC number and sell your OTC drug products in the USA.

OTC Drugs in the USA

Drug categories include Over-the-Counter (OTC), prescription medications, radiopharmaceuticals, biologics, and gene therapies. OTC medications, often known as non-prescription pharmaceuticals, are health products offered in the United States that may be purchased without a medical prescription. These medications are both safe and effective in limited quantities and can be sold freely on store shelves. 

In the United States, the FDA performs a regulatory evaluation of over-the-counter pharmaceuticals based on active pharmaceutical ingredients and labeling rather than evaluating specific drug formulations. In the United States, there are about 300,000 OTC medications on the market. 

Wondering how to get an NDC Number?

OTC drugs sold in the United States must be labeled with a National Drug Code (NDC). This number on a product label shows that the medicine has satisfied all quality, safety, and efficacy standards. Any firm wanting to manufacture OTCs in the United States must guarantee that their product fulfills the criteria for safety and efficacy. They should check to see whether they are in compliance with GMPs and fulfills the labeling criteria outlined in 21 CFR part 201.66. In many circumstances, satisfying FDA standards can be a complicated task. Quality Smart Solutions can assist you in precisely and effectively preparing your OTC product registration and obtaining an NDC number for your product.

Regulatory Pathways

OTC Drug Monograph Application and the OTC New Drug Application (NDA) are the two processes through which every OTC Drug manufacturer or packager has to market drugs in the US market.

Good Manufacturing Practices

Whether you’re a domestic or foreign manufacturer or importer of OTC Drugs, you need to show evidence that you meet GMP requirements.

Drug Facility Registration

We'll prepare your application for establishment registration on behalf of your firm and submit it to FDA through the applicable ESG gateway.

OTC Drug Compliance Solutions in the USA

At Quality Smart Solutions, we have the capability to offer assistance in all phases of the drug development and marketing process, including product development, facility registration, business planning, USA drug label compliance, and more.

National Drug Code (NDC) Labeler Code Registration

Get solutions for NDC Labeler Code by preparing and making a submission request in Structured Product Labeling (SPL) format via FDA's ESG (Electronic Submission Gateway).

US Drug Listing (DRLS)

Our OTC Drugs specialists help register OTC drugs and submit important listing information on time for all drugs in commercial sales and distribution.

US Drug Label Compliance

We’ll review pre-approval label or label development and guide you on labeling modification to ensure compliance with US Drug Label requirements.

Drug Facility Registration and Renewal

We’ll prepare your application for establishment registration SPL on behalf of your firm and submit it to FDA through ESG gateway. We also help in the renewal process.

US Agent Service

Partner with a certified US Agent for non-US firms. We’ll respond to FDA questions, help during meetings with officials, receive all essential documents, and provide them to you.

Frequently Asked Questions

OTC stands for “Over-The-Counter”. Non-prescription drugs, also called over-the-counter drugs, are health products that can be bought without a doctor’s prescription.

Domestic and foreign establishments that manufacture, repack, or re-label drug products in the United States are required to register with the FDA. Domestic and foreign drug manufacturers, repackers or re-labelers are also required to list all of their commercially marketed drug products. 

Domestic and foreign establishments that manufacture, repack, or re-label drug products in the United States are required to register with the FDA. Domestic and foreign drug manufacturers, repackers or re-labelers are also required to list all of their commercially marketed drug products. FDA regulations work to make sure that OTC drugs are safe and that the labels are easy for consumers to understand.  All OTC drugs must meet FDA quality, safety and effectiveness standards.  To learn more about these standards message us at info@qualitysmartsolutions.com 

To register or list your OTC drugs products, you’ll need to complete an establishment registration and file the appropriate drug listing information through the FDA’s online portal. If you need help with importing OTC drugs products you can email us for more information at info@qualitysmartsolutions.com. 

OTC drugs that are sold in the U.S need to be labelled with a National Drug Code (NDC) which shows that the medicine has satisfied all safety, quality and efficacy standards.  There are regulatory pathway requirements that include two processes every OTC drug manufacturer and packager must follow in the US market.  These include the OTC Drug Monograph Application and the OTC New Drug Application (NDA).  You’ll be required to show evidence that you meet GMP requirements as well if you are an importer of OTC drugs.  You’ll also be required to obtain an Establishment Licence for manufacturing, selling or importing non-prescription drugs in the U.S.

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