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.

Navigating the labeling requirements for over-the-counter (OTC) products can be difficult and confusing. This page provides a clear overview of what is needed to comply with regulations, including information on the types of ingredients that must be declared and how they should be displayed on labels. Our regulatory specialists will also help you with the eCTD requirements and submitting your application.

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.

NDC Numbers

Our regulatory consultants will help you sort out the details about NDCs, including what they mean, how to interpret them, and the regulations that come with using them.

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 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. 

OTC drug labelling

Warnings and Directions Labels

All over-the-counter (OTC) products must contain warnings and directions for use, both of which are dependent on the product’s active ingredients. Warnings required for OTC topical medications include skin irritation and hazards associated with the administered substance. Directions should outline how to properly administer the medication along with checklists of do’s and don’ts. It is important that consumers read these labels carefully before using any OTC product.

Ingredient Labeling Requirements

All OTC products must include a list of ingredients on their labels. This information helps consumers understand what substances are contained in the product and allows them to avoid ingredients they may be allergic to. Allergy information improves safety when using OTC products as individuals can identify any potential risks before applying the medication or ingesting it orally. Additionally, product formulation must also include proper dosing instructions for each individual ingredient used in the product.

OTC drug labelling
OTC drug labelling

Manufacturing, Storage, and Shipping Information

Information related to the manufacturer and storage of OTC products must be included in the product label. Depending on where a product is manufactured or stored, there may be additional responsibilities that manufacturers are required to adhere to. Additionally, if OTC products are shipped bulk-packed, shippers must adhere to specific regulations and follow state, local, and federal laws pertaining to all materials being shipped.

Regulatory Information on the Package or Label

Manufacturers of OTC products should include clear and accurate information that is relevant to the product on their labels or in the package. This may include expiration date, warnings, product specific directions, usage directions, entity responsible for testing the product and any other applicable regulatory information. All of this information should be clearly specified on the label or package to ensure that users are aware of all safety and usage instructions pertaining to the OTC product they are using.

OTC drug labelling
OTC drug labelling

Primary Display Panel Requirements

Primary display panel requirements for OTC products require that all ingredient names, consonant with good manufacturing standards, must be disclosed. This includes active ingredients as well as inactive or “other” ingredients, including colors and fragrances. Additionally, the required information from the panel must be in reverse type order, with the most prominent product name listed first followed by the active ingredients and dosage directions.

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.

Did you know?

Follow the Latest News, Blogs & Industry Updates

FDA Regulates Lab-Developed Tests for Safety

FDA (U.S) has recently revised its regulatory framework for laboratory-developed tests (LDTs). These in vitro diagnostic products (IVDs) are critical for analyzing substances such as

... Read more
Need OTC Drugs Compliance Assistance Today

Please complete the form below. We will respond to you soon.

Select all applicable Services
Select countries of interest
0/5 (0 Reviews)

Don't miss updates from Health Canada and FDA.

If you are looking for the latest regulatory updates or want the newest regulatory requirements guides, please leave your email and we'll keep you posted.

This website uses cookies to provide necessary site functionality and improve your online experience. By using this website, you agree to the use of cookies as outlined in Quality Smart Solutions's online privacy statement.