A scientist working in a licensed drug manufacturer's lab.
ComplianceSeptember 07, 2023

Drug manufacturing licensing requirements

The United States is a world leader in drug discovery and development. But, in recent years, drug manufacturing has increasingly moved offshore to countries like India and China.

To reverse the offshore trend and revitalize American manufacturing, the U.S. Department of Health and Human Services (HHS) plans to establish a DPA Title III Protection to provide financial aid to build and expand the health resources industrial base.

If you’re a drug manufacturer or thinking of starting this type of business, you will be subject to federal and state government licensing laws. These laws also extend to anyone who distributes, dispenses, and sells prescription drugs and devices.

To ensure you are compliant, here is an overview of the registration process and drug manufacturer licensing requirements in the United States.

Federal requirements

If you own or operate a drug or pharmaceutical manufacturing establishment, you are required to register it with the Food and Drug Administration (FDA) at least five days after starting operations. According to the FDA, a drug manufacturer is anyone who is engaged in manufacturing, preparing, propagating, compounding, processing, packaging, repackaging, or labeling of a prescription drug.

As part of the registration process, you must list each drug manufactured by your company that is intended for commercial distribution and submit this information to the FDA twice a year, in June and December, and notify the agency if any information has changed.

Registration renewal occurs between October 1 and December 31 each year. However, listing updates can occur at any time during the year.

If your business involves controlled substances, you are subject to additional requirements. For example, if you distribute, store, or manufacture a named controlled substance, you must apply for a federal controlled substances registration issued by the Drug Enforcement Agency (DEA). A separate DEA registration is also required for each place of business or practice at a physical location where controlled substances are manufactured. This registration is subject to annual renewal.

State requirements for business licenses

A drug manufacturing license is required at the state level. These laws and license types vary from state to state. For example, depending on your state, you may need a manufacturer license, wholesale distributor license, or pharmacy facility license.

If you deal with controlled substances, separate state licensing and permit requirements exist.

When applying for a drug manufacturer license, you must provide the following information:

  • Proof of FDA drug establishment registration
  • Corporate documents
  • Certificate of Good Standing
  • Proof of registered agent
  • Facility plans or construction drawings
  • Description of security system and security measures in place
  • Facility manager information
  • Self-inspection report
  • List of drugs to be manufactured/repackaged
  • Copy of VAWD certificate
  • Lease/zoning statement
  • Certificate of insurance

Before a license is issued, the state could also require a facility inspection.

State licensing requirements for virtual manufacturers

Many states now require licensure of virtual manufacturers. A virtual drug manufacturer sells its own prescription drugs, products, and/or devices but outsources the manufacturing and distribution process. (I.e., they never take possession of the product.)

Many states include virtual manufacturers in the same compliance bucket as wholesalers. These licensing requirements can be very specialized, and you may choose to request certain exemptions.

Licensing requirements for change of ownership

If your business undergoes a change of ownership, depending on the state in which you operate, you may be required to notify the appropriate pharmacy board of the change.

To continue operations, some states also require an application for a new license. If the application is received within a certain timeframe, the facility can typically continue operating until the new license is issued.

However, there are exceptions, and some states do not allow continued operations after closure of the original business or change of ownership if the application is pending.

Because these laws are complex and vary, it’s best to consult a legal services provider who can identify the actions your company must take in accordance with regulations and guide you through the process.

Do cosmetic manufacturers need a drug manufacturing license?

Certain cosmetic products meet the definition of both cosmetics and drugs. This generally happens when a product has two intended purposes. For example, an anti-dandruff shampoo is considered a drug since it’s a dermatological treatment. This is also the case with toothpaste, deodorants that contain antiperspirants, moisturizers and makeup advertised with sun protection claims. Such products must comply with licensing requirements for drugs and cosmetics.

CT Corporation can help

CT Corporation can help you stay up to date with changing requirements and forms so you can focus on running a successful drug or pharmaceutical manufacturing business. We complete license applications efficiently and correctly, so you don’t spend time chasing down the proper licenses. Once your drug manufacturing license has been issued, we ensure that you remain compliant will all licensing laws.

To learn more about how CT Corporation can help you manage your business license needs, contact a CT Corporation Service Representative or call (844) 878-1800.

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Hans Howk
Manager, Content Management
Hans provides internal support to key members of the Business Licensing Team, assisting with understanding industry nuances, searching and synthesizing statutes and regulations relating to business law.
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