Drug Manufacturer License Requirements | Wolters Kluwer


Federal requirements

If you own or operate a drug or pharmaceutical manufacturing facility, you must register it with the Food and Drug Administration (FDA) at least five days after you begin operations. According to the FDA, a drug manufacturer is anyone engaged in manufacturing, compounding, propagating, compounding, processing, packaging, repackaging, or labeling 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.

Renewal of registration takes place between October 1 and December 31 of each year. However, list updates may 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 Substance 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 types of licenses vary from state to state. For example, depending on your state, you may need a manufacturer’s license, a wholesale distributor’s license, or a pharmacy license.

If you are dealing with controlled substances, separate licensing and permit requirements exist.

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

  • Proof of registration of the pharmaceutical establishment with the FDA
  • Corporate documents
  • Certificate of good standing
  • Proof of registered agent
  • Installation plans or construction drawings
  • Description of the 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
  • Insurance certificate

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

State Licensing Requirements for Virtual Makers

Many states now require virtual makers to be licensed. A virtual drug maker sells its own prescription drugs, products, and/or devices, but outsources the manufacturing and distribution process. (That is, they never take possession of the product.)

Many states include virtual manufacturers in the same compliance compartment 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 in ownership, depending on the state in which you operate, you may need to notify the appropriate board of pharmacy of the change.

To continue operations, some states also require an application for a new license. If the request is received within a certain timeframe, the installation can usually continue to operate until the new license is issued.

However, there are exceptions and some states do not allow business to continue after the original business closes or changes ownership if the application is pending.

Since these laws are complex and vary, it is best to consult with a legal service provider who can identify the steps your business must take under the regulations and guide you through the process.

Do cosmetic manufacturers need a drug manufacturing license?

Some cosmetic products meet both the definition of cosmetics and drugs. This usually happens when a product has two purposes. For example, an anti-dandruff shampoo is considered a drug since it is a dermatological treatment. This is also the case with toothpastes, deodorants that contain antiperspirants, moisturizers and makeup advertised with sunscreen claims. These products must comply with licensing requirements for drugs and cosmetics.

CT can help

CT Corporation can help keep you current 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 waste time searching for the right licenses. Once your drug manufacturing license has been issued, we ensure that you remain compliant with all licensing laws.

To learn more about how CT Corporation can help you manage your commercial licensing needs, contact a CT Corporation service representative or call (844) 701-2064.


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