Pharmaceutical manufacturers are subject to various federal and state government licensing laws. These laws also extend to anyone who distributes, dispenses, and sells prescription drugs or medical devices.
To ensure you are compliant, here is an overview of the registration process and drug manufacturer licensing requirements in the United States.
Drug manufacturers operating in the United States are subject to federal requirements governing establishment registration, drug listing, and ongoing manufacturing standards. These requirements are administered by the FDA.
If you own or operate a drug manufacturing establishment, you must register it with the FDA within five calendar days after beginning operations. Those required to register include manufacturers, repackers, relabelers, and salvagers of drugs. Registration must be submitted electronically unless the FDA grants a waiver.
Registration must be reviewed and updated annually during the period of October 1 through December 31. This review must reflect all changes that have occurred since the prior annual review. If no changes have occurred, you must certify that the information remains current.
Certain changes require an update within 30 calendar days:
Only a registrant may designate a new official contact or United States agent, though any of those parties may notify the FDA of changes to contact information.
In July 2026, the FDA issued a proposed rule that would modernize drug establishment registration. The rule would create a streamlined registration pathway for distributed facilities that operate as a single establishment under a hub-and-spoke model. It would also clarify registration and drug listing requirements for certain foreign establishments that manufacture drugs (including active pharmaceutical ingredients) that indirectly enter the U.S. drug supply. This would give the FDA visibility into foreign suppliers earlier in the supply chain. Manufacturers should monitor this rule as it moves toward finalization.
Controlled substances
If your business involves controlled substances, you are subject to additional federal requirements administered by the Drug Enforcement Administration (DEA), separate from FDA registration. Any person or business that manufactures, distributes, stores, imports, exports, or dispenses a controlled substance must obtain a federal controlled substance registration from the DEA. A separate registration is required for each physical location where these activities occur. DEA registrations are subject to annual renewal.
In addition to registering your establishment, you must list each drug your company intends for commercial distribution. Each drug must be listed no later than three calendar days after initial establishment registration.
Drug listing information must be reviewed and updated each June and December to report any changes since the last reporting. This includes new drugs not yet listed, discontinued drugs, or material changes to a listed drug. (21 CFR § 207.57)
During the annual renewal window from October 1 through December 31, registrants must renew their establishment registration and certify any drug listings that had no changes during the calendar year. (21 CFR § 207.29, 21 CFR § 207.57).
Failure to update or certify listings on schedule can result in the FDA marking the listing as inactive and removing it from the National Drug Code Directory.
A note on upcoming changes to the National Drug Code
In March 2026, the FDA published a final rule standardizing the National Drug Code (NDC) to a uniform 12-digit format, replacing the current variable 10-digit format. The rule takes effect March 7, 2033, followed by a three-year transition period from March 7, 2033, to March 6, 2036.
While the FDA will automatically convert existing NDC records in its listing database on the effective date, manufacturers are responsible for updating their physical product labeling and related systems. Planning for these changes should begin well in advance of the effective date.
cGMP regulations set minimum standards for the methods, facilities, and controls used in manufacturing, processing, and packing drug products. These requirements are designed to ensure that products are safe and accurately reflect the ingredients and strength stated on their labeling.
cGMP compliance also factors into the drug approval process. FDA reviewers assess a manufacturer’s cGMP record as part of their evaluation of new and generic drug marketing applications, including whether the facility has the equipment and capabilities required to produce the drug it intends to market.
In addition to federal registration, a drug manufacturing license is required at the state level. License types and requirements vary by state. Depending on where you operate, you may need a manufacturer license, wholesale distributor license, or pharmacy facility license. If you deal with controlled substances, separate state licensing and registration requirements also apply.
When applying for a drug manufacturer license, you may need to provide the following:
Before a license is issued, the state could also require a facility inspection.
A virtual drug manufacturer sells prescription drugs or devices under its own label but outsources the actual manufacturing and distribution process. State licensing requirements for this business type vary significantly and are continuing to evolve.
States take different approaches to virtual manufacturer licensing. Some have created a dedicated license category for virtual manufacturers. Others accommodate virtual manufacturers through separate application tracks within an existing manufacturer or wholesale distributor license. Some states do not require licensure of virtual entities at all.
Where licensure is required, many states classify virtual manufacturers alongside wholesale distributors rather than traditional manufacturers. Because requirements and terminology differ significantly by state, companies operating in multiple states should verify the applicable license type and requirements with each state’s board of pharmacy.
A change of ownership may trigger notification and licensing obligations depending on the state in which you operate. Most states require notifying the appropriate board of pharmacy when a transfer of ownership occurs.
Some states also require an application for a new license to continue operations. If the application is submitted within a specified timeframe, the facility can typically continue operating while the new license is being processed. However, some states do not permit continued operations following a change of ownership if a license application is pending.
Because these requirements vary and the consequences of non-compliance can be significant, consulting a legal services provider familiar with state pharmacy regulations is advisable.
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 because it functions as a dermatological treatment. This is also the case with toothpaste, deodorants that contain antiperspirants, moisturizers, and makeup advertised with sun protection claims. Products in this category must comply with registration and licensing requirements for both drugs and cosmetics.
Facilities producing these dual-purpose products must complete federal drug establishment registration with the FDA and hold the appropriate state drug manufacturing or wholesale licenses.
Manufacturers whose products do not meet the definition of a drug are not subject to drug licensing requirements. However, they must still comply with FDA cosmetic regulations under the Modernization of Cosmetics Regulation Act (MoCRA), including facility registration, product listing, and Good Manufacturing Practice standards.
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 licensing needs, contact a CT Corporation Service Representative.
