11/20/23, 4:28 PM Drug Manufacturer License Requirements | Wolters Kluwer

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COMPLIANCE SEPTEMBER 07, 2023

Drug manufacturing licensing requirements

By: Hans Howk

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The United States is a world leader in drug discovery and

  Business license
development. But, in recent years, drug manufacturing has
managed services
increasingly
  moved offshore to countries like India and
CT Corporation manages the
China. lifecycle of all your business
 
licenses and provides ongoing
support for your core business
license program.
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
Managed Services Details 
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
EXPERT INSIGHTS
subject to federal and state government licensing laws. These laws also extend to
anyone who distributes, dispenses, and sells prescription drugs and devices. Stay informed
Subscribe to CT
To ensure you are compliant, here is an overview of the registration process and drug Corporation's
manufacturer licensing requirements in the United States.
newsletters for
business compliance
updates and legislative
news.

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Drug manufacturing licensing  Access resources

requirements
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Learn the business license state requirements
for drug manufacturing

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Contact CT Corporation
Contact us today for business
Federal requirements registration and business
compliance assistance.
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
Contact a Specialist 
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.
R E L AT E D I N S I G H TS

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
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the FDA twice a year, in June and December, and notify the agency if any information SOLUTIONS DIRECTORY CAREERS INVESTORS

has changed.
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Registration renewal occurs between October 1 and December 31 each year. However,
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listing updates can occur at any time during the year.
Money transmitter business license
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requirements (smart chart)

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If your business involves controlled substances, you are subject to additional
requirements. For example, if you distribute, store, or manufacture a named controlled Third-party logistics provider licensing
requirements 
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 Wholesale drug distributor licensing
requirements 
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:
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Proof of FDA drug establishment registration SOLUTIONS DIRECTORY CAREERS INVESTORS

Corporate documents
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Certificate of Good Standing

 of registered agent
 Proof

Facility plans or construction drawings

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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
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product.)

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Many states include virtual manufacturers in the same compliance bucket as SOLUTIONS DIRECTORY CAREERS INVESTORS

wholesalers. These licensing requirements can be very specialized, and you may
 
choose to request certain exemptions.

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Licensing requirements for change of ownership
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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? 

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Certain cosmetic products meet the definition of both cosmetics and drugs. This SOLUTIONS DIRECTORY CAREERS INVESTORS

generally happens when a product has two intended purposes. For example, an anti-
 shampoo is considered a drug since it’s a dermatological treatment. This is
dandruff
also the case with toothpaste, deodorants that contain antiperspirants, moisturizers
 advertised with sun protection claims. Such products must comply with
 makeup
and
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 (866) 906-3192.

Please complete the form below for access to the smart chart:

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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
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COMPLIANCE November 14, 2023 COMPLIANCE LEGAL November 14, 2023

Corporate Transparency Act checklist for Why incorporate in Delaware, Nevada, or

small businesses Wyoming?
Use this CTA checklist as a guide to help determine if As you think about where to incorporate a business or
your business has to file a beneficial ownership report. form an LLC, you may be considering Delaware,
Nevada, or Wyoming.

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