Drug Manufacturer License

Drug manufacturing companies must register at the state and federal level. It is crucial for pharmaceutical production companies to operate within relevant laws. Here is an overview on the registration process and licensing requirements in each state.

The pharmaceutical industry is one of the most profitable and influential. Today’s drug manufacturers strive to understand how disease and infection are controlled at the molecular level. Pharmaceutical companies that manufacture drugs are commercial businesses licensed to research and develop drugs, most commonly in the context of healthcare. They may deal in generic or brand name medications. When it comes to the means of drug manufacturing, the process involves milling, granulation, coating, and tablet pressing.

Obtaining a drug manufacturing license is only a part of the process to running a fully operational company. Both state and federal laws impact the registration, licensing, and operation process. Federally regulated businesses that may need to obtain drug manufacturing licenses are involving in the following industries:

• Animal and veterinary pharmaceuticals
• Cosmetics
• Medical devices
• Radiation-emittting products
• Tobacco products
• Vaccines, blood, and biologics

Virtual drug manufacturing is also an option for those looking to start a business in pharmaceuticals. Virtual manufacturers own the product, but someone else manufactures it on contract or at their facility. It is the actual manufacturer that needs to be licensed in the state in which they produce the products.

How to Get Licensed to Manufacture Drugs and Devices

In the United States, domestic and foreign companies that manufacture drug products are strictly regulated at the federal and state levels. If you are looking to register your business and obtain the necessary licensing to operate, it is important to follow the process step-by-step. To start, you will need to register with the FDA.

Whether you’re looking to outsource to experts or manage your licenses internally, Harbor Compliance has the tools to help. With our Managed Licensing Services, you can entrust your license management to us while having program visibility and in-depth research capabilities. The same easy-to-use SaaS platform can be used to consolidate and manage your corporate and individual license portfolios. If you are interested in learning more, schedule a brief demonstration.

Registering With the Food and Drug Administration

You need to comply with federal guidelines before you start registering your business with the state in which you plan to operate. Per the Food and Drug Adminstration Amendments Act of 2007, drug establishment registration must be submitted online unless a waiver is granted.

All drug manufacturers, foreign and domestic, are required to register their business and list all their drug products in commercial distribution in the United States. Registration is required at least five days after starting operations. Along with the registration form, the owner or operator must also provide a drug application, biological license application, or medicated feed mill license application, depending on the type of business.

Registrants are also required to renew and update the information for their business on or before December 31 of each year. Additional updates must be provided every June if relevant changes take place between renewal periods.

Filing Procedures

Once you are appropriately registered with the FDA, you can focus on state registration. State laws vary, so it is vital to be aware of what rules apply to your business. However, in most states, the filing procedures follow this general path:

• Documentation. Before applying, there are a number of documents applicants have to obtain and get attested by the appropriate authorities.
• Applying online. In most states, the drug license application takes place online. Applicants may visit the official website of their respective state authority, upload the required forms, and pay a processing fee. In a few states, applicants are required to print their application and supporting documents, and send them to their district licensing office.
• Authority verification. Once an application has been submitted and processed, a drug inspector will visit the premises to verify the location is suitable for manufacturing drugs. The drug inspector may also call the applicant to conduct a formal interview.
• Issues of drug license. Once the application and verification processes are complete, the Controller of Drugs will issue a drug manufacturing license. The applicants receive a unique registration number they use for further processing and reference.

Prerequisites and Required Documents

A significant number of documents are required upon applying for a drug manufacturer license. While state requirements vary, most applications will ask for the following:

• Approved manufacturing premises layout
• Constitutional documents
• Cover letter including brief detail about the manufacturing process
• Disclosure of manufacturing activities
• Disclosures of standards followed by the company for product evaluation
• Proof of an appointed registered agent to receive notices of lawsuit and other legal notices
• Full disclosures of competent and regular technical staff
• Full quality assurance certificate
• Owner identification and address
• ISO certificate
• Particulars of medical devices being manufactured
• Proof of property ownership
• Proof of property possession
• Site master file and device master file
• Specific environmental requirements

It is crucial to have all the required documents before submitting your application. This will ensure the process goes as smoothly as possible. Failing to include even one of the required documents could result in a significant processing delay.

The Benefits of Obtaining a Manufacturing Drug License

Filing for a drug manufacturing license ensures your company operates legally under state and federal regulations. However, that is not the only advantage. Other benefits include:

• Proof of authenticity. Licenses help authorities monitor and regulate the manufacturing of drugs, which ultimately enhances business credibility and trustworthiness.
• Consumer confidence. A drug manufacturer that holds the proper licenses proves to consumers that the business follows quality measures and the drug is safe to consume under physician supervision.

Explore Licensing by State

Click on a link below to view licensing information in your state.

Meeting the drug manufacturing license requirements is not always an easy process. Fortunately, Harbor Compliance’s License Manager and our managed service solutions help pharmaceutical companies maintain their licenses by automating or outsourcing repetitive tasks such as tracking renewals and other compliance requirements. Through License Manager, you can also access Compliance Core™ - our extensive, proprietary database of nationwide licensing information - to research the requirements for the states in which you work. These tools reduce the time you spend researching state requirements and prepare your organization for success. Contact out licensing experts today to learn more.