Overview

This industry comprises businesses primarily engaged in one or more of the following: (1) manufacturing biological and medicinal products, (2) processing (i.e., grading, grinding, and milling) botanical drugs and herbs, (3) isolating active medicinal principals from botanical drugs and herbs, and (4) manufacturing pharmaceutical products
intended for internal and external consumption.

Business types included in this category:
  • Pharmaceutical and Medicine Manufacturing

    This industry comprises establishments primarily engaged in one or more of the following: (1) manufacturing biological and medicinal products; (2) processing (i.e., grading, grinding, and milling) botanical drugs and herbs; (3) isolating active medicinal principals from botanical drugs and herbs; and (4) manufacturing pharmaceutical products intended for internal and external consumption in such forms as ampoules, tablets, capsules, vials, ointments, powders, solutions, and suspensions.

General Considerations

Before starting a business, you probably will need to register with the Florida Department of State, the IRS and the Florida Department of Revenue. For businesses located outside of the State of Florida, evidence of registration with their Division of Corporations or Corporate Registry may be required.

After completing these steps, you will need to get the appropriate license from the Department of Business and Professional Regulation.

Businesses in this category should check with the Department of Environmental Protection for applicable air, water and waste permits.

Business owners in this category may also wish to explore assistance offered by the Florida Department of Economic Opportunity.

Get Started

The following represents your interactive licensing checklist for this business category. Select the expandable blue bars below for more information on the specific licenses, permits or registrations that may be required to open your business. We have also included a printable version of the following checklist available at the top of this page for your convenience.

Register your business with the Department of State

Department of State

The Florida Department of State’s Division of Corporations serves as the state’s central depository for a number of commercial activities. These activities include a variety of business entity filings, trade and service mark registrations, federal lien recordings, judgment lien filings, uniform commercial code financing statements, fictitious name registrations, notary commissions, and cable and video service franchises.

To file a complaint regarding a business or person licensed by this agency, please see their website.  To obtain this agency’s public records, visit: https://www.dos.myflorida.com/offices/general-counsel/public-records-requests/.

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Agency Introduction

The Department of State (DOS) is where you register your business. You can search and access filed information for corporations, limited liability companies, limited partnerships, general partnerships, trademarks, fictitious name registrations and liens. Also, electronic filing and certification can be processed via the Department’s website.


  • Manufacturing: Pharmaceuticals, Drugs and Medicine

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Apply for your Employer Identification Number (EIN)

Internal Revenue Service

The Internal Revenue Service (IRS) is the nation’s tax collection agency and administers the Internal Revenue Code enacted by Congress.

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Agency Introduction

If you are required to report employment taxes or give tax statements to employees, you need an Employer Identification Number (EIN) to send with all items you report to the Internal Revenue Service (IRS) or Social Security Administration. If you do not intend to hire others, you may skip this step.


  • Manufacturing: Pharmaceuticals, Drugs and Medicine

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Register your business with the Department of Revenue

Department of Revenue

The Florida Department of Revenue administers three programs: general tax administration, property tax oversight and child support. The general tax administration program works with Florida businesses that are required to register for, collect, report and remit the taxes and fees administered by the Department.

The Department also manages the State of Florida’s New Hire Reporting Center. Federal and state laws require employers to report newly hired, re-hired and temporary employees within 20 days of an employee’s start date. This information is used to assist the Department’s child support program with child support orders. The employment information reported through the state’s New Hire Reporting Center is also used to detect and prevent public assistance and reemployment assistance fraud.

For additional information, please visit floridarevenue.com.

To file a complaint regarding a business or person licensed by this agency, please see their website.  To obtain this agency’s public records, visit:https://floridarevenue.com/opengovt/Pages/default.aspx.

 

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Agency Introduction

A business owner or contractor may need to register for, collect, report and/or remit one or more of the taxes, fees and licenses administered by the Florida Department of Revenue. This is dependent on the structure of a business, the activities of a business, and whether the business hires employees. In addition, businesses must report newly hired, re-hired and temporary employees through the State of Florida’s New Hire Reporting program managed by the Florida Department of Revenue.


Reporting Employment Information

The Department manages the State of Florida’s New Hire Reporting Center. Federal and state laws require employers to report newly hired, re-hired and temporary employees within 20 days of an employee’s start date. The Department’s Child Support program utilizes employment information and employer cooperation to assist with child support order compliance. The reported employment information through the state’s New Hire Reporting Center is also used to detect and prevent public assistance and reemployment fraud.

  • Manufacturing: Pharmaceuticals, Drugs and Medicine

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Business Taxes, Fees and Surcharge

Businesses in this category may be required to register for, collect, report and/or remit one or more of the following taxes and fees.

  • Manufacturing: Pharmaceuticals, Drugs and Medicine

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Apply for a license from the Department of Business and Professional Regulation

Department of Business and Professional Regulation

The Florida Department of Business and Professional Regulation (DBPR) is the agency charged with licensing and regulating businesses and professionals in Florida. A variety of businesses will need to coordinate with DBPR to obtain applicable licenses, registrations and/or permits.

To file a complaint regarding a business or person licensed by this agency, please see their website.  To obtain this agency’s public records, visit: http://www.myfloridalicense.com/dbpr/instant-public-records/.

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Agency Introduction

DBPR’s Division of Drugs, Devices, and Cosmetics provides manufacturer permits for prescription drugs and cosmetics under this category.


Division of Drugs, Devices, and Cosmetics

This division safeguards the health, safety, and welfare of the citizens of the state of Florida from injury due to the use of adulterated, contaminated, misbranded drugs, drug ingredients and cosmetics.

Certain controlled substance distributors must submit monthly distribution reports to DBPR.  The affected companies distribute controlled substances (Florida Statue Section 499.0121(14) Schedules II-V, inclusive) in or into Florida.

  • Manufacturing: Pharmaceuticals, Drugs and Medicine

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Apply for a permit from the Department of Environmental Protection

Department of Environmental Protection

The Florida Department of Environmental Protection (DEP) is the agency charged with safeguarding Florida’s environment. Manufacturers, agriculture-related professionals and environmentalists will need to coordinate with DEP to obtain applicable licenses, registrations and/or permits.

To file a complaint regarding a business or person licensed by this agency, please see their website.  To obtain this agency’s public records, visit: https://floridadep.gov/sec/sec/content/public-records.

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  • Manufacturing: Pharmaceuticals, Drugs and Medicine

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Explore assistance from the Department of Economic Opportunity (optional)

Department of Economic Opportunity

In collaboration with our partners, the Florida Department of Economic Opportunity (DEO) assists the Governor in advancing Florida’s economy by championing the state’s economic development vision and by administering state and federal programs and initiatives to help visitors, citizens, businesses, and communities.

To file a complaint regarding a business or person licensed by this agency, please see their website.  To obtain this agency’s public records, visit: https://floridajobs.org/about-us/who-we-are-and-what-we-do/requests-for-public-records.

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Agency Introduction

The Department of Economic Opportunity (DEO) utilizes public and private sector expertise to attract, retain and grow businesses and create jobs in Florida. It also provides valuable resources for businesses and entrepreneurs; assistance with recruiting workers; and statistical information regarding Florida businesses and employment. Your business may qualify for various state or federal assistance.


  • Manufacturing: Pharmaceuticals, Drugs and Medicine

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Additional Local Government Information

County Business Requirements

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Explore Federal Licensing Considerations

Federal Business Requirements

In addition to state and local licensing, many business activities are also regulated by federal agencies.  Businesses within this category may also be required to obtain additional federal licenses, permits, registration, etc. depending on your specific business activities.  It is recommended that you consult with a professional (e.g., attorney, CPA, SBA, etc.) to ensure you meet all requirements before starting your business.  The U.S. Small Business Administration is an excellent resource for potential and current business owners seeking assistance navigating federal licensing requirements.  For more information on the Federal Government, please visit www.usa.gov.

In most cases, you will need not need a license to import or export services or goods into or from the US.  However, international transfer of certain goods may require a license, permit or certification.  All items are subject to export control laws and regulations.  For more information, please visit USA.gov’s importing and exporting page.

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U.S. Food & Drug Administration

The Food and Drug Administration (FDA) is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation. The FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. The FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health. The FDA also plays a significant role in the Nation’s counterterrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats.

The FDA regulates various types of businesses, including:

Drugs, including:

  • Prescription drugs (both brand-name and generic)
  • Non-prescription (over-the-counter) drugs

Biologics, including:

  • Vaccines for humans
  • Blood and blood products
  • Cellular and gene therapy products
  • Tissue and tissue products
  • Allergenics

Medical Devices, including:

  • Simple items like tongue depressors and bedpans
  • Complex technologies such as heart pacemakers
  • Dental devices
  • Surgical implants and prosthetics

Veterinary Products, including:

  • Veterinary drugs and devices

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U.S. Drug Enforcement Administration, Diversion Control Program

Many of the narcotics, depressants, and stimulants manufactured for legitimate medical use are subject to abuse and have, therefore, been brought under legal control. Under federal law, all businesses that import, export, manufacture, or distribute controlled substances; all health professionals licensed to dispense, administer, or prescribe them; and all pharmacies authorized to fill prescriptions must register with the DEA. Registrants must comply with regulatory requirements relating to drug security and recordkeeping. The DEA is also obligated under international treaties to monitor the movement of licit controlled substances across U.S. borders and to issue import and export permits for that movement.

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Disclaimer: The State of Florida operates OpenMyFloridaBusiness.gov as a public service to Florida residents and visitors worldwide. While efforts were made to verify that the content of this website is accurate and comprehensive, it is recommended that you consult with a professional (e.g., attorney, CPA, SBDC, etc.) to ensure you meet all requirements before starting your business. OpenMyFloridaBusiness.gov is not responsible for the content of external websites.