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.
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.
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.
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/.
Steps to Opening
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.
The Internal Revenue Service (IRS) is the nation’s tax collection agency and administers the Internal Revenue Code enacted by Congress.
Steps to Opening
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.
You may apply for an EIN online if your principal business is located in the United States or U.S. Territories. The person applying online must have a valid Taxpayer Identification Number (SSN, ITIN, EIN). You are limited to one EIN per responsible party per day.
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.
Steps to Opening
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.
Register your business to report newly hired, re-hired or temporary employees within 20 days of an employee’s start date.
The Department of Revenue’s Child Support Program works with employers in a variety of ways to ensure compliance with child support orders when applicable. Employers must work with the Child Support Program to respond to income withholding requests and to enroll children in medical insurance plans. Once registered with the New Hire Reporting Center, businesses will be able to access the Child Support Employer Services website to report employee termination and bonus or lump sum payments, request replacement copies of income withholding notices currently in place for employees, and use the Program’s online calculator to get pro-rated child support amounts for employees that have more than one child support case.
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.
Most corporations and certain entities conducting business, or who are incorporated in Florida, including out-of-state corporations, must file a Florida corporate income tax return.
Register online or by submitting a Florida Business Tax Application (Form DR-1), or by filing the Florida Corporate Income/Franchise Tax Return (Form F-1120).
Reemployment Assistance gives partial, temporary income to workers who lose their jobs through no fault of their own and are able and available for work. If your business will employ workers in Florida, you may register online or submit a Florida Business Tax Application (Form DR-1).
Before conducting business, anyone selling, renting, leasing or repairing goods, providing certain services, charging admissions, or renting or leasing short-term lodging, housekeeping accommodations, or commercial real property must register with the Department of Revenue.
Additionally, use tax is due on the use or consumption of taxable goods or services when sales tax was not paid at the time of purchase.
Register online or by submitting a Florida Business Tax Application (Form DR-1).
This surtax, imposed by most Florida counties, applies to most transactions subject to sales or use tax. Businesses must also collect the applicable discretionary sales surtax from the purchaser at the time of sale, then report and remit it to the Department of Revenue.
No additional registration is required.
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/.
Steps to Opening
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.
Prepares, derives, manufactures, or produces a prescription drug and/or distributes such prescription drugs in Florida.
Prepares, derives, compounds, propagates, processes, produces, fabricates or repackages any over-the-counter (OTC) drug in Florida.
Prepares, derives, compounds, propagates, processes, produces fabricates or repackages any medical gas in Florida.
Repackages or otherwise changes the container, wrapper or labeling to further the distribution of a prescription drugs in Florida.
Prepares, derives, manufactures, or produces a prescription drug and/or distributes such prescription drugs outside of Florida or outside the United States and that engages in the wholesale distribution of such prescription drugs into Florida.
Prepares, derives, produces, synthesizes, otherwise makes ether in any form or repackages , relabels or manipulates diethyl ether in Florida.
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.
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.
Steps to Opening
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.
Steps to Opening
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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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:
- Prescription drugs (both brand-name and generic)
- Non-prescription (over-the-counter) drugs
- Vaccines for humans
- Blood and blood products
- Cellular and gene therapy products
- Tissue and tissue products
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
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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