Drug Manufacturing Permits in Florida

• Five types of permits apply to drug manufacturers.

Prescription Drug Manufacturing Permit (Florida Based)

• Required for manufacturers with corporate headquarters in Florida that manufacture/distribute prescription drugs.
• A virtual permit is available for manufacturers who don't take physical possession of the drug.
• Issued by the Board of Pharmacy/Department of Health.
• Manufacturers must comply with state and federal regulations and maintain adequate records.
• Virtual permit holders are exempt from certain building security and storage rules but must still comply with requirements regarding temperature, security, and storage to preserve potency.
• Blood banks manufacturing prescription drugs solely for blood donation and processing are exempt.

Non-Resident Prescription Drug Manufacturer Permit

• Applies to manufacturers with corporate headquarters outside Florida who distribute prescription drugs in Florida.
• A virtual permit is available if the non-resident manufacturer does not take possession of the drug.
• Virtual permit holders are exempt from securities and storage rules.
• Requires manufacturers to be licensed or permitted to manufacture drugs in their state/country of origin.
• A distributor, without manufacturing responsibilities, requires an out-of-state prescription drug wholesale distributor permit or a third-party logistics provider permit.
• Non-resident manufacturers importing drugs into Florida must provide a list and FDA approval documentation to the Department of Health for each drug.

Over the Counter (OTC) Drug Manufacturer Permit

• Required for OTC drug manufacturers domiciled in Florida.
• There is no out-of-state version of this permit.
• Required for anyone who makes or repackages an over-the-counter drug in Florida.
• OTC drug manufacturers cannot possess or purchase prescription drugs.
• Pharmacies operating under Florida pharmacy practice standards are exempt.
• OTC drug manufacturers must comply with state and federal good manufacturing practices (GMPs).

Device Manufacturer Permit

• Required for Florida companies manufacturing medical devices.
• Exemptions exist for devices made per practitioner orders for specific patients or if the manufacturer is FDA registered.
• Manufacturers and repackagers must comply with state and federal GMPs.

Cosmetic Manufacturer Permit

• Required for manufacturers that make or repackage cosmetics in Florida.
• An exemption exists if only adding or changing the label of a cosmetic without ever opening the container sealed by the original manufacturer.

Prescription Drug Wholesale Distributor Permit

• Required for anyone who wholesale distributes prescription drugs in Florida.
• An out-of-state version is required for entities located outside Florida.

Distributor Broker Permit

• Issued by the Department of Health to those who wholesale distribute prescription drugs without taking physical possession.

Out-of-State Prescription Drug Wholesale Distributor Permit

• Required for anyone who wholesales or distributes prescription drugs out of Florida but within the US or its territories, into Florida.
• Requires the distributor to have a license or permit in their state of residence (if outside Florida).
• Requires licensing as a wholesale distributor as required by the Food Drug and Cosmetic Act (FDCA) if the state of origin does not require a permit.
• Excludes intra-company sales/transfers between licensed wholesale distributors under the same business name.

Retail Pharmacy Drug Wholesale Distributor Permit

• Allows retail pharmacies within certain limits to wholesale distribute drugs.
• Requires the standard prescription drug wholesale distributor permit if equal to or greater than 30% of annual sales are distributed to other entities
• It can be obtained if under 30% of annual sales are distributed to other pharmacies or hospitals
• Requires the transfer of drugs to be between two retail pharmacies, to a modified class two institutional pharmacy, or to a healthcare practitioner licensed in Florida and authorized to dispense or prescribe prescription drugs.
• Sales records of prescription drugs wholesale distributed must be maintained separately from other records.

Restricted Prescription Drug Distributor Permit

• Required in Florida for anyone who distributes a prescription drug that is not considered to be wholesale distribution.
• Applies to receiving or distributing a drug in Florida for processing its return or destruction.
• Requires distributors not to be the initiator of the return, the wholesale supplier, or the drug manufacturer.
• It is a separate license from other manufacturing and distributor permits.
• This permit covers drugs for bleeding or clotting disorders or anemia, blood protection collection containers approved under the FDCA, blood derivative drugs or recombinant or synthetic blood derivatives, prescription drugs identified in Florida Department of Health rules essential to blood establishment services and federally authorized for their distribution, and drugs necessary to collect blood or components from volunteer donors for blood establishment personnel to perform therapeutic procedures under physician supervision and to manage reactions of blood donors or patients.
• Requires blood establishments collecting from volunteer donors or under practitioner orders to operate under this permit.
• Drugs permissible to be purchased and possessed without a healthcare clinic establishment permit if within approved conditions.
• Requires holders to observe Florida rules for wholesale distributors.
• Waived for distribution between commonly owned pharmacies in freestanding end-stage renal dialysis clinics for immediate emergency needs (not for batching) and not as a regular supply.
• A prescription drug repackager permit is not required for a restricted prescription drug distributor permit holder that is a healthcare entity to repackage prescription drugs in Florida for its own use or distribution to hospitals or other healthcare entities for their own use, provided certain conditions are met.
• Common control is defined as the power to direct management and policies through ownership, voting rights, contract, or otherwise.

Veterinary Prescription Drug Wholesale Distributor Permit

• Required for anybody distributing veterinary prescription drugs in Florida.
• If also distributing prescription drugs subject to the federal FDCA (that they did not manufacture), they also need a prescription drug wholesale distributor permit, an out-of-state prescription drug wholesale distributor permit, or a limited prescription drug veterinary wholesale distributor permit instead of this one.
• Requires holders to comply with the rules for wholesale distributors as specified under Chapter 499 of Florida Statutes.

Limited Prescription Drug Veterinary Wholesale Distributor Permit

• Allows the distribution of veterinary prescription drugs in Florida only under specific conditions unless permitted as a prescription drug manufacturer or distributor.
• Allows wholesaling to: licensed veterinarians practicing full-time, those regularly and lawfully instructing veterinary medicine, those regularly and lawfully engaged in law enforcement activities, for use in research not involving clinical use, or for use in chemical analysis or physical testing for instruction in law enforcement, research, or testing.
• No more than 30% of total annual drug sales can be prescription drugs approved for human use; otherwise, a different permit is required.
• The permit holder cannot distribute prescription drugs subject to 503B of the federal FDCA (related to compounding) to anyone authorized to sell, distribute, purchase, trade, or use these drugs on or for humans.
• The applicant for a new or renewal of this permit must submit a bond of at least $20,000.
• The holder must maintain a license or permit to wholesale distribute prescription drugs in their state of residence (if outside Florida).
• They must comply with all Florida building storage and record rules for wholesale distributors.
• They may not return to inventory for wholesale distribution any drug subject to 503B of the federal FDCA that has been returned by a veterinarian.

Complimentary Prescription Drug Distributor Permit

• This permit is for the distribution of free samples that drug representatives give to physician practices.

Florida Prescription Drug Repackager Permit

• Required for anybody in Florida that repackages a prescription drug and distributes prescription drugs repackaged at that establishment.
• Requires compliance with rules for prescription drug manufacturers and state/federal GMPs.

Non-Resident Prescription Drug Repackager Permit

• Required if located outside of Florida but within the United States or its territories, repackaging and distributing prescription drugs into Florida.
• Requires compliance with manufacturer rules, state/federal GMPs, and registration as a drug establishment with the US Food and Drug Administration.

Freight Forwarder Permit

• Required for entities controlling all aspects of shipping prescription drugs using multiple transport modes, excluding common carriers like the US Postal Service.
• Requires compliance with storage, handling, and record-keeping for wholesale distributors.
• Requires providing the source of the prescription drugs with a validated airway bill of lading or other appropriate documentation to evidence exportation of the product.

Third Party Logistics Provider Permit

• Required for entities providing warehousing, distribution, or logistics for prescription drugs without taking ownership or directing sales.
• Third-party logistics providers outside Florida must be licensed in the state or territory from which the drug is distributed; if not required in the shipping state, they must be licensed as a logistics provider by the Federal FDCA.
• Requires compliance with Florida storage and record rules.

Retail Veterinary Establishment Permit

• Required for establishments without a pharmacy permit that sell veterinary prescription drugs to the public.
• Requires a valid written order from a Florida-licensed veterinarian based on a client-veterinarian relationship.
• Restrictions on the amount and validity period (one year max) of the written order.
• Prohibits the sale, purchase, trade, or possession of human prescription drugs or controlled substances.
• Requires sale in the original sealed manufacturer's container with intact labeling.
• Requires compliance with wholesale distribution requirements.
• Prohibits the return of prescription drugs sold under a practitioner's order into the retailer's inventory.

Healthcare Clinic Establishment Permit

• Required for a place of business providing healthcare or veterinary services by a Florida-licensed practitioner to purchase prescription drugs.
• Requires designating a qualifying practitioner responsible for compliance with legal and regulatory requirements.
• Requires the designated practitioner's name, establishment address, and license number on all distribution documents.
• Requires notification to the Department of Health within 10 days of any change in the designated practitioner.
• Requires a separate permit for each establishment.
• This is not a pharmacy permit and does not apply to modified class two institutional pharmacies.
• A non-resident prescription drug manufacturer permit is not required for a manufacturer to distribute a prescription drug active pharmaceutical ingredient that it manufactures to a prescription drug manufacturer permitted in Florida for research and not for resale or human clinical use (other than lawful clinical trials and bio studies authorized by federal law).
• Those claiming exemption who distribute within or into Florida must make all records related to any prescription drugs distributed under this subsection available to the Department of Health within 48 hours, regardless of where the records are stored.
• A person purchasing and receiving a prescription drug from someone claiming exemption must report to the Department of Health in writing within 14 days after receiving any product that is misbranded or adulterated or fails to meet minimum standards in official compendia or state/federal GMPs for identity, purity, potency, or sterility, regardless of the product's subsequent handling.