PPLE 3.2 Florida Pharmacy Permits

Florida Pharmacy Permits

• Permits are necessary for entities involved in the creation of drugs and devices.

Manufacturing Permits

• Prescription Drug Manufacturer Permit: Required to manufacture and distribute prescription drugs in Florida; virtual permit available if no physical possession, must maintain adequate records, and comply with state/federal regulations.
• Non-Resident Rx Drug Manufacturer Permit: Required for manufacturers outside Florida (including the U.S.) distributing prescription drugs in Florida; virtual permit available if no physical possession, must be licensed/permitted in their location, comply with security/storage rules if taking possession, and have FDA approval for foreign imports.
• Over-the-Counter Drug Manufacturer Permit: Required for manufacturing or repackaging OTC drugs in Florida; no virtual permit available and may not possess/purchase prescription drugs, must comply with state/federal GMPs, with exemptions for pharmacies compliant with Florida practice standards.
• Device Manufacturer Permit: Required for manufacturing, repackaging, or assembling medical devices for human use in Florida; no virtual permit available, exempt if pursuant to a practitioner's order for a specific patient or if registered with the FDA, and must comply with state/federal GMPs.
• Cosmetic Manufacturer Permit: Required for manufacturing or repackaging cosmetics in Florida; no virtual permit available, exempt if only adding or changing labels without opening the sealed container.
• Virtual permits are available for prescription drug manufacturers (both, in-state and non-resident) who do not take physical possession of the drugs and virtual permit holders are exempt from certain building security and storage requirements.
• Blood banks manufacturing only prescription drugs for blood donation and processing are exempt from the prescription drug manufacturer permit requirements.
• Non-resident manufacturers importing drugs from a foreign country must provide the Department of Health (DOH) with a list and document FDA approval.

Distribution Permits

• These permits are necessary for entities involved in the wholesale distribution of drugs.
• Prescription Drug Wholesale Distributor Permit: Required for any person who wholesale distributes prescription drugs in Florida; requires physical possession.
• Distributor Broker Permit: Issued to those who wholesale distribute prescription drugs but do not take physical possession; it is an alternative to the Prescription Drug Wholesale Distributor Permit.
• Out-of-State Rx Drug Wholesale Distributor Permit: Required for wholesale distributors outside Florida (but within the U.S. or its territories) that distribute prescription drugs into Florida; must have a license or permit in their state of residence or a federal wholesale distributor license if their state doesn't require one.
• Retail Pharmacy Drug Wholesale Distributor Permit: Required for retail pharmacies that wholesale distribute drugs, permitted if less than 30% of annual sales are distributed to other entities, otherwise a standard Prescription Drug Wholesale Distributor Permit is required.
• Veterinary Rx Drug Wholesale Distributor Permit: Required for anyone distributing veterinary prescription drugs in Florida; If also distributing human prescription drugs they didn't manufacture, they may need a standard or out-of-state Rx drug wholesale distributor permit or a limited veterinary wholesale distributor permit instead, and must comply with rules for wholesale distributors.
• Complementary Rx Drug Distributor Permit: Required for distributing free drug samples to physician's offices, etc.
• Taking physical possession is a key differentiator between some permit types, such as the standard wholesale distributor and the distributor broker.
• The 30% threshold is crucial for retail pharmacies engaging in wholesale distribution, determining which type of wholesale distributor permit they need.
• Out-of-state distributors must adhere to licensing requirements in their home state or obtain a federal license.

Restricted Prescription Drug Distributor Permit

• This permit is required for specific scenarios that are not considered standard wholesale distribution, such as receiving or distributing a drug in Florida for processing its return or destruction if not the initiator, supplier, or manufacturer.
• This permit is also for blood establishments collecting blood and components from volunteer donors or under a practitioner's order for treatment/therapy and the receiving entity must be a closed pharmacy or provide healthcare services.
• Covered drug types for blood establishments includes drugs for bleeding disorders, blood collection containers, blood derivatives, essential drugs for blood establishments, and drugs necessary for donor and patient care.
• Exemptions are not required for distribution between commonly owned pharmacies with active permits operating in freestanding or end-stage renal dialysis clinics under specific emergency conditions that are not regular or systematic.
• Permittees must observe Florida rules for wholesale distributors.

Repackaging Permits

• These permits are for entities that repackage prescription drugs.
• Prescription Drug Repackager Permit: Required for anyone in Florida that repackages prescription drugs and can distribute the repackaged drugs, must comply with all rules applying to a prescription drug manufacturer and all state and federal GMPs.
• Non-Resident Rx Drug Repackager Permit: Required for those outside Florida (but within the U.S. or its territories) who repackage and distribute prescription drugs into Florida, must comply with rules for manufacturers, have a DOH permit, comply with all state and federal GMPs, and be registered as a drug establishment with the FDA.
• Repackagers must generally adhere to the same rules and regulations as prescription drug manufacturers.

Transport and Shipping Permits

• These permits are for entities involved in the transportation and logistics of prescription drugs.
• Freight Forwarder Permit: Required for those who distribute prescription drugs as a freight forwarder (managing all shipping, including multiple modes), and not required for common carriers like the US Postal Service, must comply with storage, handling, and record-keeping requirements for wholesale distributors, must provide documentation of exportation.
• Third Party Logistics Provider Permit: Required for those contracting with manufacturers or wholesale distributors to provide warehousing, distribution, or other logistics without taking title or directing sale, the providers outside Florida must be licensed in their state or territory, or federally if their state doesn't require a license, and must comply with Florida storage and record rules.

Veterinary Permits

• These permits are specific to the distribution and sale of veterinary prescription drugs.
• Veterinary Rx Drug Retail Establishment Permit: Required for selling veterinary prescription drugs to the public without a pharmacy license and must be based on a valid written order from a Florida-licensed veterinarian with a valid client-veterinarian relationship.
• The amount or date of the order cannot be exceeded (valid for no more than one year), they cannot sell, purchase, trade, or possess human prescription drugs or controlled substances, must sell in the original sealed manufacturer's container, must comply with wholesale distribution requirements and drugs cannot be returned to inventory.
• Veterinary Rx Drug Wholesale Distributor Permit: Required for anyone distributing veterinary prescription drugs in Florida, and may need a standard or out-of-state Rx drug wholesale distributor permit or a limited veterinary wholesale distributor permit if also distributing human prescription drugs they didn't manufacture and must comply with wholesale distributor rules.
• Limited Prescription Drug Veterinary Wholesale Distributor Permit: Allows distributing veterinary prescription drugs under specific limited conditions if not permitted as a standard drug manufacturer or distributor, conditions include to licensed veterinarians practicing full-time, those instructing veterinary medicine, law enforcement, non-clinical research, or for chemical analysis/testing/instruction.
• Restrictions include no more than 30% of annual drug sales can be human prescription drugs and cannot distribute drugs subject to 503B of the FDCA to those authorized for human use.
• The bond required is a $20,000 bond for new or renewal permits, must have a wholesale distributor license in their state of residence and comply with Florida storage/record rules and cannot return 503B drugs to inventory.

Healthcare Clinic Establishment Permit

• This permit is required for healthcare or veterinary clinics to purchase prescription drugs.
• Purpose: Allows a place of business providing healthcare or veterinary services by a Florida-licensed practitioner to purchase prescription drugs at one physical location.
• Designated Practitioner: Must designate a qualifying practitioner responsible for all legal and regulatory compliance related to purchasing, record-keeping, storage, and handling therefore this designation and any changes must be reported to the DOH within 10 days.
• Separate Permit per Establishment: Each location requires a separate permit.
• Not a Pharmacy Permit: This permit does not equate to a pharmacy permit. Clinics meeting the criteria of a modified Class II institutional pharmacy are not eligible for this permit.
• Practitioner Purchases: This permit is not required for a licensed practitioner purchasing drugs under their own license.
• Several exceptions exist for distributing prescription drug active pharmaceutical ingredients for research, teaching, or testing to permitted manufacturers in Florida or holders of a letter of exemption, with specific labeling requirements ("Caution: Research and Development Only..." or "Caution: Research, Teaching, or Testing Only...") and record-keeping.
• Intra-company Transfers: An out-of-state wholesale distributor permit is not required for intra-company sales or transfers between licensed wholesale distributors under the same business name.
• Requirements for Recipients Claiming Exemption: Entities receiving drugs from a source claiming exemption must maintain records of FDA registration, the source's license/permit, and the most recent inspection report, also they must make all related records available to the DOH within 48 hours and report any misbranded or adulterated products within 14 days.
• Repackaging Exception for Restricted Distributors: A prescription drug repackager permit is not required for a restricted prescription drug distributor (healthcare entity) to repackage for its own use or distribution to commonly controlled hospitals/healthcare entities under specific notification, GMP, and labeling conditions.