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  3:30:54 AM 12/10/2024
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Over the Counter Drug Manufacturer

An over-the-counter (OTC) drug manufacturer engages in the manufacturing or repackaging of an OTC drug in Florida.

Application Requirements:
 
  • What is "manufacturing"? In this context, the term means the preparation, deriving, compounding, propagation, processing, producing or fabrication of any OTC drug.

  • What is "repackaging"? The term includes repacking or otherwise changing the container, wrapper, or labeling to further the distribution of the OTC drug. A few examples:

    • Altering a packaging component that is or may be in direct contact with the drug, device, or cosmetic. For example, repackaging from bottles of 1000 to bottles of 100.
    • Altering a manufacturer's package for sale under a label different from the manufacturer. For example, a kit that contains an injectable vaccine from manufacturer A; a syringe from manufacturer B; alcohol from manufacturer C; and sterile gauze from manufacturer D packaged together and marketed as an immunization kit under a label of manufacturer Z.
    • Altering a package of multiple-units, which the manufacturer intended to be distributed as one unit, for sale or transfer to a person engaged in the further distribution of the product. This does not include:

        • Selling or transferring an individual unit which is a fully labeled self-contained package that is shipped by the manufacturer in multiple units, or

        • Selling or transferring a fully labeled individual unit, by adding the package insert, by a person authorized to distribute prescription drugs to an institutional pharmacy permit, health care practitioner or emergency medical service provider for the purpose of administration and not for dispensing or further distribution.

  • What is NOT a "manufacturer"? A Florida-licensed pharmacy operating in compliance with pharmacy practice standards under the Florida Pharmacy Act, Chapter 465, Florida Statutes.

  • Distributors - No Permit Required: Florida law does NOT require any permit for the distribution of OTC drugs - only the manufacturing. However, OTC drug distributors must keep and maintain sales and other distribution records.

  • FDA Establishment Registration: The applicant must have an FDA establishment registration number, or provide documentation supporting an exemption from FDA registration.

  • APPLICATION: Complete the application by clicking on the "Printable Application" link at the bottom of the page.

  • Inspection: Passing an onsite inspection is a prerequisite to issuance of this permit, unless the applicant holds a Prescription Drug Manufacturer permit for the establishment.

  • License Term: Prescription Drug Manufacturer permits are valid through the last day of the initial issuance month in the second year of licensure. Example: A permit issued on September 12, 2011 would be valid through September 30, 2013.

  • Fee: The application and permitting fee is $800 for a two-year permit, plus a one-time pre-permit inspection fee of $150. Make checks payable to DBPR. The inspection fee applies only to new permits.

  • Product Registration: Florida law requires that all drugs manufactured in this state must be registered with the department before sale. Product registration is NOT a prerequisite to issuance of this permit.


If you have any questions or need assistance in completing this application, please contact the Drugs, Devices, and Cosmetics Program Office at 850.717.1800.


Apply Using Online Services


Apply Using a Printable Application
2601 Blair Stone Road, Tallahassee FL 32399 :: Email: Customer Contact Center :: Customer Contact Center: 850.487.1395

The State of Florida is an AA/EEO employer. Copyright ©2023 Department of Business and Professional Regulation - State of Florida. Privacy Statement

Under Florida law, email addresses are public records. If you do not want your email address released in response to a public-records request, do not send electronic mail to this entity. Instead, contact the office by phone or by traditional mail. If you have any questions, please contact 850.487.1395. *Pursuant to Section 455.275(1), Florida Statutes, effective October 1, 2012, licensees licensed under Chapter 455, F.S. must provide the Department with an email address if they have one. The emails provided may be used for official communication with the licensee. However email addresses are public record. If you do not wish to supply a personal address, please provide the Department with an email address which can be made available to the public. Please see our Chapter 455 page to determine if you are affected by this change.