An out-of-state prescription drug wholesale distributor is a wholesale distributor located outside this state engaging in the wholesale distribution of prescription drugs into this state. Requirements: Intracompany Transactions – Limited Exemption from Licensure: This permit IS NOT required for an intracompany sale or transfer of a prescription drug from an out-of-state establishment that is duly licensed as a prescription drug wholesale distributor, in its state of residence, to a licensed prescription drug wholesale distributor in this state, if both wholesale distributors conduct wholesale distributions of prescription drugs under the same business name.
- Note: Certain Florida-specific recordkeeping requirements, set forth in Sections 499.0121(6) and 499.01212, Florida Statutes still apply to these transactions.
Certified Designated Representative (CDR): All applicants and permittees must designate in writing at least one natural person to serve as the designated representative. Such person must have an active certification from the Department. A permittee may not operate for more than 10 business days without employing a CDR, and must notify the Department within 10 days of a CDR’s separation. Certification and operating requirements for CDR’s:
- Submit a CDR application and pay the appropriate fees.
- Be at least 18 years of age.
- Have not less than two years of verifiable full-time work experience in a pharmacy licensed in this state or another state, where the person’s responsibilities included, but were not limited to, recordkeeping for prescription drugs, or have not less than two years of verifiable full-time managerial experience with a prescription drug wholesale distributor licensed in this state or in another state.
- Receive a passing score of at least 75 percent on an examination given by the department regarding federal laws governing distribution of prescription drugs and this part and the rules adopted by the department governing the wholesale distribution of prescription drugs.
- Employed in a managerial position by the wholesale distributor, and actively involved in and aware of actual daily operations.
- Physically present at the establishment during normal business hours, except for time periods when absent due to illness, family illness or death, scheduled vacation, or other authorized absence.
- May serve as a designated representative for only one wholesale distributor at any one time.
Surety Bond: All applicants and permittees must post evidence of a surety bond in this state or any other state in the United States in the amount of $100,000. If the annual gross receipts of the applicant’s previous tax year are $10 million or less, evidence of a surety bond in the amount of $25,000. The specific language of the surety bond must include the State of Florida as a beneficiary, payable to the Professional Regulation Trust Fund. In lieu of the surety bond, the applicant may provide other equivalent security such as an irrevocable letter of credit, or a deposit in a trust account or financial institution, which includes the State of Florida as a beneficiary, payable to the Professional Regulation Trust Fund.
Personal Information Statements: Certain individuals associated with applicants and permittees must provide a personal information statement, including a set of fingerprints for a criminal background check, as part of the application process. The Department must collect personal information statements from (i) the CDR or CDR candidate; (ii) the manager of the establishment, and the next four highest ranking employees responsible for prescription drug wholesale operations at the establishment, and (iii) all “affiliated parties” of the establishment. The Personal Information Statement is the located at the end of the wholesale application. Out of State Prescription Drug Wholesale Distributor Application pages 19-33 (Personal Information Statement)
- “Affiliated Parties” includes: (i) directors, officers, trustees, partners, or committee member of a permittee or applicant or a subsidiary or service corporation of the permittee or applicant; (ii) any person who, directly or indirectly, manages, controls, or oversees the operation of a permittee or applicant, regardless of whether such person is a partner, shareholder, manager, member, officer, director, independent contractor, or employee of the permittee or applicant; and (iii) up to five natural individual owners, to the extent that any owns at least five percent of the permittee or applicant.
- Resident State Licensure: Applicants must submit a photocopy of the resident state’s license or permit that authorizes the wholesale distribution of prescription drugs. If the resident state does not allow photocopying of the license or permit, the applicant may submit a verification of the license or permit from the issuing agency. If the resident state does not require a license or permit for the wholesale distribution activities of the applicant in that state, submit: (i) a written confirmation on the letterhead of the resident state agency responsible for regulating prescription drug wholesale distribution in that state that permitting of the applicant establishment is not required by that state; and (ii) a statement signed by the applicant that the applicant will comply with all storage, handling, and recordkeeping requirements of the resident state related to the sale and physical distribution of prescription drugs into Florida, or if none exist in the resident state, that the applicant will comply with all storage, handling, and recordkeeping requirements, as set forth in 21 C.F.R. 205.50 (as of 10/1/03), for the sale and physical distribution of prescription drugs into Florida.
Application: Businesses seeking this permit must complete the Department’s application. Mail or deliver the application and all required attachments to: Florida Department of Business and Professional Regulation Drugs, Devices and Cosmetics Program 2601 Blair Stone Road Tallahassee, FL 32399-1047 Inspection: Passing an onsite inspection is not a prerequisite to issuance of this permit, although the department may conduct a pre-permit or routine inspection of an out-of-state establishment. Fee: The overall application and permitting fee is $800 per year equating to a $1,600.00 fee for two year licenses. Make checks payable to DBPR. An applicant or permittee may be assessed an inspection fee in the event of an inspection.
All requests for publications, documents, forms, applications for licenses, permits and other similar certifications can be obtained by contacting the Customer Contact Center.
Walter Copeland, Division Director
Division of Drugs, Devices and Cosmetics
2601 Blair Stone Road
Tallahassee, FL 32399-1047