DIVISION OF DRUGS, DEVICES AND COSMETICS
Out-of-State PRESCRIPTION DRUG WHOLESALE DISTRIBUTOR
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.
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 a $100,000 surety bond, or provide other equivalent means of security acceptable to the Department, such as an irrevocable letter of credit or an assignment of certificate of deposit in a trust account or financial institution, payable to the Florida Drugs, Devices and Cosmetic Trust Fund. If posting the bond, refer to “Surety Bond Form” effective June 2005.
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, to the Department as part of the application process. Refer to the “Personal Information Statement” effective January 2004. 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.
- “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:
License Term: Out-of-State Prescription Drug Wholesale Distributor permits are renewed annually, valid through the last day of the initial issuance month in the following year. Example: A permit issued on September 12, 2011 would be valid through September 30, 2012.
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.
Fees: The application and permitting fee is $800 for a one-year permit. Make checks payable to DBPR. An applicant or permittee may be assessed an inspection fee in the event of an inspection.
If you have any questions or need assistance completing these forms, please call the Drugs, Devices and Cosmetics Program at (850) 717-1800.
Application Currently Unavailable Using Online Services