DIVISION OF DRUGS, DEVICES AND COSMETICS
PRESCRIPTION DRUG WHOLESALE DISTRIBUTOR
A prescription drug wholesale distributor is a wholesale distributor located in Florida that may engage in the wholesale distribution of prescription drugs in this state.
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 State of Florida, Department of Business and Professional Regulation (DBPR). 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 “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.
Primary Wholesaler Determination: All applicants acting as a primary wholesaler must complete the “Primary Wholesaler Determination Form”. Chapter 499.012(1) F.S. defines a “Primary Wholesaler” as any wholesale distributor that: 1. Purchased 90 percent or more of the total dollar volume of its purchases of prescription drugs directly from manufacturers in the previous year; and 2. a. Directly purchased prescription drugs from not fewer than 50 different prescription drug manufacturers in the previous year; or b. Has, or the affiliated group, as defined in s. 1504 of the Internal Revenue Code, of which the wholesale distributor is a member has, not fewer than 250 employees.
Application: Businesses seeking this permit must complete the appliication by clicking on the "Printable Application" link at the bottom of the page. Mail or deliver the application and all required attachments to:
Inspection: Passing an onsite inspection is a prerequisite to issuance of this permit.
License Term: 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.
Fee: The application and permitting fee is $800 for a one-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.
If you have any questions or need assistance completing these forms, please call the Drugs, Devices and Cosmetics Program at (850) 717-1800.
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