Florida Regulations 61N-1.015: Licensing, Application, Permitting
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This section addresses the application and permitting requirements of persons regulated under part I of chapter 499, F.S.
(1) Any person that is required under sections 499.001-.081, F.S., to have a permit shall apply to the department for the appropriate permit on forms indicated in this rule. Inquiries regarding requests for an application or licensing may be directed to The Department of Business and Professional Regulation, Drugs, Devices, and Cosmetics Program, 2601 Blair Stone Road, Tallahassee, Florida 32399-1047 or telephone number (850)717-1800. Applications may be downloaded from the bureau’s web site at www.myfloridalicense.com.
(2) A permit is valid only for the name and address to which it is issued. The name in which a permit is issued will be changed, at no cost, upon notification to the department.
(a) The name in which the permit is issued must be the name in which the company is doing business, i.e., the name that appears on purchase and sales invoices.
(b) A permit that authorizes the purchase of prescription drugs will not be issued in a name identical to the name used by any other establishment or licensed permit holder at that address authorized to purchase prescription drugs pursuant to chapter 465, F.S., or the statutes regulating a practitioner authorized to purchase prescription drugs except:
1. A Restricted Rx Drug Distributor – Charitable Organization permit will be issued in the name of the charitable organization or health care entity, and
2. A Medical Oxygen Retailer permit may be issued in the name of a nursing home’s Class I Institutional Pharmacy permit.
(c) A person must be available for inspection at the permitted address during the business hours identified on the application form, holidays excluded. Permanent changes to these business hours must be communicated to the department in writing. At a minimum, these business hours must meet the following standards:
1. For an establishment applying for a permit or permitted as a prescription drug wholesaler or prescription drug wholesaler – broker only, the establishment must designate a minimum of 20 hours weekly between the hours of 8:00 a.m. and 5:00 p.m. (EST), Monday through Friday, and at least one day of the week provide for four consecutive hours.
2. For an establishment applying for a permit or permitted only as a medical oxygen retailer and which does not transfill medical oxygen containers at the permitted establishment, the establishment must designate a minimum of four (4) hours weekly between the hours of 8:00 a.m. and 5:00 p.m. (EST), Monday through Friday, and at least one day of the week provide for two consecutive hours. Furthermore if less than 10 hours weekly are designated, a medical oxygen retailer must be available by telephone between the hours of 8:00 a.m. to 5:00 p.m., Monday through Friday, to schedule an appointment within 24 hours of the department’s telephone call for an inspection during non-designated business hours.
3. Other applicants and permitted establishments must designate a minimum of 10 hours weekly between the hours of 8:00 a.m. and 5:00 p.m. (EST), Monday through Friday, and at least one day of the week provide for two consecutive hours. These standards set forth minimum business hours and agents of the Department of Business and Professional Regulation and the Department of Law Enforcement may inspect, monitor, and investigate during other hours as authorized by law.
(3) On-site Inspections. Passing an on-site inspection is a prerequisite to issuance of a new permit for the following permit types: Prescription Drug Manufacturer, Device Manufacturer, Compressed Medical Gases Manufacturer, Over-the-Counter Drug Manufacturer, Cosmetic Manufacturer, Prescription Drug Wholesaler, Compressed Medical Gases Wholesaler, Freight Forwarder, Veterinary Prescription Drug Wholesaler located in Florida, Veterinary Legend Drug Retailer, Medical Oxygen Retailer, and Restricted Rx Drug Distributor permits for the Health Care Entity, Reverse Distributor, and Destruction facilities. However, the department may elect to perform an inspection of the Restricted Rx Drug Distributor – Charitable Organization, Government Program, or Institutional Research as a condition of permitting but an on-site inspection fee will not be assessed.
(a)1. A person permitted as a Prescription Drug Manufacturer that is applying for additional manufacturing permits, a Complimentary Drug Distributor permit, or a Prescription Drug Wholesaler permit at that address does not require another on-site inspection and is not required to pay an initial application/on-site inspection fee when applying for the additional permits.
2. A person permitted as an Over-the-Counter Drug Manufacturer that is applying for a Device Manufacturer permit or Cosmetic Manufacturer permit at that address does not require another on-site inspection and is not required to pay an initial application/on-site inspection fee when applying for the additional permit.
3. A person permitted as a Cosmetic Manufacturer or Device Manufacturer that is applying for a Device Manufacturing permit or Cosmetic Manufacturing permit does not require another on-site inspection and is not required to pay an initial application/on-site inspection fee when applying for the additional permit.
(b) A person permitted as a Compressed Medical Gases Manufacturer that is applying for either a Compressed Medical Gases Wholesaler permit or a Medical Oxygen Retailer permit at that address does not require another on-site inspection and is not required to pay an initial application/on-site inspection fee when applying for the additional permit.
(c) A person permitted as a Medical Oxygen Retailer that is applying for a Compressed Medical Gases Wholesaler permit at that address does not require another on-site inspection and is not required to pay the initial application/on-site inspection fee when applying for the additional permit. A person permitted as a Medical Oxygen Retailer that has the establishment registered with the FDA for transfilling activity which is applying for a Compressed Medical Gases Manufacturer’s permit at that address does not require another on-site inspection and is not required to pay the initial application/on-site inspection fee when applying for the additional permit.
(d) The department will request from the applicant written documentation to evidence compliance with the requirements of chapter 499, F.S., when an on-site inspection cannot be completed within 30 days of receipt of a completed application for a permit requiring an on-site inspection or a written request for a change of address.
(4) Written policies and procedures as required by chapter 499, F.S., and this rule chapter must be established prior to approval of a permit application. A prescription drug wholesaler that uses a system to digitally sign and electronically authenticate an electronic pedigree must have policies and procedures to protect the security over the digital signatures.
(5) Notification to the department regarding the change of address of a permitted establishment must be in writing. A Change of Address form is available on the department’s web site. Notification regarding the closing of a permitted establishment shall also include the name and address of a person to contact for up to two years after the closing of the business for access to required records.
(6) Manufacturer Permits.
(a) A prescription drug manufacturer’s permit, over-the-counter drug manufacturer’s permit, or device manufacturer’s permit is not required for the manufacture of products that are in an FDA approved investigational program and that are not manufactured for clinical investigation (for actual use in or on humans or animals).
(b) A device manufacturer’s permit is required for an establishment that refurbishes medical devices for subsequent sale but is not required when the refurbishing is performed as a service for the owner of the medical device and the device is returned to the owner for further use.
(c) Application requirements for manufacturers and precription drug repackagers located in Florida include:
1. Contact the department’s Drugs, Devices, and Cosmetics Program to request an application or download the application from the department’s website.
2. File with the department a completed application for a permit using an original Form DH 1033, “”Application for Permit Under chapter 499, F.S.,”” effective August 2004, which is incorporated by reference herein.
3. Pay the appropriate fee(s) as required by Fl. Admin. Code R. 61N-1.018
4. Comply with all the requirements for permitting provided in chapter 499, F.S., and this rule chapter.
5. Have an FDA establishment registration number, or unless the application is for a cosmetic manufacturer, provide documentation to the department supporting an exemption from FDA registration.
(d) Application requirements for Non-resident prescription drug (Rx) manufacturers.
1. A person may qualify as a Non-resident Rx drug manufacturer if
a. The establishment is not located in Florida; and
b.(I) The person and establishment physically manufacture a prescription drug either for itself or as a contract manufacturer; or
(II) The person is the holder of an approved New Drug Application (NDA), Abbreviated New Drug Application (ANDA), or New Animal Drug Application (NADA); or
(III) The person and establishment is a private label distributor and the private label distributor’s prescription drugs are originally manufactured and labeled for the distributor and have not been repackaged; or
(IV) The establishment is the distribution point for the manufacturer, contract manufacturer or private label distributor whether the establishment is a member of the manufacturer’s affiliated group or is a contract distribution site; or
(V) The person and establishment import prescription drugs, including active pharmaceutical ingredients also referred to as bulk ingredients that are lawful in interstate commerce.
2. A non-resident Rx drug manufacturer that also distributes prescription drugs that it did not manufacture (as meeting one of the criteria above) will also need to apply for an out-of-state prescription drug wholesaler permit and meet all of the requirements for obtaining that permit.
3. Contact the department’s Drugs, Devices, and Cosmetics Program to request an application or download the application from the department’s website.
4. File with the department a completed application for a permit using an original Form DH 1033, “”Application for Permit Under chapter 499, F.S.,”” effective August 2004.
5. Submit a photocopy of all permits or licenses issued to the applicant’s address which authorize the manufacture or possession of prescription drugs at that address, regardless of the issuing agency. If the issuing agency prohibits photocopying the permit or license, the applicant may submit a state verification of any permits or licenses issued to the applicant’s address.
6. If the non-resident Rx drug manufacturer is importing prescription drugs, FDA approval can be documented with:
a. An NDA number for the product; or
b. Evidence of an FDA establishment number for the manufacturing site and inclusion of the particular product on the manufacturer’s drug listing with the FDA; or
c. For an active pharmaceutical ingredient, evidence that the manufacturer’s bulk drug substance is identified as an ingredient in an FDA approved finished product; or
d. Other direct evidence of FDA authorization for the importation and commercial distribution of the product.
Updates to the list of prescription drugs being imported and documentation of FDA approval must be submitted to the department prior to importation of any prescription drug under the non-resident Rx drug manufacturer’s permit. It is the non-resident manufacturer’s responsibility to assure that it is only importing approved prescription drugs into Florida and is complying with Florida Statutes § 499.023 Compliance with submission of the information required in this rule does not mean that the prescription drug does in fact comply with all provisions of the Federal Act and chapter 499, F.S., and may be imported.
7. Pay the appropriate fee(s) as required by Fl. Admin. Code R. 61N-1.018
8. Comply with all the requirements for permitting provided in chapter 499, F.S., and this rule chapter.
(7) Wholesaler Permits.
(a) A person applying for or renewing a permit as a prescription drug wholesaler, or as a veterinary prescription drug wholesaler located in Florida, must have an area for the storage of prescription drugs under controlled room temperature and refrigeration, as required by Fl. Admin. Code R. 61N-1.013(3)(d), whether or not the person intends to wholesale prescription drugs requiring storage under controlled room temperature conditions or refrigeration; except that a person who will act as a broker only of prescription drugs may apply for a “”broker only”” designation on the Prescription Drug Wholesaler permit and then the requirement that the permitted address provide for “”controlled room temperature”” and refrigeration is waived. A “”broker only”” cannot take possession of prescription drugs under any circumstances.
(b) The Prescription Drug Wholesaler’s bond and the bond for an out-of-state prescription drug wholesaler will be transferred by the department to subsequent permits issued pursuant to renewal applications if the bond or other equivalent means of security is in a form that will allow for such transfer. The bond will be refunded without interest, consistent with the provisions of Florida Statutes § 499.012(2) In order for another means of security to satisfy the bond requirement, the security must be in a form that the applicant or permittee cannot revoke, withdraw, cancel, or otherwise reduce the department’s interest until the conditions upon which the bond can be refunded or released, as set forth in Florida Statutes § 499.012(2), have been satisfied. If the bond or other security is in a form that requires the department to initiate release of the bond or security, a prescription drug wholesaler or out-of-state prescription drug wholesaler should request in writing that the department release the bond or security within 45 days of satisfaction of the conditions in sections 499.012(2)(a) and (c), F.S., that release department’s interest in the bond or other security. The department must initiate release of the bond or security within 10 working days of satisfaction of the conditions in sections 499.012(2)(a) and (c), F.S., unless the department has otherwise made a claim against the bond or security.
(c) A Prescription Drug Wholesaler is authorized to wholesale all prescription drugs, including compressed medical gases and therefore does not require dual permits.
(d) Application requirements for Compressed Medical Gases Wholesalers include:
1. Contact the department’s Drugs, Devices, and Cosmetics Program to request an application or download the application from the department’s website.
2. File with the department a completed application for a permit using an original Form DH 1033, “”Application for Permit Under chapter 499, F.S.,”” effective August 2004.
3. Pay the appropriate fee(s) as required by Fl. Admin. Code R. 61N-1.018
4. Comply with all the requirements for permitting provided in chapter 499, F.S., and this rule chapter.
(e) Application requirements for Prescription Drug Wholesalers, Prescription Drug Wholesalers – Broker Only, or Out-of-State Prescription Drug Wholesalers include:
1. Contact the department’s Drugs, Devices, and Cosmetics Program for an application form(s) and fingerprint cards. Both the sales transaction (seller) and the physical movement (location from which the drugs are shipped) of prescription drugs are considered wholesale distribution. Therefore, if the seller (name and address as reflected on the invoice) is not the same as the location from which the drugs are shipped (name and address), such as in the case of brokers, different branches of the same company, or a contract warehouse, then both persons (the seller and location from which shipped) must be permitted under the Florida Drug and Cosmetic Act.
2. File with the department a completed application for a permit using an original Form DH 2124, “”Prescription Drug Wholesaler/Out-of-State Prescription Drug Wholesaler Application”” effective January 2004, which is incorporated by reference herein.
3. File with the department an original Form DH 2125, “”Personal Information Statement”” effective January 2004, which is incorporated by reference herein for the applicant’s manager, next four highest ranking employees that are responsible for prescription drug operations, and all affiliated parties.
4. Submit a legible fingerprint card and $47.00 per fingerprint card for each person required to submit a fingerprint card. These fingerprint cards must have been obtained from the department so that the cards will have the proper coding for processing and reporting.
5. Submit a $100,000 bond or security as specified in sections 499.012(2)(a) and (c), F.S., and paragraph (b), above. If you are using a surety bond, the required bond form is DH 2128, “”Surety Bond Form,”” effective June 2005, which is incorporated by reference herein.
6. If the applicant is located outside of Florida, 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:
a. 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
b. 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) which is incorporated by reference herein, for the sale and physical distribution of prescription drugs into Florida.
7. Identify a person who has been Certified pursuant to Florida Statutes § 499.012(11), to serve as the certified designated representative. If the prescription drug wholesaler operates in ‘shift’ schedules, a different person per shift may be designated; however the shift hours for which each person is responsible must be clearly identified. You must use Notification of Designated Representative Form DH 2130, effective June 2005, which is incorporated by reference herein, for communicating changes in the designated representative.
8. Pay the appropriate fee(s) as required by Fl. Admin. Code R. 61N-1.018
9. Comply with all the requirements for permitting provided in chapter 499, F.S., and this rule chapter.
(f) Application requirements for Retail Pharmacy Wholesalers include:
1. Contact the department’s Drugs, Devices, and Cosmetics Program to request an application or download the application from the department’s website.
2. File with the department a completed application for a permit using an original Form DH 1033, “”Application for Permit Under chapter 499, F.S.,”” effective August 2004.
3. Submit a photocopy of all permits issued to the applicant’s address which authorize the purchase of prescription drugs at that address, regardless of the issuing agency.
4. Pay the appropriate fee(s) as required by Fl. Admin. Code R. 61N-1.018
5. Comply with all the requirements for permitting provided in chapter 499, F.S., and this rule chapter.
(g) Application requirements for freight forwarders.
1. Contact the department’s Drugs, Devices, and Cosmetics Program to request an application or download the application from the department’s website.
2. File with the department a completed application for a permit using an original Form DH 1033, “”Application for Permit Under chapter 499, F.S.,”” effective August 2004.
3. Pay the appropriate fee(s) as required by Fl. Admin. Code R. 61N-1.018
4. Comply with all the requirements for permitting provided in chapter 499, F.S., and this rule chapter.
(h) Application requirements for Veterinary Prescription Drug Wholesalers include:
1. Contact the department’s Drugs, Devices, and Cosmetics Program to request an application or download the application from the department’s website.
2. File with the department a completed application for a permit using an original Form DH 1033, “”Application for Permit Under chapter 499, F.S.,”” effective August 2004, and the attachment for the Veterinary Prescription Drug Wholesaler permit, August 2004.
3. Pay the appropriate fee(s) as required by Fl. Admin. Code R. 61N-1.018
4. Comply with all the requirements for permitting provided in chapter 499, F.S., and this rule chapter.
(8) Other Distributors. Persons conducting certain distributions of prescription drugs which are not considered wholesale distributions in the state of Florida must obtain a permit from the department prior to initiating that activity. These permits include Complimentary Drug Distributors, all of the designated Restricted Rx Drug Distributor permits as further discussed in Fl. Admin. Code R. 61N-1.023, Medical Oxygen Retailers, and Veterinary Legend Drug Retailers.
(a) Application requirements for Complimentary Drug Distributors include:
1. Contact the department’s Drugs, Devices, and Cosmetics Program for an application form or download the application from the department’s website. An out of the state manufacturer or distributor of complimentary or sample prescription drugs may obtain a “”Complimentary Drug Distributor permit”” for its headquarters or home office in lieu of a permit for each establishment from which complimentary prescription drugs are distributed. A manufacturer or distributor that uses a fulfillment house, shipping and mailing service, or distributes through co-marketing agreements, must notify the department in writing of the contractor’s name, address, and responsibilities prior to the distribution of prescription drug samples in or into this state. The headquarters or home office location is responsible for all recordkeeping requirements and for production of such records as required by sections 499.0121 and 499.028, F.S., this rule and Fl. Admin. Code R. 61N-1.012 A person located within the state that manufactures or distributes complimentary or sample prescription drugs directly or through its agents, employees, or independent contractors, must obtain a Complimentary Drug Distributor permit for each establishment located in Florida. A manufacturer or distributor that uses a fulfillment house, shipping and mailing service, or distributes through co-marketing agreements, any of which is located in Florida, must obtain a permit in the name of the manufacturer or distributor issued to the address of the fulfillment house, shipping and mailing service, or similar location. The manufacturer or distributor is responsible for all recordkeeping requirements and for production of such records as required by sections 499.0121 and 499.028, F.S., this rule and Fl. Admin. Code R. 61N-1.012
2. File with the department a completed application for a permit using an original Form DH 1033, “”Application for Permit Under chapter 499, F.S.,”” effective August 2004.
3. Submit a copy of the applicant’s license or permit which authorizes the possession of prescription drugs. If the issuing agency does not allow photocopying of a license or permit, the applicant may submit a verification of the license or permit from the issuing agency.
4. Pay the appropriate fee(s) as required by Fl. Admin. Code R. 61N-1.018
5. Comply with all the requirements for permitting provided in chapter 499, F.S., and this rule chapter.
(b) Application requirements for Restricted Rx Drug Distributor – Health Care Entity include:
1. Contact the department’s Drugs, Devices, and Cosmetics Program to request an application or download the application from the department’s website.
2. File with the department a completed application for a permit using an original Form DH 1033, “”Application for Permit Under chapter 499, F.S.,”” effective August 2004.
3. Submit a listing of all the locations under common control that will be receiving distributions under this permit. This listing must include the name and address of the facility and the pharmacy or other permit number which authorizes that location to possess prescription drugs. Additional locations must be communicated to the department in writing prior to the transfer of prescription drugs. Alternatively, depending on the basis for the application, provide a copy of the written contract evidencing the group purchasing organization and a listing of all the locations that will be receiving distributions under this permit because of joint membership in the group purchasing organization.
4. Comply with all the requirements for permitting provided in chapter 499, F.S., and this rule chapter.
5. Pay the appropriate fee(s) as required by Fl. Admin. Code R. 61N-1.018
(c) Application requirements for Restricted Rx Drug Distributor – Charitable Organization include:
1. Contact the department’s Drugs, Devices, and Cosmetics Program to request an application or download the application from the department’s website.
2. File with the department a completed application for a permit using an original Form DH 1033, “”Application for Permit Under chapter 499, F.S.,”” effective August 2004.
3. Submit proof of the charitable organization designation under section 501(c)(3) of the Internal Revenue Code.
4. If the FDA has initiated the enrollment program, submit the FDA central file number of the applicant.
5. Comply with all the requirements for permitting provided in chapter 499, F.S., and this rule chapter.
6. Pay the appropriate fee(s) as required by Fl. Admin. Code R. 61N-1.018
(d) Application requirements for Restricted Rx Drug Distributor – Reverse Distributor or Restricted Rx Drug Distributor – Destruction include:
1. Contact the department’s Drugs, Devices, and Cosmetics Program to request an application or download the application from the department’s website.
2. File with the department a completed application for a permit using an original Form DH 1033, “”Application for Permit Under chapter 499, F.S.,”” effective August 2004.
3. Comply with all the requirements for permitting provided in chapter 499, F.S., and this rule chapter.
4. Pay the appropriate fee(s) as required by Fl. Admin. Code R. 61N-1.018
(e) Application requirements for Restricted Rx Drug Distributor – Government Programs include:
1. Contact the department’s Drugs, Devices, and Cosmetics Program to request an application or download the application from the department’s website.
2. File with the department a completed application for a permit using an original Form DH 1033, “”Application for Permit Under chapter 499, F.S.,”” effective August 2004.
3. Submit a detailed plan justifying the necessity for this permit in accordance with subsection 61N-1.023(5), F.A.C.
4. Submit a list of the intended contractors and subcontractors that will receive the entity’s prescription drugs under this permit and the permit numbers that authorize them to administer or dispense. Also submit a copy of the provisions of the contract that address the requirements in section 499.012(1)(a)1.d., F.S.
5. Comply with all the requirements for permitting provided in chapter 499, F.S., and this rule chapter.
6. Pay the appropriate fee(s) as required by Fl. Admin. Code R. 61N-1.018
(f) Application requirements for a Restricted Rx Drug Distributor – Institutional Research include:
1. Contact the department’s Drugs, Devices, and Cosmetics Program to request an application or download the application from the department’s website.
2. File with the department a completed application for a permit using an original Form DH 1033, “”Application for Permit Under chapter 499, F.S.,”” effective August 2004.
3. Comply with all the requirements for permitting provided in chapter 499, F.S., and this rule chapter.
4. Pay the appropriate fee(s) as required by Fl. Admin. Code R. 61N-1.018
(g) Application requirements for a Veterinary Legend Drug Retailer include:
1. Contact the department’s Drugs, Devices, and Cosmetics Program to request an application or download the application from the department’s website.
2. File with the department a completed application for a permit using an original Form DH 1033, “”Application for Permit Under chapter 499, F.S.,”” effective August 2004.
3. Pay the appropriate fee(s) as required by Fl. Admin. Code R. 61N-1.018
4. Comply with all the requirements for permitting provided in chapter 499, F.S., and this rule chapter.
(h) Application requirements for a Medical Oxygen Retailer include:
1. Contact the department’s Drugs, Devices, and Cosmetics Program to request an application or download the application from the department’s website.
2. File with the department a completed application for a permit using an original Form DH 1033, “”Application for Permit Under chapter 499, F.S.,”” effective August 2004.
3. Pay the appropriate fee(s) as required by Fl. Admin. Code R. 61N-1.018
4. Comply with all the requirements for permitting provided in chapter 499, F.S., and these rules.
5. Have an FDA establishment registration number if the establishment will be transfilling medical oxygen.
(9) Designated Representative.
(a) For purposes of the work experience required to be certified as a designated representative:
1. Serving in a managerial capacity does not require actual supervisory responsibilities over employees, but requires a level of responsibility consistent with a managerial employee, including but not limited to decision-making authority, responsibility for developing and implementing policies and procedures related to purchasing, sales, or inventory management for prescription drugs.
2. Responsibilities related to recordkeeping for prescription drugs by a person who worked in a pharmacy may include such activities as, practicing pharmacy pursuant to a valid pharmacy license, routinely purchasing or ordering prescription drugs where cognitive functions were involved and the order is not the result of an automated reorder system, routinely receiving prescription drugs and verifying the accuracy of the order, routinely taking a physical inventory of prescription drugs, routinely assessing the pharmacy shelves for outdated prescription drugs, and routinely completing an inventory for the transfer of adulterated prescription drugs for appropriate disposal.
(b) Application requirements for Certification as a Designated Representative include:
1. Contact the department’s Drugs, Devices, and Cosmetics Program to request an application and fingerprint cards or download the application from the program’s web site.
2. File with the department a completed application for certification using Form DH 2126 “”Application for Certification as a Designated Representative,”” effective June 2005, which is incorporated by reference herein. An application is not deemed completed until the applicant has received a passing score on the laws and rules examination required by section 499.012(16)(b)4., F.S. The applicant will be notified by regular mail at the applicant’s home mailing address of the applicant’s eligibility to schedule the laws and rules examination. Information on scheduling and other testing processes are included on the program’s website in a document entitled “”Candidate’s Information Booklet.”” If the applicant has not passed the laws and rules examination within six months of this notification, the department will initiate action to deny the Application for Certification as a Designated Representative. This six-month period for an applicant to pass the laws and rules examination does not extend the statutory requirement in section 499.012(16)(f), F.S., for a Prescription Drug Wholesaler Distributor or an out-of-state Prescription Drug Wholesaler Distributor to employ a designated representative.
3. Submit a legible fingerprint card and $47.00 per fingerprint card. The fingerprint card must have been obtained from the department so that the card will have the proper coding for processing and reporting.
4. Pay the appropriate fee(s) as required by Fl. Admin. Code R. 61N-1.018
5. Comply with all requirements for certification provided in chapter 499, F.S., and these rules.
(10) Permit renewals for all permits other than a prescription drug wholesaler, prescription drug wholesaler – broker only, or out-of-state prescription drug wholesaler. Submission of a renewal application represents to the department that conditions have not changed with the permitted person which would make the permitted person ineligible to renew the permit.
(a) A permit renewed during the grace period will expire 24 months after the last day of the anniversary month in which the previous permit expired.
(b) An applicant applying to renew a permit which has not expired, been revoked, suspended or otherwise terminated must:
1. File with the department a completed application for a permit using an “”Application for Permit Renewal Under chapter 499, F.S.,”” Form DH 1034, effective January 2004, which is incorporated by reference herein. The permittee should contact the department if the renewal application has not been received at least 30 days prior to the permit’s expiration date.
2. Pay the appropriate fee pursuant to this section and Fl. Admin. Code R. 61N-1.018
3. Comply with all the requirements for permitting provided in chapter 499, F.S., and this rule chapter.
4. Applicants renewing a Retail Pharmacy Wholesaler’s permit must also submit a legible photocopy of the current community pharmacy permit.
(c) If a permit is not renewed prior to the expiration date or within the grace period, the person will be placed out-of-business for purposes of chapter 499, F.S. In order to be permitted after the expiration of the 60-day grace period, a person must submit a new application and proceed according to the requirements for submission of a new application.
(11) Permit renewals for prescription drug wholesaler, prescription drug wholesaler – broker only, or out-of-state prescription drug wholesaler.
(a) The program will mail an application for renewal of the prescription drug wholesaler, prescription drug wholesaler – broker only, or out-of-state prescription drug wholesaler permit at least 90 days prior to the expiration date of the permit.
(b) A renewal application that is postmarked within 45 days prior to the expiration date of the permit must include submission of a $100 delinquent fee in addition to the annual permit fee, fingerprint fees, and bond.
(c) File with the department a completed application for a permit using an original Form DH 2124, “”Prescription Drug Wholesaler/Out-of-State Prescription Drug Wholesaler Application”” effective January 2004.
(d) File with the department an original Form DH 2125, “”Personal Information Statement”” effective January 2004, for the applicant’s manager, next four highest ranking employees that are responsible for prescription drug operations, and all affiliated parties.
(e) Submit a legible fingerprint card for any person for whom a Personal Information Statement is submitted who has not previously submitted a fingerprint card on behalf of the applicant company. These fingerprint cards must have been obtained from the department so that the cards will have the proper coding for processing and reporting.
(f) Submit $47.00 for each fingerprint card submitted.
(g) Submit a $100,000 bond or security as specified in sections 499.012(2)(a) and (c), F.S., and paragraph (7)(b), above. If you are using a surety bond, the required bond form is DH 2128, “”Surety Bond Form,”” effective June 2005.
(h) If the applicant is located outside of Florida, submit a photocopy of the resident state’s current 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:
1. 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
2. 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) which is incorporated by reference herein, for the sale and physical distribution of prescription drugs into Florida.
(i) Pay the appropriate fee(s) as required by Fl. Admin. Code R. 61N-1.018
(j) Comply with all the requirements for permitting provided in chapter 499, F.S., and this rule chapter.
Rulemaking Authority 499.01, 499.012, 499.0121(1), 499.0122, 499.013, 499.014, 499.028, 499.04, 499.041, 499.05, 499.62, 499.63, 499.64, 499.66, 499.67, 499.701 FS. Law Implemented 499.01, 499.012, 499.0121, 499.0122, 499.013, 499.028(6), 499.04, 499.004, 499.041, 499.05, 499.06, 499.006, 499.007, 499.052, 499.062, 499.063, 499.064, 499.066, 499.067 FS. History-New 12-12-82, Amended 7-8-84, 1-30-85, Formerly 10D-45.54, Amended 11-26-86, 2-4-93, 7-1-96, Formerly 10D-45.054, Amended 1-26-99, 4-17-01, 10-29-02, 7-6-03, 1-1-04, 9-13-04, 10-3-05, 1-19-06, Formerly 64F-12.015.
Terms Used In Florida Regulations 61N-1.015
- Attachment: A procedure by which a person's property is seized to pay judgments levied by the court.
- Contract: A legal written agreement that becomes binding when signed.
- Evidence: Information presented in testimony or in documents that is used to persuade the fact finder (judge or jury) to decide the case for one side or the other.
- Grace period: The number of days you'll have to pay your bill for purchases in full without triggering a finance charge. Source: Federal Reserve
(2) A permit is valid only for the name and address to which it is issued. The name in which a permit is issued will be changed, at no cost, upon notification to the department.
(a) The name in which the permit is issued must be the name in which the company is doing business, i.e., the name that appears on purchase and sales invoices.
(b) A permit that authorizes the purchase of prescription drugs will not be issued in a name identical to the name used by any other establishment or licensed permit holder at that address authorized to purchase prescription drugs pursuant to chapter 465, F.S., or the statutes regulating a practitioner authorized to purchase prescription drugs except:
1. A Restricted Rx Drug Distributor – Charitable Organization permit will be issued in the name of the charitable organization or health care entity, and
2. A Medical Oxygen Retailer permit may be issued in the name of a nursing home’s Class I Institutional Pharmacy permit.
(c) A person must be available for inspection at the permitted address during the business hours identified on the application form, holidays excluded. Permanent changes to these business hours must be communicated to the department in writing. At a minimum, these business hours must meet the following standards:
1. For an establishment applying for a permit or permitted as a prescription drug wholesaler or prescription drug wholesaler – broker only, the establishment must designate a minimum of 20 hours weekly between the hours of 8:00 a.m. and 5:00 p.m. (EST), Monday through Friday, and at least one day of the week provide for four consecutive hours.
2. For an establishment applying for a permit or permitted only as a medical oxygen retailer and which does not transfill medical oxygen containers at the permitted establishment, the establishment must designate a minimum of four (4) hours weekly between the hours of 8:00 a.m. and 5:00 p.m. (EST), Monday through Friday, and at least one day of the week provide for two consecutive hours. Furthermore if less than 10 hours weekly are designated, a medical oxygen retailer must be available by telephone between the hours of 8:00 a.m. to 5:00 p.m., Monday through Friday, to schedule an appointment within 24 hours of the department’s telephone call for an inspection during non-designated business hours.
3. Other applicants and permitted establishments must designate a minimum of 10 hours weekly between the hours of 8:00 a.m. and 5:00 p.m. (EST), Monday through Friday, and at least one day of the week provide for two consecutive hours. These standards set forth minimum business hours and agents of the Department of Business and Professional Regulation and the Department of Law Enforcement may inspect, monitor, and investigate during other hours as authorized by law.
(3) On-site Inspections. Passing an on-site inspection is a prerequisite to issuance of a new permit for the following permit types: Prescription Drug Manufacturer, Device Manufacturer, Compressed Medical Gases Manufacturer, Over-the-Counter Drug Manufacturer, Cosmetic Manufacturer, Prescription Drug Wholesaler, Compressed Medical Gases Wholesaler, Freight Forwarder, Veterinary Prescription Drug Wholesaler located in Florida, Veterinary Legend Drug Retailer, Medical Oxygen Retailer, and Restricted Rx Drug Distributor permits for the Health Care Entity, Reverse Distributor, and Destruction facilities. However, the department may elect to perform an inspection of the Restricted Rx Drug Distributor – Charitable Organization, Government Program, or Institutional Research as a condition of permitting but an on-site inspection fee will not be assessed.
(a)1. A person permitted as a Prescription Drug Manufacturer that is applying for additional manufacturing permits, a Complimentary Drug Distributor permit, or a Prescription Drug Wholesaler permit at that address does not require another on-site inspection and is not required to pay an initial application/on-site inspection fee when applying for the additional permits.
2. A person permitted as an Over-the-Counter Drug Manufacturer that is applying for a Device Manufacturer permit or Cosmetic Manufacturer permit at that address does not require another on-site inspection and is not required to pay an initial application/on-site inspection fee when applying for the additional permit.
3. A person permitted as a Cosmetic Manufacturer or Device Manufacturer that is applying for a Device Manufacturing permit or Cosmetic Manufacturing permit does not require another on-site inspection and is not required to pay an initial application/on-site inspection fee when applying for the additional permit.
(b) A person permitted as a Compressed Medical Gases Manufacturer that is applying for either a Compressed Medical Gases Wholesaler permit or a Medical Oxygen Retailer permit at that address does not require another on-site inspection and is not required to pay an initial application/on-site inspection fee when applying for the additional permit.
(c) A person permitted as a Medical Oxygen Retailer that is applying for a Compressed Medical Gases Wholesaler permit at that address does not require another on-site inspection and is not required to pay the initial application/on-site inspection fee when applying for the additional permit. A person permitted as a Medical Oxygen Retailer that has the establishment registered with the FDA for transfilling activity which is applying for a Compressed Medical Gases Manufacturer’s permit at that address does not require another on-site inspection and is not required to pay the initial application/on-site inspection fee when applying for the additional permit.
(d) The department will request from the applicant written documentation to evidence compliance with the requirements of chapter 499, F.S., when an on-site inspection cannot be completed within 30 days of receipt of a completed application for a permit requiring an on-site inspection or a written request for a change of address.
(4) Written policies and procedures as required by chapter 499, F.S., and this rule chapter must be established prior to approval of a permit application. A prescription drug wholesaler that uses a system to digitally sign and electronically authenticate an electronic pedigree must have policies and procedures to protect the security over the digital signatures.
(5) Notification to the department regarding the change of address of a permitted establishment must be in writing. A Change of Address form is available on the department’s web site. Notification regarding the closing of a permitted establishment shall also include the name and address of a person to contact for up to two years after the closing of the business for access to required records.
(6) Manufacturer Permits.
(a) A prescription drug manufacturer’s permit, over-the-counter drug manufacturer’s permit, or device manufacturer’s permit is not required for the manufacture of products that are in an FDA approved investigational program and that are not manufactured for clinical investigation (for actual use in or on humans or animals).
(b) A device manufacturer’s permit is required for an establishment that refurbishes medical devices for subsequent sale but is not required when the refurbishing is performed as a service for the owner of the medical device and the device is returned to the owner for further use.
(c) Application requirements for manufacturers and precription drug repackagers located in Florida include:
1. Contact the department’s Drugs, Devices, and Cosmetics Program to request an application or download the application from the department’s website.
2. File with the department a completed application for a permit using an original Form DH 1033, “”Application for Permit Under chapter 499, F.S.,”” effective August 2004, which is incorporated by reference herein.
3. Pay the appropriate fee(s) as required by Fl. Admin. Code R. 61N-1.018
4. Comply with all the requirements for permitting provided in chapter 499, F.S., and this rule chapter.
5. Have an FDA establishment registration number, or unless the application is for a cosmetic manufacturer, provide documentation to the department supporting an exemption from FDA registration.
(d) Application requirements for Non-resident prescription drug (Rx) manufacturers.
1. A person may qualify as a Non-resident Rx drug manufacturer if
a. The establishment is not located in Florida; and
b.(I) The person and establishment physically manufacture a prescription drug either for itself or as a contract manufacturer; or
(II) The person is the holder of an approved New Drug Application (NDA), Abbreviated New Drug Application (ANDA), or New Animal Drug Application (NADA); or
(III) The person and establishment is a private label distributor and the private label distributor’s prescription drugs are originally manufactured and labeled for the distributor and have not been repackaged; or
(IV) The establishment is the distribution point for the manufacturer, contract manufacturer or private label distributor whether the establishment is a member of the manufacturer’s affiliated group or is a contract distribution site; or
(V) The person and establishment import prescription drugs, including active pharmaceutical ingredients also referred to as bulk ingredients that are lawful in interstate commerce.
2. A non-resident Rx drug manufacturer that also distributes prescription drugs that it did not manufacture (as meeting one of the criteria above) will also need to apply for an out-of-state prescription drug wholesaler permit and meet all of the requirements for obtaining that permit.
3. Contact the department’s Drugs, Devices, and Cosmetics Program to request an application or download the application from the department’s website.
4. File with the department a completed application for a permit using an original Form DH 1033, “”Application for Permit Under chapter 499, F.S.,”” effective August 2004.
5. Submit a photocopy of all permits or licenses issued to the applicant’s address which authorize the manufacture or possession of prescription drugs at that address, regardless of the issuing agency. If the issuing agency prohibits photocopying the permit or license, the applicant may submit a state verification of any permits or licenses issued to the applicant’s address.
6. If the non-resident Rx drug manufacturer is importing prescription drugs, FDA approval can be documented with:
a. An NDA number for the product; or
b. Evidence of an FDA establishment number for the manufacturing site and inclusion of the particular product on the manufacturer’s drug listing with the FDA; or
c. For an active pharmaceutical ingredient, evidence that the manufacturer’s bulk drug substance is identified as an ingredient in an FDA approved finished product; or
d. Other direct evidence of FDA authorization for the importation and commercial distribution of the product.
Updates to the list of prescription drugs being imported and documentation of FDA approval must be submitted to the department prior to importation of any prescription drug under the non-resident Rx drug manufacturer’s permit. It is the non-resident manufacturer’s responsibility to assure that it is only importing approved prescription drugs into Florida and is complying with Florida Statutes § 499.023 Compliance with submission of the information required in this rule does not mean that the prescription drug does in fact comply with all provisions of the Federal Act and chapter 499, F.S., and may be imported.
7. Pay the appropriate fee(s) as required by Fl. Admin. Code R. 61N-1.018
8. Comply with all the requirements for permitting provided in chapter 499, F.S., and this rule chapter.
(7) Wholesaler Permits.
(a) A person applying for or renewing a permit as a prescription drug wholesaler, or as a veterinary prescription drug wholesaler located in Florida, must have an area for the storage of prescription drugs under controlled room temperature and refrigeration, as required by Fl. Admin. Code R. 61N-1.013(3)(d), whether or not the person intends to wholesale prescription drugs requiring storage under controlled room temperature conditions or refrigeration; except that a person who will act as a broker only of prescription drugs may apply for a “”broker only”” designation on the Prescription Drug Wholesaler permit and then the requirement that the permitted address provide for “”controlled room temperature”” and refrigeration is waived. A “”broker only”” cannot take possession of prescription drugs under any circumstances.
(b) The Prescription Drug Wholesaler’s bond and the bond for an out-of-state prescription drug wholesaler will be transferred by the department to subsequent permits issued pursuant to renewal applications if the bond or other equivalent means of security is in a form that will allow for such transfer. The bond will be refunded without interest, consistent with the provisions of Florida Statutes § 499.012(2) In order for another means of security to satisfy the bond requirement, the security must be in a form that the applicant or permittee cannot revoke, withdraw, cancel, or otherwise reduce the department’s interest until the conditions upon which the bond can be refunded or released, as set forth in Florida Statutes § 499.012(2), have been satisfied. If the bond or other security is in a form that requires the department to initiate release of the bond or security, a prescription drug wholesaler or out-of-state prescription drug wholesaler should request in writing that the department release the bond or security within 45 days of satisfaction of the conditions in sections 499.012(2)(a) and (c), F.S., that release department’s interest in the bond or other security. The department must initiate release of the bond or security within 10 working days of satisfaction of the conditions in sections 499.012(2)(a) and (c), F.S., unless the department has otherwise made a claim against the bond or security.
(c) A Prescription Drug Wholesaler is authorized to wholesale all prescription drugs, including compressed medical gases and therefore does not require dual permits.
(d) Application requirements for Compressed Medical Gases Wholesalers include:
1. Contact the department’s Drugs, Devices, and Cosmetics Program to request an application or download the application from the department’s website.
2. File with the department a completed application for a permit using an original Form DH 1033, “”Application for Permit Under chapter 499, F.S.,”” effective August 2004.
3. Pay the appropriate fee(s) as required by Fl. Admin. Code R. 61N-1.018
4. Comply with all the requirements for permitting provided in chapter 499, F.S., and this rule chapter.
(e) Application requirements for Prescription Drug Wholesalers, Prescription Drug Wholesalers – Broker Only, or Out-of-State Prescription Drug Wholesalers include:
1. Contact the department’s Drugs, Devices, and Cosmetics Program for an application form(s) and fingerprint cards. Both the sales transaction (seller) and the physical movement (location from which the drugs are shipped) of prescription drugs are considered wholesale distribution. Therefore, if the seller (name and address as reflected on the invoice) is not the same as the location from which the drugs are shipped (name and address), such as in the case of brokers, different branches of the same company, or a contract warehouse, then both persons (the seller and location from which shipped) must be permitted under the Florida Drug and Cosmetic Act.
2. File with the department a completed application for a permit using an original Form DH 2124, “”Prescription Drug Wholesaler/Out-of-State Prescription Drug Wholesaler Application”” effective January 2004, which is incorporated by reference herein.
3. File with the department an original Form DH 2125, “”Personal Information Statement”” effective January 2004, which is incorporated by reference herein for the applicant’s manager, next four highest ranking employees that are responsible for prescription drug operations, and all affiliated parties.
4. Submit a legible fingerprint card and $47.00 per fingerprint card for each person required to submit a fingerprint card. These fingerprint cards must have been obtained from the department so that the cards will have the proper coding for processing and reporting.
5. Submit a $100,000 bond or security as specified in sections 499.012(2)(a) and (c), F.S., and paragraph (b), above. If you are using a surety bond, the required bond form is DH 2128, “”Surety Bond Form,”” effective June 2005, which is incorporated by reference herein.
6. If the applicant is located outside of Florida, 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:
a. 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
b. 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) which is incorporated by reference herein, for the sale and physical distribution of prescription drugs into Florida.
7. Identify a person who has been Certified pursuant to Florida Statutes § 499.012(11), to serve as the certified designated representative. If the prescription drug wholesaler operates in ‘shift’ schedules, a different person per shift may be designated; however the shift hours for which each person is responsible must be clearly identified. You must use Notification of Designated Representative Form DH 2130, effective June 2005, which is incorporated by reference herein, for communicating changes in the designated representative.
8. Pay the appropriate fee(s) as required by Fl. Admin. Code R. 61N-1.018
9. Comply with all the requirements for permitting provided in chapter 499, F.S., and this rule chapter.
(f) Application requirements for Retail Pharmacy Wholesalers include:
1. Contact the department’s Drugs, Devices, and Cosmetics Program to request an application or download the application from the department’s website.
2. File with the department a completed application for a permit using an original Form DH 1033, “”Application for Permit Under chapter 499, F.S.,”” effective August 2004.
3. Submit a photocopy of all permits issued to the applicant’s address which authorize the purchase of prescription drugs at that address, regardless of the issuing agency.
4. Pay the appropriate fee(s) as required by Fl. Admin. Code R. 61N-1.018
5. Comply with all the requirements for permitting provided in chapter 499, F.S., and this rule chapter.
(g) Application requirements for freight forwarders.
1. Contact the department’s Drugs, Devices, and Cosmetics Program to request an application or download the application from the department’s website.
2. File with the department a completed application for a permit using an original Form DH 1033, “”Application for Permit Under chapter 499, F.S.,”” effective August 2004.
3. Pay the appropriate fee(s) as required by Fl. Admin. Code R. 61N-1.018
4. Comply with all the requirements for permitting provided in chapter 499, F.S., and this rule chapter.
(h) Application requirements for Veterinary Prescription Drug Wholesalers include:
1. Contact the department’s Drugs, Devices, and Cosmetics Program to request an application or download the application from the department’s website.
2. File with the department a completed application for a permit using an original Form DH 1033, “”Application for Permit Under chapter 499, F.S.,”” effective August 2004, and the attachment for the Veterinary Prescription Drug Wholesaler permit, August 2004.
3. Pay the appropriate fee(s) as required by Fl. Admin. Code R. 61N-1.018
4. Comply with all the requirements for permitting provided in chapter 499, F.S., and this rule chapter.
(8) Other Distributors. Persons conducting certain distributions of prescription drugs which are not considered wholesale distributions in the state of Florida must obtain a permit from the department prior to initiating that activity. These permits include Complimentary Drug Distributors, all of the designated Restricted Rx Drug Distributor permits as further discussed in Fl. Admin. Code R. 61N-1.023, Medical Oxygen Retailers, and Veterinary Legend Drug Retailers.
(a) Application requirements for Complimentary Drug Distributors include:
1. Contact the department’s Drugs, Devices, and Cosmetics Program for an application form or download the application from the department’s website. An out of the state manufacturer or distributor of complimentary or sample prescription drugs may obtain a “”Complimentary Drug Distributor permit”” for its headquarters or home office in lieu of a permit for each establishment from which complimentary prescription drugs are distributed. A manufacturer or distributor that uses a fulfillment house, shipping and mailing service, or distributes through co-marketing agreements, must notify the department in writing of the contractor’s name, address, and responsibilities prior to the distribution of prescription drug samples in or into this state. The headquarters or home office location is responsible for all recordkeeping requirements and for production of such records as required by sections 499.0121 and 499.028, F.S., this rule and Fl. Admin. Code R. 61N-1.012 A person located within the state that manufactures or distributes complimentary or sample prescription drugs directly or through its agents, employees, or independent contractors, must obtain a Complimentary Drug Distributor permit for each establishment located in Florida. A manufacturer or distributor that uses a fulfillment house, shipping and mailing service, or distributes through co-marketing agreements, any of which is located in Florida, must obtain a permit in the name of the manufacturer or distributor issued to the address of the fulfillment house, shipping and mailing service, or similar location. The manufacturer or distributor is responsible for all recordkeeping requirements and for production of such records as required by sections 499.0121 and 499.028, F.S., this rule and Fl. Admin. Code R. 61N-1.012
2. File with the department a completed application for a permit using an original Form DH 1033, “”Application for Permit Under chapter 499, F.S.,”” effective August 2004.
3. Submit a copy of the applicant’s license or permit which authorizes the possession of prescription drugs. If the issuing agency does not allow photocopying of a license or permit, the applicant may submit a verification of the license or permit from the issuing agency.
4. Pay the appropriate fee(s) as required by Fl. Admin. Code R. 61N-1.018
5. Comply with all the requirements for permitting provided in chapter 499, F.S., and this rule chapter.
(b) Application requirements for Restricted Rx Drug Distributor – Health Care Entity include:
1. Contact the department’s Drugs, Devices, and Cosmetics Program to request an application or download the application from the department’s website.
2. File with the department a completed application for a permit using an original Form DH 1033, “”Application for Permit Under chapter 499, F.S.,”” effective August 2004.
3. Submit a listing of all the locations under common control that will be receiving distributions under this permit. This listing must include the name and address of the facility and the pharmacy or other permit number which authorizes that location to possess prescription drugs. Additional locations must be communicated to the department in writing prior to the transfer of prescription drugs. Alternatively, depending on the basis for the application, provide a copy of the written contract evidencing the group purchasing organization and a listing of all the locations that will be receiving distributions under this permit because of joint membership in the group purchasing organization.
4. Comply with all the requirements for permitting provided in chapter 499, F.S., and this rule chapter.
5. Pay the appropriate fee(s) as required by Fl. Admin. Code R. 61N-1.018
(c) Application requirements for Restricted Rx Drug Distributor – Charitable Organization include:
1. Contact the department’s Drugs, Devices, and Cosmetics Program to request an application or download the application from the department’s website.
2. File with the department a completed application for a permit using an original Form DH 1033, “”Application for Permit Under chapter 499, F.S.,”” effective August 2004.
3. Submit proof of the charitable organization designation under section 501(c)(3) of the Internal Revenue Code.
4. If the FDA has initiated the enrollment program, submit the FDA central file number of the applicant.
5. Comply with all the requirements for permitting provided in chapter 499, F.S., and this rule chapter.
6. Pay the appropriate fee(s) as required by Fl. Admin. Code R. 61N-1.018
(d) Application requirements for Restricted Rx Drug Distributor – Reverse Distributor or Restricted Rx Drug Distributor – Destruction include:
1. Contact the department’s Drugs, Devices, and Cosmetics Program to request an application or download the application from the department’s website.
2. File with the department a completed application for a permit using an original Form DH 1033, “”Application for Permit Under chapter 499, F.S.,”” effective August 2004.
3. Comply with all the requirements for permitting provided in chapter 499, F.S., and this rule chapter.
4. Pay the appropriate fee(s) as required by Fl. Admin. Code R. 61N-1.018
(e) Application requirements for Restricted Rx Drug Distributor – Government Programs include:
1. Contact the department’s Drugs, Devices, and Cosmetics Program to request an application or download the application from the department’s website.
2. File with the department a completed application for a permit using an original Form DH 1033, “”Application for Permit Under chapter 499, F.S.,”” effective August 2004.
3. Submit a detailed plan justifying the necessity for this permit in accordance with subsection 61N-1.023(5), F.A.C.
4. Submit a list of the intended contractors and subcontractors that will receive the entity’s prescription drugs under this permit and the permit numbers that authorize them to administer or dispense. Also submit a copy of the provisions of the contract that address the requirements in section 499.012(1)(a)1.d., F.S.
5. Comply with all the requirements for permitting provided in chapter 499, F.S., and this rule chapter.
6. Pay the appropriate fee(s) as required by Fl. Admin. Code R. 61N-1.018
(f) Application requirements for a Restricted Rx Drug Distributor – Institutional Research include:
1. Contact the department’s Drugs, Devices, and Cosmetics Program to request an application or download the application from the department’s website.
2. File with the department a completed application for a permit using an original Form DH 1033, “”Application for Permit Under chapter 499, F.S.,”” effective August 2004.
3. Comply with all the requirements for permitting provided in chapter 499, F.S., and this rule chapter.
4. Pay the appropriate fee(s) as required by Fl. Admin. Code R. 61N-1.018
(g) Application requirements for a Veterinary Legend Drug Retailer include:
1. Contact the department’s Drugs, Devices, and Cosmetics Program to request an application or download the application from the department’s website.
2. File with the department a completed application for a permit using an original Form DH 1033, “”Application for Permit Under chapter 499, F.S.,”” effective August 2004.
3. Pay the appropriate fee(s) as required by Fl. Admin. Code R. 61N-1.018
4. Comply with all the requirements for permitting provided in chapter 499, F.S., and this rule chapter.
(h) Application requirements for a Medical Oxygen Retailer include:
1. Contact the department’s Drugs, Devices, and Cosmetics Program to request an application or download the application from the department’s website.
2. File with the department a completed application for a permit using an original Form DH 1033, “”Application for Permit Under chapter 499, F.S.,”” effective August 2004.
3. Pay the appropriate fee(s) as required by Fl. Admin. Code R. 61N-1.018
4. Comply with all the requirements for permitting provided in chapter 499, F.S., and these rules.
5. Have an FDA establishment registration number if the establishment will be transfilling medical oxygen.
(9) Designated Representative.
(a) For purposes of the work experience required to be certified as a designated representative:
1. Serving in a managerial capacity does not require actual supervisory responsibilities over employees, but requires a level of responsibility consistent with a managerial employee, including but not limited to decision-making authority, responsibility for developing and implementing policies and procedures related to purchasing, sales, or inventory management for prescription drugs.
2. Responsibilities related to recordkeeping for prescription drugs by a person who worked in a pharmacy may include such activities as, practicing pharmacy pursuant to a valid pharmacy license, routinely purchasing or ordering prescription drugs where cognitive functions were involved and the order is not the result of an automated reorder system, routinely receiving prescription drugs and verifying the accuracy of the order, routinely taking a physical inventory of prescription drugs, routinely assessing the pharmacy shelves for outdated prescription drugs, and routinely completing an inventory for the transfer of adulterated prescription drugs for appropriate disposal.
(b) Application requirements for Certification as a Designated Representative include:
1. Contact the department’s Drugs, Devices, and Cosmetics Program to request an application and fingerprint cards or download the application from the program’s web site.
2. File with the department a completed application for certification using Form DH 2126 “”Application for Certification as a Designated Representative,”” effective June 2005, which is incorporated by reference herein. An application is not deemed completed until the applicant has received a passing score on the laws and rules examination required by section 499.012(16)(b)4., F.S. The applicant will be notified by regular mail at the applicant’s home mailing address of the applicant’s eligibility to schedule the laws and rules examination. Information on scheduling and other testing processes are included on the program’s website in a document entitled “”Candidate’s Information Booklet.”” If the applicant has not passed the laws and rules examination within six months of this notification, the department will initiate action to deny the Application for Certification as a Designated Representative. This six-month period for an applicant to pass the laws and rules examination does not extend the statutory requirement in section 499.012(16)(f), F.S., for a Prescription Drug Wholesaler Distributor or an out-of-state Prescription Drug Wholesaler Distributor to employ a designated representative.
3. Submit a legible fingerprint card and $47.00 per fingerprint card. The fingerprint card must have been obtained from the department so that the card will have the proper coding for processing and reporting.
4. Pay the appropriate fee(s) as required by Fl. Admin. Code R. 61N-1.018
5. Comply with all requirements for certification provided in chapter 499, F.S., and these rules.
(10) Permit renewals for all permits other than a prescription drug wholesaler, prescription drug wholesaler – broker only, or out-of-state prescription drug wholesaler. Submission of a renewal application represents to the department that conditions have not changed with the permitted person which would make the permitted person ineligible to renew the permit.
(a) A permit renewed during the grace period will expire 24 months after the last day of the anniversary month in which the previous permit expired.
(b) An applicant applying to renew a permit which has not expired, been revoked, suspended or otherwise terminated must:
1. File with the department a completed application for a permit using an “”Application for Permit Renewal Under chapter 499, F.S.,”” Form DH 1034, effective January 2004, which is incorporated by reference herein. The permittee should contact the department if the renewal application has not been received at least 30 days prior to the permit’s expiration date.
2. Pay the appropriate fee pursuant to this section and Fl. Admin. Code R. 61N-1.018
3. Comply with all the requirements for permitting provided in chapter 499, F.S., and this rule chapter.
4. Applicants renewing a Retail Pharmacy Wholesaler’s permit must also submit a legible photocopy of the current community pharmacy permit.
(c) If a permit is not renewed prior to the expiration date or within the grace period, the person will be placed out-of-business for purposes of chapter 499, F.S. In order to be permitted after the expiration of the 60-day grace period, a person must submit a new application and proceed according to the requirements for submission of a new application.
(11) Permit renewals for prescription drug wholesaler, prescription drug wholesaler – broker only, or out-of-state prescription drug wholesaler.
(a) The program will mail an application for renewal of the prescription drug wholesaler, prescription drug wholesaler – broker only, or out-of-state prescription drug wholesaler permit at least 90 days prior to the expiration date of the permit.
(b) A renewal application that is postmarked within 45 days prior to the expiration date of the permit must include submission of a $100 delinquent fee in addition to the annual permit fee, fingerprint fees, and bond.
(c) File with the department a completed application for a permit using an original Form DH 2124, “”Prescription Drug Wholesaler/Out-of-State Prescription Drug Wholesaler Application”” effective January 2004.
(d) File with the department an original Form DH 2125, “”Personal Information Statement”” effective January 2004, for the applicant’s manager, next four highest ranking employees that are responsible for prescription drug operations, and all affiliated parties.
(e) Submit a legible fingerprint card for any person for whom a Personal Information Statement is submitted who has not previously submitted a fingerprint card on behalf of the applicant company. These fingerprint cards must have been obtained from the department so that the cards will have the proper coding for processing and reporting.
(f) Submit $47.00 for each fingerprint card submitted.
(g) Submit a $100,000 bond or security as specified in sections 499.012(2)(a) and (c), F.S., and paragraph (7)(b), above. If you are using a surety bond, the required bond form is DH 2128, “”Surety Bond Form,”” effective June 2005.
(h) If the applicant is located outside of Florida, submit a photocopy of the resident state’s current 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:
1. 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
2. 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) which is incorporated by reference herein, for the sale and physical distribution of prescription drugs into Florida.
(i) Pay the appropriate fee(s) as required by Fl. Admin. Code R. 61N-1.018
(j) Comply with all the requirements for permitting provided in chapter 499, F.S., and this rule chapter.
Rulemaking Authority 499.01, 499.012, 499.0121(1), 499.0122, 499.013, 499.014, 499.028, 499.04, 499.041, 499.05, 499.62, 499.63, 499.64, 499.66, 499.67, 499.701 FS. Law Implemented 499.01, 499.012, 499.0121, 499.0122, 499.013, 499.028(6), 499.04, 499.004, 499.041, 499.05, 499.06, 499.006, 499.007, 499.052, 499.062, 499.063, 499.064, 499.066, 499.067 FS. History-New 12-12-82, Amended 7-8-84, 1-30-85, Formerly 10D-45.54, Amended 11-26-86, 2-4-93, 7-1-96, Formerly 10D-45.054, Amended 1-26-99, 4-17-01, 10-29-02, 7-6-03, 1-1-04, 9-13-04, 10-3-05, 1-19-06, Formerly 64F-12.015.