Whether opening a new establishment, changing locations, or changing owners, a pharmacy permit is required prior to operating in the State of Florida.
The requirements are as follows and can be found in Section 465.019, F.S.:
- Florida Statutes require a completed application and fees before your application can be reviewed.
- Chapter 465, F.S., requires all institutional pharmacies to be under the professional supervision of the consultant pharmacist of record licensed in the State of Florida. A Florida licensed pharmacist shall perform compounding and dispensing of medicinal drugs.
Attestation for Business Taxable Assets
If the applicant has more than $100 million dollars of business taxable assets in this state, please submit a formal opinion letter from a Certified Public Accountant duly licensed in the state of your principal place of business affirming the corporation has more than $100 million of business taxable assets in this state for the previous tax year. In lieu of submitting a formal opinion letter from a Certified Public Accountant, the applicant may submit its Florida Corporate Income/Franchise and Emergency Excise Tax Return (Form F-1120, Effective 01/09).
Articles of Organization
All applicants for pharmacy permit must submit a Certificate of Good Standing or Articles of Organization issued by the Department of State Division of Corporations.
There are three types of Institutional Pharmacy Permit applicants. Please read the description below. Check which permit type you are applying for on the application.
Submit fingerprint results. Please review the Background Screening information provided below.
Applicants with Discipline History
If you answer “yes” to any of the disciplinary history questions on the application, Please provide a certified copy of document(s) relative to any disciplinary action taken against any license. The documents must come from the agency that took the disciplinary action and must be certified by that agency.
In addition, include detailed description of the circumstances surrounding your disciplinary action and a thorough description of the rehabilitative changes in your lifestyle since the time of the disciplinary action which would enable you to avoid future occurrences. It would be helpful to include factors in your life, which you feel may have contributed to your disciplinary action, what you have learned about yourself since that time, and the changes you have made that support your rehabilitation.
The Board of Pharmacy has created guidelines for specific actions to be cleared in the board office; however, the staff cannot make determinations in advance as laws and rules do change over time.
Applicants with Criminal History
The Board of Pharmacy has created guidelines for specific offenses to be cleared in the board office; however, the staff cannot make determinations in advance as laws and rules do change over time. Violent crimes and repeat offenders are required to be presented to the Board of Pharmacy for review. Evidence of rehabilitation is important to the Board when making licensure decisions.
Applicants with prior criminal convictions are required to submit the following documentation to the Board:
Final Dispositions/Arrest Records – Final disposition records for offenses can be obtained at the clerk of the court in the arresting jurisdiction. If the records are not available, you must have a letter on court letterhead sent from the Clerk of the Court attesting to their unavailability.
Completion of Probation/Parole/Sanctions – Probation and financial sanction records for offenses can be obtained at the clerk of the court in the arresting jurisdiction. Parole records for offenses can be obtained from the Department of Corrections or at the clerk of the court in the arresting jurisdiction. If the records are not available, you must have a letter on court letterhead sent from the clerk of the court attesting to their unavailability.
Self Explanation – Applicants who have listed offenses on the application must submit a letter in their own words describing the circumstances of the offense.
Failure to submit fingerprints will delay your application. All owners, officers and prescription department managers are required to submit a set of fingerprints unless the corporation is exempt under the Section 465.022, Florida Statutes for corporations having more than $100 million of business taxable assets in this state. These corporations are only required to have the prescription department manager or consultant of record to submit fingerprints. The statute allows the prescription department manager for a corporation having more than $100 million of business taxable assets in this state to submit results from AHCA if the results were also available to the Department and are within one year of the receipt date of the application. If the manager prints were submitted to DOH within one year of the date of the application they are not required to submit them over.
The Department of Health accepts electronic fingerprinting service offered by Livescan device vendors approved by the Florida Department of Law Enforcement and listed on their site. Livescan Provider List
You must provide accurate demographic information at the time your fingerprints are taken, including your Social Security number. The Department will not be able to process a submission that does not include your Social Security number.
You must provide the correct ORI number. The ORI number for the pharmacy profession is EDOH4680Z
Institutional Pharmacy Permit Application Information
There are three types of Institutional Pharmacy Permit applicants. Please read the description below and check which permit type you are applying for on the application.
- Institutional Class I Pharmacy – An Institutional Class I pharmacy is an institutional pharmacy in which all medicinal drugs are administered from individual prescription containers to the individual patient and in which medicinal drugs are not dispensed on the premises. No medicinal drugs may be dispensed in a Class I Institutional pharmacy. A Special- Closed System Pharmacy Permit, Special Parenteral and Enteral Pharmacy Permit, or Community Pharmacy Permit provide the individual patient prescriptions.
- Institutional Class II Pharmacy Permit – An Institutional Class II pharmacy is an institutional pharmacy that employs the services of a registered pharmacist or pharmacists who, in practicing institutional pharmacy, provide dispensing and consulting services on the premises to patients of that institution, for use on the premises of that institution. An Institutional Class II pharmacy is required be open sufficient hours to meet the needs of the hospital facility.The consultant pharmacist of record shall be responsible for establishing written policy and procedure manual for the implementation of the general requirements set forth in Rule 64B16-28.702, F.A.C. An Institutional Class II Pharmacy may elect to participate in the Cancer Drug Donation Program. If you are applying for this permit and would like to participate, please answer “yes” on question 20 of the application and attach a Notice of Participation to your application. For more information about the Cancer Drug Donation Program, and for a copy of the Notice of Participation, please visit the Cancer Drug Donation Program website.
- Modified Institutional Class II Pharmacy Permits – Modified Institutional Class II pharmacies are those institutional pharmacies in short-term, primary care treatment centers that meet all the requirements for a Class II permit, except space and equipment requirements. Modified Class II Institutional pharmacies are designated as Type “A”, Type “B” and Type “C” according to the type of specialized pharmaceutical delivery system utilized. Please review Rule 64B16-28.702, Florida Administrative Code for specific requirements.Institutional Class II Pharmacy Permit Applicants and Modified Institutional Class II Pharmacy Applicants complete and submit with application answers to the applicable questions found in the application instructions.The Consultant Pharmacist of Record is responsible for developing and maintaining a current policy and procedure manual. The permittee must make available the policy and procedure manual to the appropriate state or federal agencies upon inspection. Do not send the policy and procedure manual to the board office. The board office will approve the policy and procedure manual based upon answers submitted for the following questions, where applicable, by using excerpts or summaries from the policy and procedure manual.
- Class III Institutional Pharmacy Permits-A Class III Institutional Pharmacy permit is required prior to performing any of the activities enumerated in section 465.019(2)(d)1., F.S., including operating a central distribution facility and preparing prepackaged drug products and performing other pharmaceutical services for entities under common control. A Class III Institutional Pharmacy must be affiliated with a hospital. A Class III Institutional Pharmacy permit may be issued to entities already holding other permits from the Board, including Class II and Modified Class II Institutional pharmacy permits. The three classes of entities which may be issued Class III Institutional Pharmacy Permits are:
Institutional Pharmacies that provide the same services as authorized for Class II Institutional Pharmacies. Institutional Class II Pharmacies employ the services of a registered pharmacist or pharmacists who, in practicing institutional pharmacy, provide dispensing and consulting services on the premises to patients of that Institution, for use on the premises of that institution. An Institutional Class II pharmacy is required be open sufficient hours to meet the needs of the hospital facility. Modified Institutional Class II pharmacies are those institutional pharmacies in short-term, primary care treatment centers that meet all the requirements for a Class II permit, except space and equipment requirements.
Currently permitted Class II or Modified Class II Institutional Pharmacies. Pharmacies currently permitted as Class II or Modified Class II Institutional Pharmacies may apply for a Class III Institutional Pharmacy permit. If issued a Class III Institutional Pharmacy permit, these existing permittees may continue to hold both a Class II/Modified Class II Institutional Pharmacy Permit and a Class III Institutional Pharmacy Permit.
Change of Association for existing Permittees is an alternative to issuance of a new Class III Institutional Pharmacy permit. An entity holding an active Class II or Modified Class II Institutional Pharmacy permit may have that permit re-associated as a Class III Institutional Permit by completing form DOH/MQN PH20 “Change of Permit Association – Class III Pharmacy,”. Re-association extinguishes the Class II / Modified Class II permit, and the existing permit number is re-associated to a Class III. Please see Rule 64816-28.750, F.A.C. and Form DOH/MAQ/PH20 for more information.
Central Distribution Facilities are facilities under common control with a hospital that has been issued a Class III Institutional Pharmacy permit. Central Distribution Facilities dispense, distribute, compound, and fill prescriptions; prepare prepackaged drug products for entities under common control with the hospital and the Central Distribution Facility; and conduct other pharmaceutical services for entities under common control.
Health Care Fraud; Disqualification for License, Certificate, or Registration
IMPORTANT NOTICE: The department or board shall deny an application for a pharmacy permit if the applicant or an affiliated person, partner, officer, director, or prescription department manager or consultant pharmacist of record of the applicant:
(a) Has been convicted of, or entered a plea of guilty or nolo contendere to, regardless of adjudication, a felony under Chapter 409, Chapter 817, or Chapter 893, Florida Statutes (F.S.), or a similar felony offense committed in another state or jurisdiction, since July 1, 2009.
(b) Has been convicted of, or entered a plea of guilty or nolo contendere to, regardless of adjudication, a felony under 21 U.S.C. ss. 801-970 or 42 U.S.C. ss. 1395-1396 since July 1, 2009.
(c) Has been terminated for cause from the Florida Medicaid program pursuant to s. 409.913, F.S., unless the applicant has been in good standing with the Florida Medicaid program for the most recent 5-year period.
(d) Has been terminated for cause, pursuant to the appeals procedures established by the state, from any other state Medicaid program, unless the applicant has been in good standing with a state Medicaid program for the most recent 5-year period and the termination occurred at least 20 years before the date of the application.
(e) Has obtained a permit by misrepresentation or fraud.
(f) Has attempted to procure, or has procured, a permit for any other person by making, or causing to be made, any false representation.
(g) Has been convicted of, or entered a plea of guilty or nolo contendere to, regardless of adjudication, a crime in any jurisdiction which relates to the practice of, or the ability to practice, the profession of pharmacy.
(h) Has been convicted of, or entered a plea of guilty or nolo contenedre to, regardless of adjudication, a crime in any jurisdiction which relates to health care fraud.
(i) Is currently listed on the United States Department of Health and Human Services Office of Inspector Generalâs List of Excluded Individuals and Entities.
(j) Has dispensed any medicinal drug based upon a communication that purports to be a prescription as defined by s. 465.003(14) or s. 893.02, F.S., when the pharmacist knows or has reason to believe that the purported prescription is not based upon a valid practitioner-patient relationship that includes a documented patient evaluation, including history and a physical examination adequate to establish the diagnosis for which any drug is prescribed and any other requirement established by board rule under Chapter 458, Chapter 459, Chapter 461, Chapter 463, Chapter 464, or Chapter 466, F.S.
If applicable, please provide documentation to the Florida Board of Pharmacy.
Once the application is deemed complete, the board staff authorizes an inspection. Upon completion of the inspection, the inspector notifies the board office as to whether the inspection was satisfactory or unsatisfactory. If the inspection is satisfactory, a permit number is issued within 7 days. Please wait 7-14 days from your satisfactory inspection before checking on the status of your permit. You may lookup your license number on our website.
Drug Enforcement Administration (DEA)
The DEA will not issue a registration until the Florida Board of Pharmacy has issued a pharmacy permit.
If controlled substances will be involved in your pharmacy practice, you must make an Application for Registration under the Controlled Substance Act of 1970 with the DEA. If possible, you are encouraged to use the on-line form system provided by the DEA. Information is available by visiting their website. DEA Form 224 may be obtained in paper form by writing to:
Drug Enforcement Administration
Attn: ODR PO Box 2639
Springfield, VA 22152-2639
Mail completed DEA Form 224 via U.S. Postal service to the address listed on the form.
Contact the Drug Enforcement Administration (DEA) at 1-800-667-9752 or 954-306-4654 for information regarding change of location or change of name.
The actual copy of your license should arrive within 7 days of the issue date.
Certified check or money order should be made payable to the Florida Department of Health
Application fee: $255.00
Fee includes non-refundable $250.00 application fee and $5.00 unlicensed activity fee.
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Florida Administrative Code
Rules: Chapter 64B16-28: Permits