Click on the appropriate tab below to see the Initial Licensing Requirements, Process, Fees, Statutes and Administrative Rules for a Special Pharmacy Permit.
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 465.016, F.S. and Rule 64B16-28.800, F.A.C.:
- Florida Statutes require a completed application and fees before your application can be reviewed.
- Chapter 465, F.S., requires Special Pharmacies to be under the professional supervision of the PDM or 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 eight (8) types of Special Pharmacy Permit applicants. Please read the descriptions below.
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.
Special Pharmacy Permit Application Information
Check which permit type you are applying for on the application.
- Special- Limited Community Pharmacy Permit are only available to Institutional Class II permittees as an additional permit to allow the facility to provide medications to employees, medical staff and up to a three-day supply of medication to patients being discharged under certain conditions.
- Special- Parenteral and Enteral Pharmacy Permits provide parenteral (IV), enteral, and cytotoxic pharmacy services to outpatients. The applicant must be compliant with the Standard for Compounding Sterile Preparations found in Rule 64B16-27.797, F.A.C. The permittee must provide 24-hour telephone accessibility.
- Special- Closed System Pharmacy Permits provide medicinal drugs, utilizing closed delivery systems, to facilities where prescriptions are individually prepared for the ultimate consumer, including nursing homes, jails, Assisted Living Facilities (ALF’s), Intermediate Care Facility/Mentally Retarded (ICF-MR’s) or other custodial care facilities when defined by Agency for Health Care Administration (AHCA) rules. A Special- Closed System Pharmacy may share locations with an establishment that holds a Community Pharmacy Permit, however record keeping and inventory for each permittee must be maintained separately and distinct.
- Special- Non-Resident Registration is required for those pharmacies located outside the state and ships, mails, or delivers a dispensed medicinal drug into this state. You must submit the Non-Resident Pharmacy permit application, found in the Licensing section of this site, in order to deliver a dispensed medicinal drug in any manner into this state.
- Special- End Stage Renal Dialysis (ESRD) Pharmacy provides dialysis products and supplies to persons with chronic kidney failure and requires the services of a Consultant Pharmacist.
- Special- Parenteral/Enteral Extended Scope is required to compound patient specific enteral/parenteral preparations in conjunction with institutional pharmacy permits, provided requirements set forth herein are satisfied.
- Special- Assisted Living Facility (ALF) is an optional permit for those ALF’s providing a drug delivery system utilizing medicinal drugs provided in unit dose packaging.
Special- Parenteral and Enteral, and Special- Parenteral/Enteral Extended Scope Pharmacy Applicants must complete and submit answers to the policy and procedure questions beginning on page 3 of the application. 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 questions, where applicable, by using excerpts or summaries from the policy and procedure manual.
If applying for a Special Parenteral/Enteral Extended Scope Permit, there are additional questions which must be answered page 5 of the application.
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
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:
- 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.
- 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.
- 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.
- 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.
- Has obtained a permit by misrepresentation or fraud.
- Has attempted to procure, or has procured, a permit for any other person by making, or causing to be made, any false representation.
- 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.
- 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.
- Is currently listed on the United States Department of Health and Human Services Office of Inspector General’s List of Excluded Individuals and Entities.
- 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.
Click on Chapter or Section Number to View
Chapter 456: Health Professions and Occupations: General Provisions
Chapter 465: Pharmacy
Section 465.0196: Special pharmacy permits.
Section 465.022: Pharmacies; general requirements; fees.
Section 465.0181: Community pharmacy permit required to dispense Schedule II or Schedule III controlled substances.
Florida Administrative Codes
Rule 64B16-28.800: Special Pharmacies.
Rule 64B16-28: General Requirements- Permits