Sterile Compounding Permit


Click on the appropriate tab below to see the Initial Licensing Requirements, Process, Fees, Statutes and Administrative Rules for a Sterile Compounding Permit.

The requirements are as follows and can be found in Rule 64B16-28.802, F.A.C.:

  1. A special sterile compounding permit is a type of special permit, which is required before any permitted pharmacy may engage in the preparation of compounding sterile products. The compounding of sterile products must be in strict compliance with the standards set forth in Rules 64B16-27.797 and 64B16-27.700, F.A.C.
  2. 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.

All permitees, with the exception of stand alone Special Parenteral/Enteral and Special Parenteral/Enteral Extended Scope, that are currently compounding sterile products are required to submit this application and will be issued a new Special Sterile Compounding permit number (in addition to your usual pharmacy permit).

This permit is not required for those that hold an individual Special Parenteral & Enteral Pharmacy permit or a Special Parenteral & Enteral Extended Scope permit.

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.

Background Screening

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 Service Providers

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:

(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 General’s 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.

For New Establishments Only

This application must be submitted in addition to the application for primary pharmacy licensure.

Applicants must complete and submit answers to the policy and procedure questions beginning on page 4 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.

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.


For Existing Permitees Only

Applicants must complete and submit answers to the policy and procedure questions beginning on page 4 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.

Once the application is deemed complete, the board staff will issue the new license number.

For New Establishments

New establishments are required to submit $255.00 with the application for the primary pharmacy permit and $255.00 with the application for the Special Sterile Compounding Pharmacy permit 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.

For Existing Permitees

There will be no fee required for existing licensees at this time. Applications submitted after March 21, 2014 will require a fee of $255.00.

Click on Chapter or Section Number to View

Florida Statutes

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 64B16-27.797: Standards of Practice for Compounding Sterile Preparations (CSPs)
Rule 64B16-27.700: Definition of Compounding
Rule 64B16-28: General Requirements – Permits
Rule 64B16-28.100(8): Pharmacy Permits- Applications and Permitting
Rule 65B16-28.802: Special Sterile Compounding Permits