Nonresident Sterile Compounding Permits

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Nonresident Sterile Compounding Permits

Applying for a License

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

Florida passed House Bill 975 following the 2024 legislative session, which requires this profession to complete electronic fingerprinting. Your application cannot be approved until this requirement, along with all other licensure criteria, has been met. For more information on background screening, visit MQA's Background Screening website.

Requirements
General Requirements for Non-Resident Sterile Compounding Application

To access a copy of the PDF application for Nonresident Sterile Compounding Permit Application For Nonresident Pharmacies please click here.

To access a copy of the PDF application for Nonresident Sterile Compounding Permit Application For Outsourcing Facilities please click here.

An applicant must submit the following to the board to obtain an initial permit, or to the department to renew a permit:

(a) Proof of registration as an outsourcing facility with the Secretary of the United States Department of Health and Human Services if the applicant is eligible for such registration pursuant to the federal Drug Quality and Security Act, Pub. L. No. 113-54.

(b) Proof of registration as a nonresident pharmacy, pursuant to s. 465.0156, unless the applicant is an outsourcing facility and not a pharmacy, in which case the application must include proof of an active and unencumbered license, permit, or registration issued by the state, territory, or district in which the outsourcing facility is physically located which allows the outsourcing facility to engage in compounding and to ship, mail, deliver, or dispense a compounded sterile product into this state.

The requirements are as follows and can be found in Chapter 465.0158, Florida Statutes:

1. In order to ship, mail, deliver, or dispense, in any manner, a compounded sterile product into this state, a nonresident pharmacy registered under s. 465.0156, or an outsourcing facility, must hold a nonresident sterile compounding permit.

2. An applicant must submit the following to the board to obtain an initial permit, or to the department to renew a permit:

(a) Proof of registration as an outsourcing facility with the Secretary of the United States Department of Health and Human Services if the applicant is eligible for such registration pursuant to the federal Drug Quality and Security Act, Pub. L. No. 113-54.

(b) Proof of registration as a nonresident pharmacy, pursuant to s. 465.0156, unless the applicant is an outsourcing facility and not a pharmacy, in which case the application must include proof of an active and unencumbered license, permit, or registration issued by the state, territory, or district in which the outsourcing facility is physically located which allows the outsourcing facility to engage in compounding and to ship, mail, deliver, or dispense a compounded sterile product into this state.

(c)Written attestation by an owner or officer of the applicant, and by the applicant’s prescription department manager or pharmacist in charge, that:

1. The attestor has read and understands the laws and rules governing sterile compounding in this state.

2. The attestor has read and understands the laws and rules governing sterile compounding in this state.

3. A compounded sterile product shipped, mailed, delivered, or dispensed into this state must not have been, and may not be, compounded in violation of the laws and rules of the state, territory, or district in which the applicant is located.

(d) The applicant’s existing policies and procedures for sterile compounding, which must comply with pharmaceutical standards in chapter 797 of the United States Pharmacopoeia and any standards for sterile compounding required by board rule or current good manufacturing practices for an outsourcing facility.

(e) A current inspection report from an inspection conducted by the regulatory or licensing agency of the state, territory, or district in which the applicant is located. The inspection report must reflect compliance with this section. An inspection report is current if the inspection was conducted within 6 months before the date of submitting the application for the initial permit or within 1 year before the date of submitting an application for permit renewal.

Applicants with Health History

If a “Yes” response was provided to any of the questions in this section, provide the following documents directly to the board office:

A letter from a licensed health care practitioner, who is qualified by skill and training to address the condition identified, which explains the impact the condition may have on the ability to practice the profession with reasonable skill and safety. The letter must specify that the applicant is safe to practice the profession without restrictions or specifically indicate the restrictions that are necessary. Documentation provided must be dated within one year of the application date.

A written self-explanation, identifying the medical condition(s) or occurrence(s); and current status.

Applicants with Discipline History

Applicants with prior disciplinary actions are required to submit the following:

Board Actions – Certified copies of document(s), i.e. Final Order and Administrative Complaint, 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.

Self-Explanation – A 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.

Applicants with Criminal History

Applicants with prior criminal convictions are required to submit the following:

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. Include in your letter the date of the original offense, the charge, and the jurisdiction where it occurred.

To review the conviction record guidelines adopted by the Board, click here.

Health Care Fraud, Disqualification of Licensure, Certificate, or Registration

Effective July 1, 2012, Section 456.0635, Florida Statutes (F.S.), provides that health care boards or the department shall refuse to issue a license, certificate or registration and shall refuse to admit a candidate for examination if the applicant:

  1. Has been convicted of, or entered a plea of guilty or nolo contendere to, regardless of adjudication, a felony under Chapter 409, F.S., (relating to social and economic assistance), Chapter 817, F.S., (relating to fraudulent practices), Chapter 893, F.S., (relating to drug abuse prevention and control) or a similar felony offense(s) in another state or jurisdiction unless the candidate or applicant has successfully completed a drug court program for that felony and provides proof that the plea has been withdrawn or the charges have been dismissed. Any such conviction or plea shall exclude the applicant or candidate from licensure, examination, certification, or registration, unless the sentence and any subsequent period of probation for such conviction or plea ended:
    1. For the felonies of the first or second degree, more than 15 years from the date of the plea, sentence and completion of any subsequent probation;
    2. For the felonies of the third degree, more than 10 years from the date of the plea, sentence and completion of any subsequent probation;
    3. For the felonies of the third degree under section 893.13(6)(a), F.S., more than five years from the date of the plea, sentence and completion of any subsequent probation;
  2. 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 (relating to controlled substances) or 42 U.S.C. ss. 1395-1396 (relating to public health, welfare, Medicare and Medicaid issues), unless the sentence and any subsequent period of probation for such conviction or pleas ended more than 15 years prior to the date of the application;
  3. Has been terminated for cause from the Florida Medicaid program pursuant to section 409.913, F.S., unless the candidate or applicant has been in good standing with the Florida Medicaid program for the most recent five years;
  4. Has been terminated for cause, pursuant to the appeals procedures established by the state or Federal Government, from any other state Medicaid program, unless the candidate or applicant has been in good standing with a state Medicaid program for the most recent five years and the termination occurred at least 20 years before the date of the application;
  5. Is currently listed on the United States Department of Health and Human Services Office of Inspector General’s List of Excluded Individuals and Entities. The section above does not apply to candidates or applicants for initial licensure or certification who were enrolled in an educational or training program on or before July 1, 2009, which was recognized by a board or, if there is no board, recognized by the department, and who applied for licensure after July 1, 2012.
Process

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

Applicants will be notified within 7 to 14 days of the receipt of an application and informed of any deficiencies. In cases of deficient applications, applicants will be notified in writing of what is required to complete the application.

Along with their application Nonresident Pharmacies must submit a letter of licensure verification for both the facility and the Pharmacy Manager from their local state, territory or district board of pharmacy. The letter must include the original licensure date, the expiration date; and current licensure status. Nonresident Pharmacies must also submit a copy of their most recent inspection by the state, territory, or district board of pharmacy or the entity responsible for conducting inspections in the state where they are physically located. Inspections must display compliance with USP Chapter .

An inspection report is current if the inspection was conducted within 6 months before the date of submitting the application for the initial permit or within 1 year before the date of submitting an application for permit renewal. If you are unable to submit a current inspection report conducted displaying compliance with USP Chapter due to acceptable circumstances as established by rule, or if no current inspection has been performed, the department shall:

A. Conduct or contract with an entity to conduct, an onsite inspection for which all costs shall be borne by the applicant; or

B. Accept a current and satisfactory inspection report from an entity approved by the board.

Along with their applications Outsourcing Facilities must submit proof of registration as an outsourcing facility with the Secretary of the United States Department of Health and Human Services; and a current inspection report from the United States Food and Drug Administration conducted pursuant to the federal Drug Quality and Security Act, Pub. L. No. 113-54

All pharmacies must answer the policy and procedure questions beginning on Page 2 of the application. The questions will help our inspectors understand more about your pharmacy’s approach to USP Chapter . Please answer the questions as completely and legibly as possible. Attach additional pages if needed.

Applicants must submit their existing policies and procedures for sterile compounding with this application. The policies and procedures must comply with pharmaceutical standards in chapter 797 of the United States Pharmacopoeia and any standards for sterile compounding required by board rule or current good manufacturing practices for an outsourcing facility.

The Prescription Department Manager or Pharmacist in Charge 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.

Fees

All applicants are required to submit $255.00 with the application for the permit and $255.00 with the application for the Nonresident Special Sterile Compounding 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.

Statutes and Rules

Click on Chapter or Section Number to View

Florida Statutes

Chapter 456: Health Professions and Occupations: General Provisions
Chapter 465: Pharmacy

Florida Administrative Code

Rule: 64B16-32: Nonresident Pharmacies

Processing Times

Florida law provides that an initial application must be reviewed within 30 days. Below is the average number of days at which we are currently processing.

Apply Online / Return to Login

To apply online visit MQA Services Portal to create an account or return to your account by clicking the button below.

Renewing Your License

Click on the appropriate tab below to see the Renewal Requirements, Process, Fees and Continuing Education (CE) for a Nonresident Sterile Compounding Permits

Florida passed House Bill 975 following the 2024 legislative session, which requires this profession to complete electronic fingerprinting. Your application cannot be approved until this requirement, along with all other licensure criteria, has been met. For more information on background screening, visit MQA's Background Screening website.

Requirements

Current licenses expire at midnight, Eastern Time, on  February 28, 2025.

Delinquent licenses that expired on  February 28, 2023 become null and void on August 29, 2023.

Failure to renew an active license by the expiration date will result in the license being placed in delinquent status. Failure by a delinquent licensee to renew within six months of the license becoming delinquent renders the license Null & Void without any further action by the board or the Department.

To ensure you receive your renewal notification from the Department, your current mailing address must be on file.

Nonresident Sterile Compounding permit holders are required to submit a current inspection to be included with the renewal application. The inspection must have been conducted within one year before the date of the renewal application.

Board Approved Agencies

Nonresident Sterile Compounding Facilities:

  • Food and Drug Administration (FDA)
  • National Association of Boards of Pharmacy- Verified Pharmacy Program (NABP-VPP)
  • Accreditation Commission for Healthcare (ACHC)
  • Inspection Standard USP797 – Pharmaceutical Compounding-Sterile Preparations

Nonresident Sterile Compounding – Outsourcing Facilities:

  • Food and Drug Administration (FDA)
  • State Inspection Report – Entities must meet cGMP standards
  • Florida Department of Health (DOH)

If you have not been inspected by one of the above agencies, an inspection can be conducted by Florida at your cost. If an inspection must be conducted by the State of Florida, please notify the Board at InspectionSSCP@flhealth.gov

The Department will renew your license upon receipt of a completed renewal application and fees.

Process

Complete your renewal application. This renewal application must be submitted via US Mail.

  1. Submit all required documentation requested in the renewal application including a current inspection report and policies and procedures.
  2. Mail your complete renewal packet and with your cashier’s check or money order to:
    Division of Medical Quality Assurance
    P.O. Box 6320
    Tallahassee, FL 32314-6320

Additional Information:

  • If you are renewing your license after the expiration date and your status still indicates Clear, you will be assessed a delinquency fee. The delinquency fee will be in addition to your renewal fees.
  • The process of renewing a license may take 7-10 business days. Initiating contact to confirm the receipt of fees or the status of your license prior to this time will not expedite the renewal process.
  • A change in location and a change in ownership for a nonresident sterile compounding permit for nonresident pharmacies and a nonresident sterile compounding permit for outsourcing facilities shall require the submission of a new application and the issuance of a new permit.
  • If you wish to update your supervising pharmacist or pharmacist in charge, please submit your request to MQAPharmPDMAffiliate@FLHealth.gov and/or mail to:

Board of Pharmacy
4052 Bald Cypress Way Bin C-04
Tallahassee, FL 32399-3258

Fees

Certified check or money order should be made payable to the Florida Department of Health

Renewing DURING the Renewal Period

Renewal Fee$255.00

Renewing AFTER the Renewal Period
(March 1, 2025 – August 31, 2025)

Delinquent Renewal Fee$355.00

Delinquent licenses go Null & Void1 6 months after the expiration date.

1Null & Void – The establishment operator failed to renew their delinquent license before the end of the renewal cycle.

Statutes and Rules

Click on Chapter or Section Number to View

Florida Statute

Chapter 456: Health Professions and Occupations: General Provisions
Chapter 465: Pharmacy
Section 465.008: Renewal of License
Section 465.022: Pharmacys: general requirements; fees.

Florida Administrative Code

Rule 64B16-26.1022: Permit Fees

Renew Online

To renew online visit the MQA Services Portal by clicking the button below.