Nonresident Sterile Compounding Application


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

To access a copy of the PDF application for NONRESIDENT STERILE COMPOUNDING PERMIT APPLICATION FOR NON-RESIDENT PHARMACIES please click http://floridaspharmacy.gov/Applications/app-non-resident-sterile.pdf.

To access a copy of the PDF application for NONRESIDENT STERILE COMPOUNDING PERMIT APPLICATION FOR OUTSOURCING FACILITIES please click http://floridaspharmacy.gov/Applications/app-outsourcing-facilties-only.pdf.

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 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.

Health Care Fraud; Disqualification for License, 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:

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:
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;
For the felonies of the third degree, more than 10 years from the date of the plea, sentence and completion of any subsequent probation;
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;
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;
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;
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;
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.

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.

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.

Click on Chapter or Section Number to View

Florida Statutes

Chapter 456: Health Professions and Occupations: General Provisions
Chapter 465: Pharmacy
Chapter 465.0158: Nonresident sterile compounding permit

Florida Administrative Code

Rule: 64B16-28.840: Non Resident (Mail Service)
Rule: 64B16-28.100: Pharmacy Permits- Applications and Permitting