Drugs, Devices & Cosmetics FAQs

To obtain an interpretation of statute or rule from an agency requires the submission of a Petition for Declaratory Statement that is authorized by Chapter 120, Florida Statutes and an agency cannot provide an informal legal opinion. The responses to the frequently asked questions are not intended to be legal opinions or statements of agency policy and you are strongly encouraged to seek the guidance of a regulatory consultant to assist you regarding the interpretation and application of Florida Statutes and rules.

Definitions:

  • “DBPR” or the “department” or refers to the Florida Department of Business and Professional Regulation.
  • “DEA” refers to the U.S. Drug Enforcement Administration.
  • “ARCOS” refers to the Automation of Reports and Consolidated Orders System operated by DEA.
  • “CSR” refers to Florida’s state analogue to ARCOS, the Controlled Substance Reporting system.
  • E-FORCSE” refers to Florida’s “Electronic-Florida Online Reporting of Controlled Substances Evaluation”, aka the “Prescription Drug Monitoring Program” or “PDMP”.  For more information visit the E-FORCSE homepage at http://www.floridahealth.gov/reports-and-data/e-forcse/index.html.
  • “FTP” File Transfer Protocol
Does my company need a permit?

DDC permitting requirements as regards drugs, (medical) devices and cosmetics fall into two main categories:(a) manufacturing and repackaging of drugs, medical devices and cosmetics conducted in Florida, and (b) distributing drugs, medical devices and cosmetics in and into Florida.

Activity Description Location Permit (Generally) Required under Chapter 499?
Manufacturing a Drug, Device or Cosmetic In Florida Yes
Repackaging a Drug, Device or Cosmetic In Florida Yes
Distributing a Prescription Drug In or Into Florida Yes
Distributing an Over-the-Counter Drug In or Into Florida No
Distributing a Device In or Into Florida No
Distributing a Cosmetic In or Into Florida No

 

  • What is a “drug”, “device”, or “cosmetic”?

Refer to Section 499.003, Florida Statutes: http://www.leg.state.fl.us/statutes/index.cfm?App_mode=Display_Statute&Search_String=&URL=0400-0499/0499/Sections/0499.003.html Please note that “drug” specifically includes active pharmaceutical ingredient (API). Also, “devices” that contain “drugs” are classified as drugs if any of the principal intended purposes is achieved through chemical action.

  • What is “distributing”?

Understanding this term is critical to avoid violating Chapter 499, Florida Statutes. Florida law defines “distributing” or “distribution” to implicate both physical possession and legal title or ownership. The term means to sell; offer to sell; give away; transfer, whether by passage of title, physical movement, or both; deliver; or offer to deliver. For example, a broker of a prescription drug wholesale transaction may require a permit under Florida law. The term excludes, however, certain administrative activities,

My company distributes medical convenience kits and other “combination products” to customers in Florida. Do we need a permit?

Possibly.  Florida law contains no exemption for “combination products” containing prescription drugs.  As such, medical convenience kits that contain prescription drugs are generally regulated as prescription drugs. For a definition of Combination Products check out: http://www.fda.gov/CombinationProducts/AboutCombinationProducts/ucm118332.htm Unless you are the “manufacturer” of all the prescription drugs contained in the combination product, a (Nonresident) Prescription Drug Manufacturer permit may not provide appropriate licensure under Chapter 499, Florida Statutes.

My company’s administrative office does not handle any prescription drugs. Do we still need to get a permit for that location?

Possibly.  Corporate offices, sales centers, call centers, etc. sometimes engage in activity constituting a sale, or an offer to sell or to deliver.  See the definition of “distributing”, above.

My company is relocating its operation. Do we need to apply for a new permit?
Possibly. A permit issued under Chapter 499, Florida Statutes is only valid for the establishment for which the permit was originally issued. Changing establishments requires a new permit application (probably a change of physical location application)– before the move. An “establishment” is a place of business at one general physical location that may extend to one or more contiguous suites, units, floors, or buildings operated and controlled exclusively by entities under common operation and control. Where multiple buildings are under common exclusive ownership, operation, and control, an intervening thoroughfare does not affect the contiguous nature of the buildings. For purposes of permitting, each suite, unit, floor, or building must be identified in the most recent permit application.
My company is undergoing a change of ownership. Do we need to (re)apply?

Possibly.  Permits issued under Chapter 499, Florida Statutes are specific to the original holder, and may not be bought, sold, traded, leased or otherwise transferred.  Further, an application for a new permit is required when a majority of the ownership or controlling interest of a permitted establishment is transferred or assigned or when a lessee agrees to undertake or provide services to the extent that legal liability for operation of the establishment will rest with the lessee. The application for the new permit must be made before the date of the sale, transfer, assignment, or lease. Please review Rule 61N-1.001(2)(e), F.A.C. Common types of ownership changes:

Transaction Description New Permit (Generally) Required?
Change of ownership of the establishment (often in the form of an asset sale). Yes
Change of ownership of the permittee (often in the form of a stock sale) Yes
Merger or acquisition where permittee DOES NOT survive the transaction Yes
Merger or acquisition where permittee survives the transaction, and controlling interest in the permittee has not changed Usually No
Change of ownership of the permittee’s parent entity Usually No
Change of ownership of the permittee’s “grandparent” entity Almost Never

Rule 61N-1.001(2)(e), F.A.C.:

(e) “Change in Ownership” – means that there has been a transfer or assignment of a majority of the direct ownership or controlling interest of a permitted establishment or that a lessee of a permitted establishment agrees to or becomes legally liable for the operation of the establishment. A transfer or assignment of a majority of direct ownership or controlling interest of a permitted establishment occurs where an event or other transaction occurs and the result of such event or transaction is that more than 50% of the ownership interest or controlling interest of the permitted establishment resides with a person who prior to the event or transaction did not own or control more than a 50% ownership interest in the permitted establishment. A change in the permitted establishment’s federal identification number or the taxpayer identification number is indicative of a change in ownership, but is not dispositive; a change of ownership could occur where the federal identification number or the taxpayer identification number does not change. For a publicly traded corporation, the changing of officers or directors is not a change in ownership nor is the change in ownership of a parent company provided that such change does not result in more than a 50% change in the ownership or controlling interest of any permitted establishment.

My company is a prescription drug wholesale distributor (in-state or out-of-state). Our Certified Designated Representative (CDR) just quit. What do we do?

Notify the department within 10 business days from the CDR’s separation. Your company may continue to distribute prescription drugs in or into Florida during that 10-business day-period. After that period expires, however, your company must either (a) engage a replacement CDR and notify the department of same or (b) cease prescription drug distributions in or into Florida.

My company manufactures and/or distributes active pharmaceutical ingredient (“API”) to customers in Florida. Do we need a permit?

All API’s are “drugs” under Chapter 499, Florida Statutes, and an API is a “prescription drug” if substantially all finished dosage forms in which it may be lawfully dispensed or administered in this state are also prescription drugs. As such, manufacturing or repackaging an API in Florida requires a permit. Distributing an API in or into Florida may require a permit – regardless of where the API is manufactured or by whom.

Are there any exceptions to the licensing requirements under Chapter 499, Florida Statutes?

Here are some exceptions:

  • Intracompany Transfers to Florida-Located Prescription Drug Wholesale Distributor Permittees. An out-of-state prescription drug wholesale distributor permit is not required for an intracompany sale or transfer of a prescription drug from an out-of-state establishment that is duly licensed as a prescription drug wholesale distributor, in its state of residence, to a licensed prescription drug wholesale distributor in this state, if both wholesale distributors conduct wholesale distributions of prescription drugs under the same business name.
  • Research & Development.
    • An unlicensed nonresident manufacturer may distribute (i) a prescription drug active pharmaceutical ingredient (API – not a finished dosage form), (ii) that it manufactures, (iii) to a prescription drug manufacturer permitted in this state, and (iv) in limited quantities intended for research and development and not for resale, or human use other than lawful clinical trials and biostudies authorized and regulated by federal law.

 

    • A permit is not required to distribute limited quantities of a prescription drug that has not been repackaged from an establishment located in the United States to an establishment located in this state permitted as a prescription drug manufacturer for research and development or to a holder of a letter of exemption issued by the department for research, teaching, or testing. The prescription drug distributor must hold a valid prescription drug distribution license under the laws of the state where the transaction originates. The label must label prominently display the following statement: “Caution: Research, Teaching, or Testing Only – Not for Manufacturing, Compounding, or Resale.”
  • API Distributions to Florida Prescription Drug Manufacturers for Production. A permit is not required to distribute an API from an establishment located in the U.S. to an establishment located in this state permitted as a prescription drug manufacturer for use by the recipient in preparing, deriving, processing, producing, or fabricating a prescription drug finished dosage form at the establishment in this state where the product is received under an approved and otherwise valid New Drug Approval Application (NDA), Abbreviated New Drug Application (ANDA), New Animal Drug Application (NADA), or Therapeutic Biologic Application (also “Biologics License Application” or BLA), provided that the application, active pharmaceutical ingredient, or finished dosage form has not been withdrawn or removed from the market in this country for public health reasons. The API distributor must hold a valid prescription drug distribution license under the laws of the state where the transaction originates.
  • Pharmacies and Healthcare Practitioners. Florida-licensed pharmacies operating in compliance with pharmacy practice standards defined in Chapter 465, Florida Statutes and rules adopted under that chapter are not “manufacturers” under Chapter 499, Florida Statutes and are therefore exempt from drug manufacturer permitting requirements. Lawful prescription drug dispensing and administration activities are likewise not “distribution” transactions subject to prescription drug distributor permitting requirements under Chapter 499, Florida Statutes.
Are there any special provisions under Chapter 499, Florida Statutes for research and development?

Yes. as follows:

  • Research & Development (Pre-Clinical).A permit is not required for the manufacture and distribution of products that (i) are the subject of an FDA-approved investigational program,and(ii) are not for clinical research or investigation (for actual use in or on humans or animals). The department recommends ensuring that the products are labeled accordingly to avoid confusion.
  • Research & Development (Clinical).
    • An unlicensed nonresident manufacturer may distribute (i) a prescription drug active pharmaceutical ingredient (API – not a finished dosage form), (ii) that it manufactures, (iii) to a prescription drug manufacturer permitted in this state, and (iv) in limited quantities intended for research and development and not for resale, or human use other than lawful clinical trials and biostudies authorized and regulated by federal law.
    • A permit is not required to distribute limited quantities of a prescription drug that has not been repackaged from an establishment located in the United States to an establishment located in this state permitted as a prescription drug manufacturer for research and development or to a holder of a letter of exemption issued by the department for research, teaching, or testing.The prescription drug distributor must hold a valid prescription drug distribution license under the laws of the state where the transaction originates. The label must label prominently display the following statement: “Caution: Research, Teaching, or Testing Only – Not for Manufacturing, Compounding, or Resale.”
  • Exemption Letters. The department may issue exemption letters to qualified persons who use prescription drugs for lawful research, teaching, or testing, and not for resale.
  • Restricted Prescription Drug Distributor – Institutional Research Permit
Can the department give a variance from or waiver of requirements set forth in Chapter 499, Florida Statutes?

Probably not.  Florida executive agencies such as the department cannot give waivers or variances of statutory requirements.  The department may, however, provide such a variance or waiver with respect to the administrative rules promulgated under Chapter 499, Florida Statutes.

What is a prescription drug pedigree? Does my company have to acquire one or provide one?
What does the Division of Drugs, Devices, and Cosmetics inspection authority cover? Does inspection authority include access to protected health information (subject to HIPAA)? Does inspection authority include photography?

Yes. Please review Ch. 499.051, Florida Statutes.

What if I am discovered to have operated without a permit?

You may be fined, subject to a civil penalty, an injunction, product seizure, referral to the State of Attorney’s office for criminal prosecution and other actions.

Prescription drugs and medical gases already listed with FDA, do I need to do the same at the state level in FL? Who is required to list the RX drugs and medical gases with DBPR? Manufacturers, wholesale distributors, retail distributors?

Yes. All prescription drugs, including medical gases, and over- the- counter drugs, manufactured in Florida must be registered with the Department of Professional Regulation. Manufacturers are required to register/list the prescription drugs, medical gases and over- the- counter drugs with the Department of Business and Professional Regulation.  Please review Ch. 499.015, Florida Statutes.

Are there any exemptions for cosmetic manufacturing?

NO PERMIT IS REQUIRED TO MANUFACTURER CERTAIN COSMETICS PRODUCTS

THE LEGISLATURE IN THE 2021 SESSION AMENDED SECTON 499.01(2)(p), FLORIDA STATUTES (2020) AND CREATED AN EXEMPTION ALLOWING CERTAIN COSMETICS TO BE MANUFACTURED WITHOUT A PERMIT.

A permit to manufacture cosmetic soaps, lotions, moisturizers and creams is NOT required under the following conditions:

  • The person manufacturing the cosmetics has annual gross sales of $25,000 or less;
  • The cosmetic product must be packaged and sold with a label meeting the requirements of the Federal Food and Drug Administration;
  • The cosmetic product is a soap, lotion, moisturizer or cream;
  • The cosmetic is not adulterated and is not misbranded as defined by 21 United States Code sections 361 and 362;
  • The cosmetics are stored on the premises of the cosmetic manufacturing operation; and
  • Each unit of the cosmetic product contains, in contrasting color and in not less than 10-point font, the following statement: “Made by a manufacturer exempt from Florida’s cosmetic manufacturing permit Requirements “

Upon request, an exempt cosmetics manufacturer must provide to the Department written documentation to verify his or her annual gross sales.

The Department of Business and Professional Regulation has authority to inspect the premises as well as investigate any complaint received about these cosmetic products. This exemption does not exempt any person from any state or federal tax law, rule, regulation or certificate, or from any county or municipal law or ordinance that applies to cosmetic manufacturing.

Is a Non-Resident Prescription Drug Manufacturer required to have a Florida Certified Designated Representative?

No, having a Certified Designated Representative is not a requirement for the Non-Resident Prescription Drug Manufacturer permit.

Can I change my physical address online?

Not at this time. Please mail the Change of Physical Location application along with payment made payable to Florida Department of Business and Professional Regulation to 2601 Blair Stone Road, Tallahassee, Florida  32399-1047. You can find this application on the Division’s website.

How do I change my mailing address?

You can submit the application for mailing address change only to the Department of Business and Professional Regulation, 2601 Blair Stone Road, Tallahassee, FL 32399-1047. You can find the application on the Division’s website.

How do I change the name on my permit?

Mail the Change of Name change form to the Department requesting the name change. If the applicant is located outside the state of Florida, also submit a copy of your valid resident state license that authorizes the distribution of prescription drugs from the new address. If the name change is associated with a majority change in ownership, the new owners must apply for a new permit.

When are renewal applications mailed?

Renewal applications for Prescription Drug Wholesale Distributor and Out-of-State Prescription Drug Wholesale Distributors are mailed to the mailing address on file at least 90 days prior to the permit’s expiration date. Renewal applications for all other Chapter 499 permits are mailed at least 90 days prior to the permit’s expiration date.

Although I mailed my renewal application prior to the permit’s expiration date, the renewal application has not been approved. May I continue to operate?
If your application was timely submitted, you may continue to operate in accordance to Chapter 499, F.S. and Rule 61N-1, F.A.C. during the renewal process.
How do I verify if a company is permitted or clear to do business?

Visit www.myfloridalicense.com for the status of a permit. If the permit has expired but the status is Current, please call (850) 717-1800 to determine if the applicant is going through the renewal process and authorized to operate.

I am applying for a Prescription Drug Wholesale Distributor-Broker Only permit. Is my establishment required to have a Certified Designated Representative (CDR) since I won’t physically take possession of prescription drugs?

Yes, having a Certified Designated Representative is one of the minimum requirements for the Prescription Drug Wholesale Distributor – Broker Only permit.

Is an applicant for an Out-Of-State Prescription Drug Wholesale Distributor permit required to have a Florida Certified Designated Representative?

Yes, having a Certified Designated Representative is one of the minimum requirements for the Out-of-State Prescription Drug Wholesale Distributor permit.

How do I schedule the Certified Designated Representative (CDR) exam?

Initially, you must submit the Application for Certification of Designated Representative, Personal Information Statement and $150.00 fee.  If the Drugs, Devices and Cosmetics Program does not have your fingerprint results on file, you must also submit a fingerprint card along with the $47.00 fee.  Prior to scheduling the exam, our office must deem you eligible to sit for the exam and send authorization to our computer based testing vendor. Once you have been deemed eligible to sit for the exam, you may contact Pearson Vue to schedule the exam, 1-888-204-6230.  Once you have schedule the examination, please make sure you arrive to the exam site on time, with two forms of identification.

Where do I locate information regarding scheduling the Certified Designated Representative exam?

The Candidate Information Booklet (CIB) is available at the Department’s website, www.myfloridalicense.com.

Can I bring a friend or family member to the exam site?

Only the applicant will be allowed into the examination room.

I am a licensed pharmacist. Am I exempt from taking the Certified Designated Representative exam?

No; To become a Florida Certified Designated Representative, you must receive a passing score of at least 75 percent on an examination given by the Department regarding state and federal laws and rules governing the distribution of prescription drugs.

If I have been certified as a designated representative in another state, must I also be certified by Florida?

Yes, you must be certified by Florida in order to serve as the designated representative for an establishment licensed by Florida as a Prescription Drug Wholesale Distributor, Prescription Drug Wholesale Distributor-Broker Only, and Out-of-State Prescription Drug Wholesale Distributor.

The Certified Designated Representative for my company is leaving the company, what should I do?

You must employ another certified designated representative and notify the department within 10 business days of the identity of the new designated representative. A wholesale distributor may not operate under a prescription drug wholesale distributor or an out-of-state prescription drug wholesale distributor permit for more than 10 business days after the designated representative leaves the employ of the wholesale distributor unless you employ another certified designated representative and notify the Department within 10 business days of the identity of the new designated representative.

Where can I obtain a copy of your laws and rules?

Visit www.myfloridalicense.com to obtain a copy of Florida laws and rules.

How do I obtain fingerprint cards?

To obtain a fingerprint card, contact our office at (850) 717-1800.

Is electronic fingerprinting available?

Yes, applicants can use any Livescan vendor that has been approved by the Florida Department of Law Enforcement to submit their fingerprints to the department. Please ensure that the Originating Agency Identification (ORI) number is provided to the vendor when you submit your fingerprints.
NOTE: Failure to provide an ORI number or incorrect ORI number to the vendor will prevent DBPR from receiving your fingerprint results.

The applicant is fully responsible for selecting the vendor and ensuring submission of the prints to the department. The Department of Business and Professional Regulation (DBPR) requires the submission of a full set of fingerprints with most licensure applications.

  • To select an approved FDLE Livescan vendor from the link below.  You will need to provide an ORI number to the vendor so they can submit the fingerprints directly to FDLE.  Submit a copy of your receipt with a completed application for licensure.  NOTE: The Livescan vendor will charge you directly for the fingerprint scan.

Vendor contact information can be viewed at: Livescan Device Vendors List

If I have previously submitted fingerprint cards, do I have to submit another card during the renewal process?

No, if the Drugs, Devices, and Cosmetics Program have your fingerprint results on file, you are not required to submit another card.

How often must I submit my Personal Information Statement?

An original Personal Information must be submitted with each application for Prescription Drug Wholesale Distributor, Prescription Drug Wholesale Distributor – Broker Only, and Out-of-State Prescription Drug Wholesale Distributor permit.

Where do I mail my application?

Your completed application should be mailed to the Department of Business and Professional Regulations, Drugs, Devices, and Cosmetics Program, 2601 Blair Stone Road, Tallahassee, FL 32399-1047.

Who do I make the check payable to?

Make all checks payable to Florida Department of Business and Professional Regulation.

Are Chapter 499 permits issued to a residence address?

No; an establishment that is a place of residence may not receive a permit and may not operate under Chapter 499, F.S.

I am not located in Florida, is my establishment required to pass an initial on-site inspection?

Passing and onsite inspection is not a prerequisite to issuance of a permit for an establishment located outside the state of Florida, although the Department may conduct a pre-permit or routine inspection, onsite or otherwise.

If my products are not manufactured, labeled, or repackaged in Florida, may I obtain a Florida Certificate of Free Sale?

No; Certificates of Free Sale are only issued for products manufactured or labeled in Florida, by an establishment licensed by the Drugs, Devices, and Cosmetics Program to manufacture such products.

What is a registered agent and how do I find my registered agent?

A registered agent is responsible for accepting legal and tax documents from the State government on behalf of the company. The registered agent is located on your legal name filing with the Florida Department of State, Division of Corporations.

What does the state of incorporation means?

It means the State your company was incorporated.

What is required for a retail pharmacy drug wholesale distributor?

The establishment has to be located in Florida and licensed as a community pharmacy under Chapter 465, Florida Statutes that purchase prescription drugs at fair market prices and “provide prescription services to the public.”  Provide prescription services to the public means holding the pharmacy out to the public through prominently displayed pharmacy signs on the exterior of the building and adequate inventory on hand to fill a variety of prescriptions for a variety of medical conditions that would be required by the public generally.

Scope of Authorized Wholesale Distribution Activity: Prescription drug wholesale distributions under this permit are subject to the following limitations:  Wholesale distribution activity may not exceed 30 percent of the total annual purchases of prescription drugs. Only the following customers located in Florida: (i) other community pharmacy establishments licensed under Chapter 465, Florida Statutes that purchase prescription drugs at fair market prices and “provide prescription services to the public”; (ii) Modified Class II institutional pharmacies; and (iii) health care practitioners licensed in this state who are authorized by law to dispense or prescribe prescription drugs

What constitutes as a drug claim?

Please review section 499.003(17)(b)(c), Florida Statutes – Statements making claims such as those set forth in section 499.003(17(b)(c), Florida Statutes would be drug claims.

Do I need to get a commercial license; I would rather operate out of my home? I cannot afford a commercial license.

Yes, you are required to obtain the appropriate permit type. You may also be required to obtain local licenses. We do not issue our permits to residential areas.

Can I operate out of a shared kitchen to make cosmetics?

No, you cannot operate out of a shared kitchen.

What are the facility requirements for manufacturing cosmetics?

Please review Rule 61N-1.009, Florida Administrative Code and 21 Code of Federal Regulations.

What is the difference between business records and DSCSA transactional data records?

Please review Ch. 499.0121(6) and 499.89, Florida Statutes and Rule 61N-1.028, Florida Administrative Code for more information regarding this matter.  Business records and DSCSA transactional data records are NOT the same requirements.

What is the security requirements for a prescription drug wholesale distributor - broker only permit?

Please review Ch. 499.0121(2), Florida Statutes and Rule 61N-1.013, Florida Administrative Code for more information regarding this matter.  Security requirements, including an alarm system apply to a broker including security for computerized/electronic records to prevent loss of information and alteration of data.

What is the purpose of the HCCE permit?

The purpose of the Health Care Clinic Establishment permit is to allow an entity at one location that provides health care services at that location to purchase prescriptions drugs in the business name of the entity for use by the practitioner(s) of that location for the patients of that location. Historically physicians have purchased drugs under their own licenses, but they were not allowed to purchase prescription drugs for group practice settings because the drugs would belong to the physician and transferring the drugs to another physician for use on that physician’s patients would be an unlawful wholesale distribution. The HCCE permit was created to facilitate the transfer of prescription drug; the practice, as opposed to one of the physicians, would purchase the drugs for use by the practice. If you only have one physician in the office, but still purchasing prescription drugs in the business entity’s name, the HCCE permit is still required. This permit requires a designated qualifying practitioner who will be responsible for complying with all legal and regulatory requirements related to the purchase, record keeping, storage, and handling of the prescription drugs. The HCCE must employ a qualifying practitioner at each establishment. The qualifying practitioner and HCCE must notify the department within ten (10) days of any subsequent change in the qualifying practitioner. This permit does not replace any permits required by the Florida Agency for Healthcare Administration.

How do I know if I need a HCCE permit?

If you are purchasing prescription drugs under the business name, the HCCE permit is required.

Do I need the HCCE permit if I am the only practitioner who works at the business?

If the practitioner is purchasing the prescription drugs with his own medical license, then an HCCE permit is not required. If the business is the one purchasing the prescription drugs, then the HCCE permit is required.

If I am the only practitioner that works in my business, but at times I have backup practitioners, do I need the HCCE permit?

Yes, if the business is purchasing the prescription drugs where all practitioners can use the prescription drugs, the HCCE permit is required.

If I purchase prescription drugs in my name using my individual practitioner license, can the payment be submitted with my company's check?

If you are purchasing the prescription drugs with the business check, the HCCE permit is required because the business entity is buying the prescription drugs and must be authorized to purchase prescription drugs.

What are the exemptions to the HCCE Permit?

There are no exemptions to the HCCE permit.

Where do I mail my application?

You can mail in applications to our mailing address:

 

Department of Business & Professional Regulation

Division of Drugs, Devices, & Cosmetics

2601 Blair Stone Rd.

Tallahassee, FL 32399-1047

How long is the processing time for an HCCE application?

Processing takes anywhere between 21-30 days. We process applications in the order in which they were received.

Does the law prohibit the use of prescription drugs by practitioners in a group practice where purchased by another member of the group at that establishment?

Yes, the law prohibits practitioner use of prescription drugs that were purchased by another practitioner. The HCCE permit authorizes the business to purchase the prescription drugs to allow all practitioners in the practice to use the drugs.

Is the HCCE permit issued to mobile units?

No, HCCE permits are only issued to one specific location, not mobile units.

If my business is solely a mobile unit, can prescription drugs be purchased in my business name?

No.  Mobile Units do not qualify for a HCCE permit.

Can veterinarians have prescription drugs dropped shipped to the stable/farm/racetrack?

We do allow non-controlled veterinarian only drugs to be drop shipped to a stable farm or a race track if the veterinarian has advised the distributor in writing that the stable farm or race track is the veterinarian’s practice location.

Do animal shelters need the HCCE permit?

If the animal shelter in non-governmental entity and it is purchasing prescription drugs in the business name, then yes a HCCE permit is required.

Who can be considered as a Designated Qualifying Practitioner?

Medical Doctor (M.D.), Osteopathic Physician (D.O.), Physician Assistant (P.A.), Advanced Registered Nurse Practitioner (ARNP), Optometrist (O.D.), Podiatric Physician (D.P.M.), Dentist (D.D.S., D.M.D.), Veterinarian (D.V.M.), Area of Critical Need Doctor (ACN), Limited License Medical Doctor (LLMD), Health Access Dental(HAD); see definition of health care practitioner in section 456.001(4), Florida Statutes as well as section 499.01(2)(r), Florida Statues for the requirements to be a Designated Qualifying Practitioner.

What are the responsibilities of the Designated Qualifying Practitioner (DQP)?

The DQP is responsible for complying with all legal and regulatory requirements related to the purchase, record keeping, storage, and handling of the prescription drugs. The Health Care Clinic Establishment (HCCE) must employ a designated qualifying practitioner at each establishment. The designated qualifying practitioner and HCCE must notify the department within ten (10) days of any subsequent change in the designated qualifying practitioner. See section 499.01(2)(r)1, Florida Statues.

How do I change my Designated Qualifying Practitioner?

There is a form named “Notice of Designated Qualifying Practitioner Change” under our “forms and publications” section on our website.

On the application, do I include my DEA license as additional permits with the state?

The question on page 7 only requests for permits issued by any agency of the State of Florida that authorize the purchase or possession of prescription drugs at the applicant’s establishment or address. The DEA number is not issued by the State of Florida; therefore, it is not required to be provided. DEA Number is recommended to be provided if you have one.

For the applicant's full legal name, should I list the owner's personal name?

The “full legal name” is the complete name of the business entity that will be operating the establishment. This is generally the name that is on the documents that establish the existence or formation of the business entity. For example, a corporation’s full legal name would normally be the name that is found in the corporation’s articles of incorporation.

Can I pay for the application fee over the phone?

We do not accept payment over the phone.

How do I pay the application fee online?

If you submitted the application, but not the payment. You can go to “make an online payment” on your online services main menu and you will see the pending payments.

How do I update my company's name?

There is a name change application that is required and can be found in our “forms and publications” section on our website. No fee is required to change the name.

How can I make revisions to my application submitted online?

After an online application is submitted, no revisions can be made. You will need to contact the processor assigned to the application to make those revisions.

When will the permit be mailed?

You can go online and print a duplicate permit on your online services. If you have not made an account and linked your permit, you can create one and link the permit in order for you to request a printed copy of your permit.

Can I update the address on my application?

If the application has not been approved, you can update the address by emailing your processor with the correction. If the permit has been approved, a change of physical location application is required. If you are only changing your mailing address, you can update that on your online services account.

How do I update my physical location address to my establishment?

A change in physical location application is required with the appropriate fees. You can locate this application on the Division’s website.

Who needs a medical gas wholesaler permit?

Please review sections 499.82(14)(15), Florida Statutes.

What are the expectations for prescriptions when oxygen is delivered to a patient?

Please review Ch. 499.83(2)(c), Florida Statutes.

How do I know what type of permit is needed, Retail/Wholesale/Manufacturer?

Based on the activities you are performing with medical gas.

What business records are required for an audit trail?

Please review sections 499.005(18), 499.0121(4)(c)(6)(a)(b)(c), and 499.89(1) Florida Statutes, and 61N-1.012(1)(2)(4) Florida Administrative Code

Records to document the movement of drugs, devices or cosmetics must provide a complete audit trail from a person’s receipt or acquisition to sale or other disposition of the product or component. A complete audit trail includes records which document each transaction or step in the receipt, manufacture, shipping, transfer, or other steps in the channel of trade of that person, whether or not physical possession or handling of the product or component occurs. At a minimum, records shall consist of invoices from the supplier or source which documents acquisition of each product by the person and invoices of the sale or other transfer by the person to the recipient.

Inbound – inbound documentation (invoice) showing the sale/change of title of the drug (seller and purchaser). Inbound documentation (packing slip, packing list) showing the physical movement of the drug (shipper and recipient). You may receive and maintain only one document for the inbound distribution if that one document shows all of the minimum required elements for the distribution. If your combined business records for the inbound distribution are missing any of the elements listed below, it is your responsibility to contact your vendor to have documents brought into compliance.

Outbound  – outbound documentation (invoice) showing the sale/change of title of the drug (seller and purchaser). Outbound documentation (packing slip, packing list, delivery ticket) showing the physical movement of the drug (shipper and recipient). You may use only one document for the outbound distribution if that one document shows all of the minimum required elements for the distribution. If your combined business records for the outbound distribution are missing any of the elements listed below, your business records are not compliant.

Required Elements

Over-the-counter drugs, medical devices, and cosmetics – required elements include name and address of the seller or transferor of the product; address of the location the product was shipped from; the date of the sale or distribution of the product; name and quantity of the product involved; and name and address of the person who purchased the product.

Prescription drugs (non-medical gas) – required elements include name and address of the seller, and the Florida permit number of the seller if such seller is not exempt from Florida permitting requirements; the address of the location the active pharmaceutical ingredient or prescription drug was shipped from; the distribution date; the name, strength, and quantity, and the National Drug Code if such code has been assigned; the name and Florida permit number of the person that purchased the pharmaceutical ingredient or prescription drug; the financial data, including the unit type and unit price, for the distributions; the date and method of disposition of the active pharmaceutical ingredient or prescription drug; and if delivery of prescription drugs is made to a person other than the purchaser, the name, address or location where the prescription drugs are delivered, and the state license, permit or registration number for that location must be included also.

Medical gas – required elements include the name and address of the seller, and the Florida permit number of the seller if such seller is not exempt from Florida permitting requirements; the address of the location the active pharmaceutical ingredient or prescription drug was shipped from; the dates of receipt and distribution or other disposition of the medical gas; the name, address, and license or permit number and its expiration date for the person or entity purchasing the medical gas from the supplier; the name, address, and license or permit number and its expiration date for the person or entity receiving the medical gas, if different than the purchaser; the name, strength, and quantity, and the National Drug Code if such code has been assigned is preferred; information sufficient to perform a recall of all medical gas received, distributed, or dispensed; the financial data; and in the case of a medical oxygen retailer, a valid, current prescription .

After oxygen is delivered, can the customer just sign the delivery driver’s tablet, or is a hard copy receipt required at the time of delivery?

As the supplier of a prescription drug, you must provide the customer with a business record to document their receipt of the drug. The customer may need this record for a number of reasons. The customer may agree to receive the business record electronically, however it is not realistic to expect that all medical oxygen patients have the ability to receive their business records electronically and the retailer should have resources available to provide the customer their business record(s) at the time of service.

Why is Nitrous Oxide policy required if I only sell Oxygen?

Because your permit authorizes you to sell Nitrous Oxide whether or not you plan on selling Nitrous Oxide.

As a medical gas manufacturer/retail/wholesaler, what is the timeframe to retrieve records via digital or hardcopies whether be within FL or from out-of-state?

Records for permittees located in the state or persons located in Florida and required to be permitted under Chapter 499 Florida Statutes may be stored by computer or other electronic means at a central location inside or outside of the state, but must be readily available and are subject to inspection at the permitted establishment during the inspection.

 If not maintained as a central location, records must be maintained at the permitted location, or at the address reflected on the product registration.

A permitted establishment in Florida that maintains records at a location outside of the state must have a method, such as computerized access, to make records readily available and immediately retrievable.

Records kept at the inspection site or that can be immediately retrieved by computer or other electronic means shall be readily available for authorized inspection during the retention period.  “Readily available” and “readily retrievable” mean that records, either hard copy or computerized, are organized in such a manner that they can be quickly and easily retrieved during an inspection; individual records can be produced within minutes of the request.

Records for permittees not physically located within the state may be maintained at a central location outside of the state but must be made available for inspection at a permitted establishment or at the department’s address within 2 working days after a request for inspection.

As a permitted Florida resident medical gas wholesale distributor, can I distribute outside of Florida? If not, what are the requirements to do so?

The Florida permit does not authorize distribution outside of the State of Florida. You would need to inquire with other states as to the state’s licensing requirements.

As a permitted out-of-state/non-FL-Resident medical gas manufacturer, can I distribute into FL? If not, what are the requirements to do so?

No. You must obtain the appropriate Florida permit.

Do the Division of Drugs, Devices, and Cosmetics permit non-resident medical gas manufacturers?

No.

Can an out-of-state medical gas manufacturer or wholesale distributor distribute (sell and/or ship) medical gas to a purchaser and/or recipient located in Florida?

No. An out-of-state medical gas establishment wishing to distribute (sell and/or ship) medical gas into Florida must hold a Florida nonresident prescription drug manufacture permit, or a Florida medical gas wholesale distributor permit. The correct permit depends on your firm’s activities.

What is “Due Diligence”? Who should exercise it? For a medical gas manufacturer/retail/wholesaler in practice, what does performing due diligence exactly implies and required from me?

Florida Statutes Section 499.88, defines Due diligence.—

(1) A wholesale distributor shall obtain, before the initial acquisition of medical gas, the following information from the supplying wholesale distributor or manufacturer:

(a) If a manufacturer is distributing to a wholesale distributor, evidence that the manufacturer is registered and the medical gas is listed with the United States Food and Drug Administration;

(b) If a wholesale distributor is distributing to a wholesale distributor, evidence that the wholesale distributor supplying the medical gas is legally authorized to distribute medical gas within or into the state;

(c) The name of the responsible facility contact person for the supplying manufacturer or wholesale distributor; and

(d) Certification that the manufacturer’s or wholesale distributor’s policies and procedures comply with this part.

(2) A wholesale distributor is exempt from obtaining the information from a manufacturer, as required under subsection (1), if the manufacturer is registered with the United States Food and Drug Administration in accordance with s. 510 of the federal act and the manufacturer provides:

(a) Proof of such registration; and

(b) Proof of inspection by the United States Food and Drug Administration or other regulatory body within the past 3 years demonstrating substantial compliance with current good manufacturing practices applicable to medical gases.

(3) A manufacturer or wholesale distributor that distributes to or acquires medical gas from another wholesale distributor shall provide to or obtain from the distributing or acquiring manufacturer or distributor the information required by s. 499.89(1), as applicable.

I am already registered/licensed with FDA/DEA, do I need a permit with DBPR to distribute/purchase medical gas in FL?

Yes.

As a medical gas retail distributor, can I “send” some of my inventory to another location whenever needed?

No.

As a medical gas wholesale distributor, can I deliver directly to the patients knowing that the health care establishment is still the entity ordering, being billed, and in charge of the prescriptions?

No.

How much are the fees to register a main product?

The fee is $30 biennially

How much are the fees to register identical products?

The fee is $15 biennially.

How do I obtain a list of our current registered products?

You can request a list of the products from the Division of Drugs, Devices, and Cosmetics by emailing the Division at: DDCQuestions@myfloridalicense.com or calling the Division at 850-717-1800.

How do I get a copy of the application or complete the application online?

You can obtain a copy of the application on our website under the “Apply for license” link or you may create an online account and submit the application online at: https://www.myfloridalicense.com/datamart/loginFLDBPR.do.

What do I need to submit with the application?

You will need a completed application and labels for the products as well the information set forth in Rule 61N-1.016, Florida Administrative Code.

Do I have to apply for a product registration application if I am applying for a prescription drug manufacturer or over-the-counter manufacturer?

If you are located in the State of Florida and are applying for a prescription drug manufacturer or an over-the-counter manufacturer permit, a product registration application is required.

Do I complete the application as an initial permit if I currently have a product registration permit?

Unless there is a change of ownership, then you use the current product registration permit.

Does our company need to register with CSR and submit monthly reports?

Companies that meet both of the following requirements must register with CSR and submit monthly reports of controlled substance distributions:

  1. Distributes or may distribute from time to time any controlled substances in or into Florida; and
  2. Permitted (or required to be permitted) as one of the following:
  • Prescription Drug Wholesale Distributor,
  • Out-of-State Prescription Drug Wholesale Distributor,
  • Retail Pharmacy Drug Wholesale Distributor,
  • Prescription Drug Manufacturer,
  • Nonresident Prescription Drug Manufacturer, or
  • Prescription Drug Repackager
How do we register with CSR?

Review the “Information to Establish a CSR Account” section of the CSR User Guide.

What substances do we have to report?

Florida law requires reporting of all controlled substance distributions, Schedules II through V, inclusive. This differs significantly from DEA’s ARCOS reporting requirements. Florida’s schedules are set forth in Section 893.03, Florida Statutes.

How do we report, and what format do we use?

The report must be electronic and in the same format used for controlled substance reporting to ARCOS.  For more detailed information, review the CSR User Guide.

My company was not aware that we were required to register with CSR and begin reporting. What do we do?

Section 499.0121(14), Florida Statutes does not provide for any grace period. Your company should register with CSR immediately, and submit all required distribution data from July 1, 2011 to the present. The department reserves all rights with respect to CSR noncompliance.

Our company is supposed to be registered with CSR and submitting reports. What happens if we do not comply?

Failure to comply with CSR requirements could result in (i) denial, refusal to renew, revocation, or suspension of any permit or certification issued to the offender under the Florida Drug and Cosmetic Act; (ii) emergency suspension of or restriction on such a permit or certification; (iii) a cease and desist order; (iv) civil action for injunctive relief; (v) fine assessment in an amount not to exceed $5,000 – per violation, per day; (vi) any other action or relief provided by law; or (vii) some combination of the foregoing. In addition to any other consequences, a knowing failure to report (or a knowing submission of false information to CSR) is a third-degree felony punishable as provided under Sections 775.082, 775.083 or 775.084, Florida Statutes, plus a criminal fine in an amount not to exceed three times the gross profits on the transaction(s), and payment of court costs and the reasonable costs of investigation and prosecution.

We experienced errors or failures with our CSR submission in a past month, or inadvertently provided incorrect information. What do we do?

CSR supports revisions to previous reports to clear errors and inaccuracies, and submission of historical data to bring your company’s reporting history up to date.  Review the appropriate sections of the CSR User Guide for further information.

My company just obtained one of the permit types affected by CSR, but was in the controlled substance business after July 1, 2011 under another, unaffected license type. Do we need to report those transactions?

No. Register with CSR under the new, affected permit, and report all Florida controlled substance transactions after receiving the new permit.

My company already submits ARCOS data. Can I just report the Florida-specific portions to CSR?

Probably not.  DEA has unique reporting criteria and requirements, and the substantive controlled substance schedules are different.  More importantly, Florida law requires reporting of all controlled substance distributions, Schedules II through V, inclusive.  This differs significantly from DEA’s ARCOS reporting requirements.  Florida’s schedules are set forth in Section 893.03, Florida Statutes.

My company currently submits ARCOS reports to DEA on a schedule other than monthly. Can I do the same with Florida’s CSR?

No.  Florida law requires monthly reporting.

My company is registered with CSR, but we did not do any controlled substance business in Florida last month. Do I still have to submit a monthly report?

Yes. If no controlled substance distributions occurred during a given month, a report to that effect must still be submitted.

I am a doctor, pharmacist or other health care practitioner who prescribes or dispenses controlled substances. Do I need to report to CSR?

Probably not, unless you are distributing (selling, transferring, delivering, shipping, etc.) controlled substances to someone other than a patient or consumer. If you are only prescribing and dispensing prescriptions for controlled substances to patients or consumers, then you may need to register with and report to E-FORCSE. Note: Community Pharmacies also holding a Retail Pharmacy Drug Wholesale Distributor permit may need to register with and report to both CSR and E-FORCSE. See FAQ #1 for more information.

What is the difference between E-FORCSE and CSR?

What is the difference between E-FORCSE and CSR? E-FORCSE collects information about retail controlled substance transactions such as prescribing by a physician or dispensing by a pharmacist.  CSR collects information about wholesale transactions such as shipments to pharmacies.  E-FORCSE is maintained and operated by a different agency, the Florida Department of Health.  For more information visit the E-FORCSE homepage at http://www.floridahealth.gov/reports-and-data/e-forcse/index.html. NOTICE: You are now leaving the DBPR Internet website. DBPR is not responsible for the content of the Internet website you are entering. DBPR neither warrants nor makes any representations nor endorsements as to the accuracy, quality, content or completeness of the information, text, images, graphics, hyperlinks and other items contained on the Internet website you are entering. DBPR is not responsible or liable for any viruses or contaminations of your hardware, software, peripherals or property, resulting from use of Internet websites linked to or from the DBPR Internet website.

What are the licensing requirements for selling CBD topical products?

If you are not manufacturing the Hemp topical products to sell online, no permit is required.

Are there any restrictions on selling CBD topical products that are bought from a manufacturer?

Please check with the Federal Food and Drug Administration for information if you are ONLY selling.

What are the regulation and licensing process on the resale of CBD topical products?

If you are not manufacturing the CBD topical products to sell online, no permit is required. Please check with the Federal Food and Drug Administration for selling CBD products.

Does a retailer who is trying to sell CBD topical need to be licensed with DBPR?

If you are not manufacturing the product, no permit is required. You are encouraged to review information provided by the Federal Food and Drug Administration regarding CBD.

What are the legal regulations to sell CBD infused food products?

Please contact the Florida Department of Agricultural and Consumer Services.

Do I need a license to sale CBD topical products that I buy from a direct sales company?

If you are not repackaging the product and you are ONLY selling the product, no permit is required. You are encouraged to review information provided by the Federal Food and Drug Administration regarding CBD.

Are CBD topical products regulated? If so, what are the regulations?

Yes, topical products whether containing CBD or not are regulated by federal law that applies in Florida. If you are manufacturing the product in Florida, the Florida law set forth in chapter 499, Florida Statutes applies. The Federal laws and regulations also apply to the topical products regarding good manufacturing practices, adulteration and misbranding. You are encouraged to review information provided by the Federal Food and Drug Administration regarding CBD.

If selling CBD topical products to manufacturers, is a permit needed from the Division of Drugs, Devices, & Cosmetics? If needed, what are the requirements and processing time?

Yes if you are manufacturing the CBD topical products in Florida to sell to the manufacturers. Please see Chapter 499, Florida Statutes. Time varies on application processing. We process in the order in which the application was received.

What is a Certificate of Free Sale?

A certificate of free sale is a document evidencing that goods such as drugs, cosmetics, or medical devices are legally sold or distributed in the open market and approved by the regulatory authorities in the country of origin.

Where can I obtain a Certificate of Free Sale (COFS)?

a. Drugs – The Division is authorized to issue a COFS to Florida permitted prescription drug manufacturers, prescription drug repackagers, and over-the-counter manufacturers for any product that they have registered with the Division.

Certificate of Free Sale Application

b. Cosmetics – Effective July 1, 2017, the Division will no longer be authorized to issue a COFS for cosmetic products, including those products that are currently registered with the Division and the registration’s expiration date is July 1, 2017, or later. c. To assist you in your efforts to obtain a COFS, the following resources have been identified as entities who have indicated the ability to issue certificates of free sale and certificates of origin: U.S. Food and Drug Administration For information, visit the FDA website. Fees/Requirements: • $10 fee for food, food additives, seafood, dietary supplements and cosmetics • $175 maximum fee for human or animal drugs and biologics (fees vary on product type but will not exceed $175) • FDA website offers FDA point of contact broken out by product and step-by-step instructions for obtaining a certificate online. Enterprise Florida For information, call (305) 808-3660 or download the PDF flyer [ ]. Fees/requirements: • $30 per document (includes certification and notarization) • Completed Certificate of Free Sale • Manufacturer’s declaration stating products are manufactured in the United States • Copy of recently paid invoice to substantiate products freely sold in United States Florida Chamber of Commerce For information, call (850) 521-1200, email internationalfl@flchamber.com, or visit the Florida Chamber of Commerce website. http://www.flchamber.com/certificate-of-free-sale/ Fees/requirements: Regular processing (up to two weeks) • Member rate: $60 per certificate • Non-member rate: $80 per certificate Apostille • $25 additional per certificate (allow for extra processing time) Expedited processing (1-2 days for processing; call to confirm availability) • Member rate: $150 Non-member rate: $175 All fees must be paid in advance and are non-refundable. Each certificate covers the first 100 products; orders exceeding this amount will be charged $25 for each additional certificate. Bulk users (requiring more than 25 certificates a month) will be charged a flat rate. Please contact the Florida Chamber Miami International Trade Office for information on how to qualify. • Completed U.S. Certificate of Origin form available on the UPS website. • Must take the completed certificate into the Chamber Office to be notarized. The Division of Drugs, Devices, and Cosmetics neither endorses these resources nor approves of links to external sources. External links are made available for the convenience of the Internet user. The State of Florida takes no responsibility for a link’s operation or content. The links that are shown are not an exclusive listing of organizations available within the State.

Why does Florida have a Cancer Drug Donation Program?

The purpose of the CDDP is to provide access to the drugs and supplies used to treat cancer to patients who are uninsured and do not qualify for Medicare, third-party insurance or any other state or federal programs. Section 499.029, Florida Statutes, authorizes the donation of cancer drugs and supplies by any person or entity to a participant facility for re-dispensing to an eligible recipient. 61N.1.026 Florida Administrative Code addresses the following: Recipient eligibility requirements; 1. Donor eligibility requirements; 2. Participant facility requirements; 3. Record keeping requirements; 4. Required forms 5. Dispensing fees; 6. Categories of drugs and supplies that may be accepted for donation 7. The creation of a website to be maintained by the Department of Business and Professional Regulations.

Who can donate cancer drugs and supplies?

Drugs may be donated to a participant facility by the following individuals or entities: 1. A cancer patient or their authorized representative. Donations will be made on the patient’s behalf by the healthcare facility where they are receiving treatment (e.g., nursing homes, hospices, or hospitals). 2. A physician licensed under Chapter 458 or 459, Florida Statutes, who receives cancer drugs or supplies directly from a manufacturer, wholesaler, or pharmacy. 3. A pharmacy. 4. A drug manufacturer. 5. A medical device manufacturer. 6. A wholesaler of drugs or supplies

What is a participant facility?

A participant facility is a hospital pharmacy that elects to participate in the program, and accepts donated cancer drugs and supplies under the program.

How does a hospital pharmacy become a participant facility?

The hospital pharmacy must complete and submit a Notice of Participation form to the Program Office. This form can be found on our website at: http://www.myfloridalicense.com/dbpr/ddc/documents/NoticeofParticipationWithdrawal-form.pdf

How does a participating hospital discontinue their participation?

A participant facility may discontinue their participation in the program by completing the Notice of Withdrawal form. This form can be found on our website at: http://www.myfloridalicense.com/dbpr/ddc/documents/NoticeofParticipationWithdrawal-form.pdf

What are the drug donation requirements?

Donations must: 1. Never have been in the actual control of the patient, but rather have been maintained by a health care facility (e.g., nursing home, hospice, or hospital). 2. Be accompanied by a completed Program Donation and Destruction Record Form that is signed by the donor or that person’s authorized representative. 3. The drug is not adulterated, misbranded, or mislabeled. 4. The drug will not expire until at least six months after the donation is made. 5. The drug is in its original, unopened tamper-evident unit dose packaging.

What is an adulterated, misbranded, or mislabeled prescription?

Adulterated means the medication has degraded, been stored improperly or has had something happen to it where the medication is no longer safe to use. Misbranded or mislabeled may mean the medication was originally labeled incorrectly and, therefore, makes the medication unsafe to use.

What does tamper evident unit dose packaging mean? Can I donate medications that I received from the pharmacy in a bottle?

Tamper evident unit dose packaging is packaging where each individual pill is sealed in a plastic bubble typically with a foil type backing. Eligible packaging may also be and inhaler sealed in a foil wrapper or an injectable medication with the manufacturer vial cap intact. Medications received from a pharmacy in the typical brown or amber bottle are not eligible for donation.

Can controlled substances be donated?

Controlled substances such as morphine, oxycodone or lorazepam cannot be donated. These medications are typically used for pain, anxiety and sleep and cannot be returned to a pharmacy or medical facility according to federal law.

Where can I donate my prescription?

There are currently 15 participant hospital pharmacies. For a list please visit Drugs, Devices and Cosmetics page.

Can cancer drugs and supplies be donated from people in other states?

No, cancer drugs may not be donated from people in other states. Donations must be made by facilities, physicians, pharmacies, drug manufacturers, medical device manufacturers, or drug wholesalers who are licensed in the State of Florida.

Who is eligible to receive the medications?

Florida residents (1) who have a valid prescription from their physician, (2) who have been diagnosed with cancer, and (3) who are uninsured and do not qualify for third-party insurance coverage, Medicaid, or any other state or federal assistance programs.

Is there a charge to receive the medications or supplies?

Pharmacies may charge a fee up to $15, for the counseling, preparation and documentation they are required to do when dispensing donated medications.

How do we find out which medications are available?

Please contact the participating pharmacies regarding which medications they may have available. They can be found on the Drugs, Devices and Cosmetics page. Or Search the Medication Supply Availability Form at the following website. Cancer Drug Program page.

Need Help?

All requests for publications, documents, forms, applications for licenses, permits and other similar certifications can be obtained by contacting the Customer Contact Center.

Walter Copeland, Division Director

Division of Drugs, Devices and Cosmetics
2601 Blair Stone Road
Tallahassee, FL 32399-1047

Telephone: 850.717.1800