Drugs, Devices & Cosmetics FAQs

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 DescriptionLocationPermit (Generally) Required under Chapter 499?
Manufacturing a Drug, Device or CosmeticIn FloridaYes
Repackaging a Drug, Device or CosmeticIn FloridaYes
Distributing a Prescription DrugIn or Into FloridaYes
Distributing an Over-the-Counter DrugIn or Into FloridaNo
Distributing a DeviceIn or Into FloridaNo
Distributing a CosmeticIn or Into FloridaNo

 

  • 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?
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. Common types of ownership changes:

Transaction DescriptionNew 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 transactionYes
Merger or acquisition where permittee survives the transaction, and controlling interest in the permittee has not changedUsually No
Change of ownership of the permittee’s parent entityUsually No
Change of ownership of the permittee’s “grandparent” entityAlmost Never
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.
  • Health Care Entity Own-Use Repackaging. A Restricted Prescription Drug Distributor – Health Care Entity permit holder does not require a separate prescription drug repackager permit to repackage prescription drugs in this state for its own use or for distribution to hospitals or other health care entities in the state under common control for those entities’ own use. The permit holder must (a) notify the department in writing of its intention to engage in repackaging 30 days before beginning repackaging operations, (b) adhere to current state and federal good manufacturing practices, and (c) label the prescription drugs in accordance with state and federal laws and rules.
  • 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?
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.

Can I change my physical address online?

Not at this time. Please mail the Change of Address form along with payment made payable to Florida Department of Business and Professional Regulation to 2601 Blair Stone Road, Tallahassee, Florida  32399-1047.

How do I change my mailing address?

You may submit a written request to: Department of Business and Professional Regulation, 2601 Blair Stone Road, Tallahassee, FL 32399-0783.

How do I change the name on my permit?

Mail the Change of Address/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 45 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?
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.

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.

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?

No, you must mail the fingerprint card and the $47.00 fee to the Department of Business and Professional Regulation, 2601 Blair Stone Road, Tallahassee, FL 32399-1047.

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.

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 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.

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.

Drew Winters, Division Director

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

Telephone: 850.717.1800