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2011 Florida Statutes

F.S. 499.01
499.01 Permits.
(1) Prior to operating, a permit is required for each person and establishment that intends to operate as:
(a) A prescription drug manufacturer;
(b) A prescription drug repackager;
(c) A nonresident prescription drug manufacturer;
(d) A prescription drug wholesale distributor;
(e) An out-of-state prescription drug wholesale distributor;
(f) A retail pharmacy drug wholesale distributor;
(g) A restricted prescription drug distributor;
(h) A complimentary drug distributor;
(i) A freight forwarder;
(j) A veterinary prescription drug retail establishment;
(k) A veterinary prescription drug wholesale distributor;
(l) A limited prescription drug veterinary wholesale distributor;
(m) A medical oxygen retail establishment;
(n) A compressed medical gas wholesale distributor;
(o) A compressed medical gas manufacturer;
(p) An over-the-counter drug manufacturer;
(q) A device manufacturer;
(r) A cosmetic manufacturer;
(s) A third party logistics provider; or
(t) A health care clinic establishment.
(2) The following permits are established:
(a) Prescription drug manufacturer permit.A prescription drug manufacturer permit is required for any person that is a manufacturer of a prescription drug and that manufactures or distributes such prescription drugs in this state.
1. A person that operates an establishment permitted as a prescription drug manufacturer may engage in wholesale distribution of prescription drugs manufactured at that establishment and must comply with all of the provisions of this part, except s. 499.01212, and the rules adopted under this part, except s. 499.01212, that apply to a wholesale distributor.
2. A prescription drug manufacturer must comply with all appropriate state and federal good manufacturing practices.
(b) Prescription drug repackager permit.A prescription drug repackager permit is required for any person that repackages a prescription drug in this state.
1. A person that operates an establishment permitted as a prescription drug repackager may engage in wholesale distribution of prescription drugs repackaged at that establishment and must comply with all the provisions of this part and the rules adopted under this part that apply to a wholesale distributor.
2. A prescription drug repackager must comply with all appropriate state and federal good manufacturing practices.
(c) Nonresident prescription drug manufacturer permit.A nonresident prescription drug manufacturer permit is required for any person that is a manufacturer of prescription drugs, unless permitted as a third party logistics provider, located outside of this state or outside the United States and that engages in the wholesale distribution in this state of such prescription drugs. Each such manufacturer must be permitted by the department and comply with all of the provisions required of a wholesale distributor under this part, except s. 499.01212.
1. A person that distributes prescription drugs for which the person is not the manufacturer must also obtain an out-of-state prescription drug wholesale distributor permit or third party logistics provider permit pursuant to this section to engage in the wholesale distribution of such prescription drugs. This subparagraph does not apply to a manufacturer as defined in s. 499.003(31)(e).
2. Any such person must comply with the licensing or permitting requirements of the jurisdiction in which the establishment is located and the federal act, and any product wholesaled into this state must comply with this part. If a person intends to import prescription drugs from a foreign country into this state, the nonresident prescription drug manufacturer must provide to the department a list identifying each prescription drug it intends to import and document approval by the United States Food and Drug Administration for such importation.
3. A nonresident prescription drug manufacturer permit is not required for a manufacturer to distribute a prescription drug active pharmaceutical ingredient that it manufactures to a prescription drug manufacturer permitted in this state 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 manufacturer claiming to be exempt from the permit requirements of this subparagraph and the prescription drug manufacturer purchasing and receiving the active pharmaceutical ingredient shall comply with the recordkeeping requirements of s. 499.0121(6), but not the requirements of s. 499.01212. The prescription drug manufacturer purchasing and receiving the active pharmaceutical ingredient shall maintain on file a record of the FDA registration number; the out-of-state license, permit, or registration number; and, if available, a copy of the most current FDA inspection report, for all manufacturers from whom they purchase active pharmaceutical ingredients under this section. The department shall specify by rule the allowable number of transactions within a given period of time and the amount of active pharmaceutical ingredients that qualify as limited quantities for purposes of this exemption. The failure to comply with the requirements of this subparagraph, or rules adopted by the department to administer this subparagraph, for the purchase of prescription drug active pharmaceutical ingredients is a violation of s. 499.005(14).
(d) Prescription drug wholesale distributor permit.A prescription drug wholesale distributor is a wholesale distributor that may engage in the wholesale distribution of prescription drugs. A prescription drug wholesale distributor that applies to the department for a new permit or the renewal of a permit must submit a bond of $100,000, or other equivalent means of security acceptable to the department, such as an irrevocable letter of credit or a deposit in a trust account or financial institution, payable to the Florida Drug, Device, and Cosmetic Trust Fund. The purpose of the bond is to secure payment of any administrative penalties imposed by the department and any fees and costs incurred by the department regarding that permit which are authorized under state law and which the permittee fails to pay 30 days after the fine or costs become final. The department may make a claim against such bond or security until 1 year after the permittee’s license ceases to be valid or until 60 days after any administrative or legal proceeding authorized in this part which involves the permittee is concluded, including any appeal, whichever occurs later. The department may adopt rules for issuing a prescription drug wholesale distributor-broker permit to a person who engages in the wholesale distribution of prescription drugs and does not take physical possession of any prescription drugs.
(e) Out-of-state prescription drug wholesale distributor permit.An out-of-state prescription drug wholesale distributor is a wholesale distributor located outside this state which engages in the wholesale distribution of prescription drugs into this state and which must be permitted by the department and comply with all the provisions required of a wholesale distributor under this part. An out-of-state prescription drug wholesale distributor that applies to the department for a new permit or the renewal of a permit must submit a bond of $100,000, or other equivalent means of security acceptable to the department, such as an irrevocable letter of credit or a deposit in a trust account or financial institution, payable to the Florida Drug, Device, and Cosmetic Trust Fund. The purpose of the bond is to secure payment of any administrative penalties imposed by the department and any fees and costs incurred by the department regarding that permit which are authorized under state law and which the permittee fails to pay 30 days after the fine or costs become final. The department may make a claim against such bond or security until 1 year after the permittee’s license ceases to be valid or until 60 days after any administrative or legal proceeding authorized in this part which involves the permittee is concluded, including any appeal, whichever occurs later.
1. The out-of-state prescription drug wholesale distributor must maintain at all times a license or permit to engage in the wholesale distribution of prescription drugs in compliance with laws of the state in which it is a resident.
2. 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. The recordkeeping requirements of ss. 499.0121(6) and 499.01212 must be followed for this transaction.
(f) Retail pharmacy drug wholesale distributor permit.A retail pharmacy drug wholesale distributor is a retail pharmacy engaged in wholesale distribution of prescription drugs within this state under the following conditions:
1. The pharmacy must obtain a retail pharmacy drug wholesale distributor permit pursuant to this part and the rules adopted under this part.
2. The wholesale distribution activity does not exceed 30 percent of the total annual purchases of prescription drugs. If the wholesale distribution activity exceeds the 30-percent maximum, the pharmacy must obtain a prescription drug wholesale distributor permit.
3. The transfer of prescription drugs that appear in any schedule contained in chapter 893 is subject to chapter 893 and the federal Comprehensive Drug Abuse Prevention and Control Act of 1970.
4. The transfer is between a retail pharmacy and another retail pharmacy, or a Modified Class II institutional pharmacy, or a health care practitioner licensed in this state and authorized by law to dispense or prescribe prescription drugs.
5. All records of sales of prescription drugs subject to this section must be maintained separate and distinct from other records and comply with the recordkeeping requirements of this part.
(g) Restricted prescription drug distributor permit.A restricted prescription drug distributor permit is required for any person that engages in the distribution of a prescription drug, which distribution is not considered “wholesale distribution” under s. 499.003(54)(a).
1. A person who engages in the receipt or distribution of a prescription drug in this state for the purpose of processing its return or its destruction must obtain a permit as a restricted prescription drug distributor if such person is not the person initiating the return, the prescription drug wholesale supplier of the person initiating the return, or the manufacturer of the drug.
2. Storage, handling, and recordkeeping of these distributions must comply with the requirements for wholesale distributors under s. 499.0121, but not those set forth in s. 499.01212.
3. A person who applies for a permit as a restricted prescription drug distributor, or for the renewal of such a permit, must provide to the department the information required under s. 499.012.
4. The department may adopt rules regarding the distribution of prescription drugs by hospitals, health care entities, charitable organizations, or other persons not involved in wholesale distribution, which rules are necessary for the protection of the public health, safety, and welfare.
(h) Complimentary drug distributor permit.A complimentary drug distributor permit is required for any person that engages in the distribution of a complimentary drug, subject to the requirements of s. 499.028.
(i) Freight forwarder permit.A freight forwarder permit is required for any person that engages in the distribution of a prescription drug as a freight forwarder unless the person is a common carrier. The storage, handling, and recordkeeping of such distributions must comply with the requirements for wholesale distributors under s. 499.0121, but not those set forth in s. 499.01212. A freight forwarder must provide the source of the prescription drugs with a validated airway bill, bill of lading, or other appropriate documentation to evidence the exportation of the product.
(j) Veterinary prescription drug retail establishment permit.A veterinary prescription drug retail establishment permit is required for any person that sells veterinary prescription drugs to the public but does not include a pharmacy licensed under chapter 465.
1. The sale to the public must be based on a valid written order from a veterinarian licensed in this state who has a valid client-veterinarian relationship with the purchaser’s animal.
2. Veterinary prescription drugs may not be sold in excess of the amount clearly indicated on the order or beyond the date indicated on the order.
3. An order may not be valid for more than 1 year.
4. A veterinary prescription drug retail establishment may not purchase, sell, trade, or possess human prescription drugs or any controlled substance as defined in chapter 893.
5. A veterinary prescription drug retail establishment must sell a veterinary prescription drug in the original, sealed manufacturer’s container with all labeling intact and legible. The department may adopt by rule additional labeling requirements for the sale of a veterinary prescription drug.
6. A veterinary prescription drug retail establishment must comply with all of the wholesale distribution requirements of s. 499.0121.
7. Prescription drugs sold by a veterinary prescription drug retail establishment pursuant to a practitioner’s order may not be returned into the retail establishment’s inventory.
(k) Veterinary prescription drug wholesale distributor permit.A veterinary prescription drug wholesale distributor permit is required for any person that engages in the distribution of veterinary prescription drugs in or into this state. A veterinary prescription drug wholesale distributor that also distributes prescription drugs subject to, defined by, or described by s. 503(b) of the Federal Food, Drug, and Cosmetic Act which it did not manufacture must obtain a permit as a prescription drug wholesale distributor, an out-of-state prescription drug wholesale distributor, or a limited prescription drug veterinary wholesale distributor in lieu of the veterinary prescription drug wholesale distributor permit. A veterinary prescription drug wholesale distributor must comply with the requirements for wholesale distributors under s. 499.0121, but not those set forth in s. 499.01212.
(l) Limited prescription drug veterinary wholesale distributor permit.Unless engaging in the activities of and permitted as a prescription drug manufacturer, nonresident prescription drug manufacturer, prescription drug wholesale distributor, or out-of-state prescription drug wholesale distributor, a limited prescription drug veterinary wholesale distributor permit is required for any person that engages in the distribution in or into this state of veterinary prescription drugs and prescription drugs subject to, defined by, or described by s. 503(b) of the Federal Food, Drug, and Cosmetic Act under the following conditions:
1. The person is engaged in the business of wholesaling prescription and veterinary prescription drugs to persons:
a. Licensed as veterinarians practicing on a full-time basis;
b. Regularly and lawfully engaged in instruction in veterinary medicine;
c. Regularly and lawfully engaged in law enforcement activities;
d. For use in research not involving clinical use; or
e. For use in chemical analysis or physical testing or for purposes of instruction in law enforcement activities, research, or testing.
2. No more than 30 percent of total annual prescription drug sales may be prescription drugs approved for human use which are subject to, defined by, or described by s. 503(b) of the Federal Food, Drug, and Cosmetic Act.
3. The person does not distribute in any jurisdiction prescription drugs subject to, defined by, or described by s. 503(b) of the Federal Food, Drug, and Cosmetic Act to any person who is authorized to sell, distribute, purchase, trade, or use these drugs on or for humans.
4. A limited prescription drug veterinary wholesale distributor that applies to the department for a new permit or the renewal of a permit must submit a bond of $20,000, or other equivalent means of security acceptable to the department, such as an irrevocable letter of credit or a deposit in a trust account or financial institution, payable to the Florida Drug, Device, and Cosmetic Trust Fund. The purpose of the bond is to secure payment of any administrative penalties imposed by the department and any fees and costs incurred by the department regarding that permit which are authorized under state law and which the permittee fails to pay 30 days after the fine or costs become final. The department may make a claim against such bond or security until 1 year after the permittee’s license ceases to be valid or until 60 days after any administrative or legal proceeding authorized in this part which involves the permittee is concluded, including any appeal, whichever occurs later.
5. A limited prescription drug veterinary wholesale distributor must maintain at all times a license or permit to engage in the wholesale distribution of prescription drugs in compliance with laws of the state in which it is a resident.
6. A limited prescription drug veterinary wholesale distributor must comply with the requirements for wholesale distributors under ss. 499.0121 and 499.01212, except that a limited prescription drug veterinary wholesale distributor is not required to provide a pedigree paper as required by s. 499.01212 upon the wholesale distribution of a prescription drug to a veterinarian.
7. A limited prescription drug veterinary wholesale distributor may not return to inventory for subsequent wholesale distribution any prescription drug subject to, defined by, or described by s. 503(b) of the Federal Food, Drug, and Cosmetic Act which has been returned by a veterinarian.
8. A limited prescription drug veterinary 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 to engage in the wholesale distribution of prescription drugs in its state of residence to a licensed limited prescription drug veterinary wholesale distributor in this state if both wholesale distributors conduct wholesale distributions of prescription drugs under the same business name. The recordkeeping requirements of ss. 499.0121(6) and 499.01212 must be followed for this transaction.
(m) Medical oxygen retail establishment permit.A medical oxygen retail establishment permit is required for any person that sells medical oxygen to patients only. The sale must be based on an order from a practitioner authorized by law to prescribe. The term does not include a pharmacy licensed under chapter 465.
1. A medical oxygen retail establishment may not possess, purchase, sell, or trade any prescription drug other than medical oxygen.
2. A medical oxygen retail establishment may refill medical oxygen for an individual patient based on an order from a practitioner authorized by law to prescribe. A medical oxygen retail establishment that refills medical oxygen must comply with all appropriate state and federal good manufacturing practices.
3. A medical oxygen retail establishment must comply with all of the wholesale distribution requirements of s. 499.0121.
4. Prescription medical oxygen sold by a medical oxygen retail establishment pursuant to a practitioner’s order may not be returned into the retail establishment’s inventory.
(n) Compressed medical gas wholesale distributor permit.A compressed medical gas wholesale distributor is a wholesale distributor that is limited to the wholesale distribution of compressed medical gases to other than the consumer or patient. The compressed medical gas must be in the original sealed container that was purchased by that wholesale distributor. A compressed medical gas wholesale distributor may not possess or engage in the wholesale distribution of any prescription drug other than compressed medical gases. The department shall adopt rules that govern the wholesale distribution of prescription medical oxygen for emergency use. With respect to the emergency use of prescription medical oxygen, those rules may not be inconsistent with rules and regulations of federal agencies unless the Legislature specifically directs otherwise.
(o) Compressed medical gas manufacturer permit.A compressed medical gas manufacturer permit is required for any person that engages in the manufacture of compressed medical gases or repackages compressed medical gases from one container to another.
1. A compressed medical gas manufacturer may not manufacture or possess any prescription drug other than compressed medical gases.
2. A compressed medical gas manufacturer may engage in wholesale distribution of compressed medical gases manufactured at that establishment and must comply with all the provisions of this part and the rules adopted under this part that apply to a wholesale distributor.
3. A compressed medical gas manufacturer must comply with all appropriate state and federal good manufacturing practices.
(p) Over-the-counter drug manufacturer permit.An over-the-counter drug manufacturer permit is required for any person that engages in the manufacture or repackaging of an over-the-counter drug.
1. An over-the-counter drug manufacturer may not possess or purchase prescription drugs.
2. A pharmacy is exempt from obtaining an over-the-counter drug manufacturer permit if it is operating in compliance with pharmacy practice standards as defined in chapter 465 and the rules adopted under that chapter.
3. An over-the-counter drug manufacturer must comply with all appropriate state and federal good manufacturing practices.
(q) Device manufacturer permit.
1. A device manufacturer permit is required for any person that engages in the manufacture, repackaging, or assembly of medical devices for human use in this state, except that a permit is not required if:
a. The person is engaged only in manufacturing, repackaging, or assembling a medical device pursuant to a practitioner’s order for a specific patient; or
b. The person does not manufacture, repackage, or assemble any medical devices or components for such devices, except those devices or components which are exempt from registration pursuant to s. 499.015(8).
2. A manufacturer or repackager of medical devices in this state must comply with all appropriate state and federal good manufacturing practices and quality system rules.
3. The department shall adopt rules related to storage, handling, and recordkeeping requirements for manufacturers of medical devices for human use.
(r) Cosmetic manufacturer permit.A cosmetic manufacturer permit is required for any person that manufactures or repackages cosmetics in this state. A person that only labels or changes the labeling of a cosmetic but does not open the container sealed by the manufacturer of the product is exempt from obtaining a permit under this paragraph.
(s) Third party logistics provider permit.A third party logistics provider permit is required for any person that contracts with a prescription drug wholesale distributor or prescription drug manufacturer to provide warehousing, distribution, or other logistics services on behalf of a manufacturer or wholesale distributor, but who does not take title to the prescription drug or have responsibility to direct the sale or disposition of the prescription drug. Each third party logistics provider permittee shall comply with the requirements for wholesale distributors under ss. 499.0121 and 499.01212, with the exception of those wholesale distributions described in s. 499.01212(3)(a), and other rules that the department requires.
(t) Health care clinic establishment permit.Effective January 1, 2009, a health care clinic establishment permit is required for the purchase of a prescription drug by a place of business at one general physical location that provides health care or veterinary services, which is owned and operated by a business entity that has been issued a federal employer tax identification number. For the purpose of this paragraph, the term “qualifying practitioner” means a licensed health care practitioner defined in s. 456.001, or a veterinarian licensed under chapter 474, who is authorized under the appropriate practice act to prescribe and administer a prescription drug.
1. An establishment must provide, as part of the application required under s. 499.012, designation of a qualifying practitioner who will be responsible for complying with all legal and regulatory requirements related to the purchase, recordkeeping, storage, and handling of the prescription drugs. In addition, the designated qualifying practitioner shall be the practitioner whose name, establishment address, and license number is used on all distribution documents for prescription drugs purchased or returned by the health care clinic establishment. Upon initial appointment of a qualifying practitioner, the qualifying practitioner and the health care clinic establishment shall notify the department on a form furnished by the department within 10 days after such employment. In addition, the qualifying practitioner and health care clinic establishment shall notify the department within 10 days after any subsequent change.
2. The health care clinic establishment must employ a qualifying practitioner at each establishment.
3. In addition to the remedies and penalties provided in this part, a violation of this chapter by the health care clinic establishment or qualifying practitioner constitutes grounds for discipline of the qualifying practitioner by the appropriate regulatory board.
4. The purchase of prescription drugs by the health care clinic establishment is prohibited during any period of time when the establishment does not comply with this paragraph.
5. A health care clinic establishment permit is not a pharmacy permit or otherwise subject to chapter 465. A health care clinic establishment that meets the criteria of a modified Class II institutional pharmacy under s. 465.019 is not eligible to be permitted under this paragraph.
6. This paragraph does not apply to the purchase of a prescription drug by a licensed practitioner under his or her license.
History.s. 34, ch. 82-225; s. 108, ch. 83-218; s. 1, ch. 83-265; ss. 14, 15, 18, 19, 52, ch. 92-69; ss. 30, 31, 34, 35, ch. 98-151; ss. 37, 40, ch. 2000-242; s. 20, ch. 2001-53; s. 138, ch. 2001-277; ss. 11, 12, 13, 14, 18, 19, ch. 2003-155; s. 85, ch. 2004-5; ss. 2, 3, ch. 2004-328; ss. 2, 3, ch. 2006-92; ss. 22, 25, ch. 2007-6; ss. 10, 11, ch. 2008-207; s. 2, ch. 2009-221; ss. 23, 39, ch. 2010-161.
Note.Subsection (2) intro. former s. 499.012(2) intro.; paragraph (2)(c) former s. 499.012(2)(e); paragraph (2)(d) former s. 499.012(2)(a); paragraph (2)(e) former s. 499.012(2)(c); paragraph (2)(f) former s. 499.012(2)(d); paragraph (2)(g) former s. 499.014; paragraph (2)(i) former s. 499.012(2)(f); paragraph (2)(k) former s. 499.012(2)(g); paragraph (2)(l) former s. 499.012(2)(h); paragraph (2)(n) former s. 499.012(2)(b); paragraph (2)(o) former s. 499.013(2)(c); paragraph (2)(p) former s. 499.013(2)(b); paragraph (2)(q) former s. 499.013(2)(d); paragraph (2)(r) former s. 499.013(2)(e).