eLaws of Florida

  SECTION 499.01. Permits.  


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  • 112(1) 3Before operating, a permit is required for each person and establishment that intends to operate as:
    19(a) 20A prescription drug manufacturer;
    24(b) 25A prescription drug repackager;
    29(c) 30A nonresident prescription drug manufacturer;
    35(d) 36A nonresident prescription drug repackager;
    41(e) 42A prescription drug wholesale distributor;
    47(f) 48An out-of-state prescription drug wholesale distributor;
    54(g) 55A retail pharmacy drug wholesale distributor;
    61(h) 62A restricted prescription drug distributor;
    67(i) 68A complimentary drug distributor;
    72(j) 73A freight forwarder;
    76(k) 77A veterinary prescription drug retail establishment;
    83(l) 84A veterinary prescription drug wholesale distributor;
    90(m) 91A limited prescription drug veterinary wholesale distributor;
    98(n) 99An over-the-counter drug manufacturer;
    103(o) 104A device manufacturer;
    107(p) 108A cosmetic manufacturer;
    111(q) 112A third party logistics provider; or
    118(r) 119A health care clinic establishment.
    1241125(2) 126The following permits are established:
    131(a) 132Prescription drug manufacturer permit.136-137A 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.
    1661. 167A person that operates an establishment permitted as a prescription drug manufacturer may engage in distribution of prescription drugs for which the person is the manufacturer and must comply with s. 198499.0121 199and all other provisions of this part and rules adopted under this part. The department shall adopt rules for issuing a virtual prescription drug manufacturer permit to a person who engages in the manufacture of prescription drugs but does not make or take physical possession of any prescription drugs. The rules adopted by the department under this section may exempt virtual manufacturers from certain establishment, security, and storage requirements set forth in s. 272499.0121273.
    2742. 275A prescription drug manufacturer must comply with all appropriate state and federal good manufacturing practices.
    2903. 291A blood establishment, as defined in s. 298381.06014, 299operating in a manner consistent with the provisions of 21 C.F.R. parts 211 and 600-640, and manufacturing only the prescription drugs described in s. 323499.003(48)(j) 324is not required to be permitted as a prescription drug manufacturer under this paragraph or to register products under s. 344499.015345.
    346(b) 347Prescription drug repackager permit.351-352A prescription drug repackager permit is required for any person that repackages a prescription drug in this state.
    3701. 371A person that operates an establishment permitted as a prescription drug repackager may engage in distribution of prescription drugs repackaged at that establishment and must comply with all of the provisions of this part and the rules adopted under this part that apply to a prescription drug manufacturer.
    4192. 420A prescription drug repackager must comply with all appropriate state and federal good manufacturing practices.
    4353. 436A prescription drug repackager permit is not required for distributing medicinal drugs or prepackaged drug products between entities under common control which each hold either an active Class III institutional pharmacy permit under chapter 465 or an active health care clinic establishment permit under paragraph (r). For purposes of this subparagraph, the term “common control” has the same meaning as in s. 498499.003(48)(a)3499.
    5001501(c) 502Nonresident prescription drug manufacturer permit.507-508A 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 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 prescription drug manufacturer under this part. The department shall adopt rules for issuing a virtual nonresident prescription drug manufacturer permit to a person who engages in the manufacture of prescription drugs but does not make or take physical possession of any prescription drugs. The rules adopted by the department under this section may exempt virtual nonresident manufacturers from certain establishment, security, and storage requirements set forth in s. 644499.0121645.
    6461. 647A 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 distribution of such prescription drugs when required by this part. This subparagraph does not apply to a manufacturer that distributes prescription drugs only for the manufacturer of the prescription drugs where both manufacturers are affiliates.
    7202. 721Any 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 prescription drug distributed 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.
    807(d) 808Nonresident prescription drug repackager permit.813-814A nonresident prescription drug repackager permit is required for any person located outside of this state, but within the United States or its territories, that repackages prescription drugs and engages in the distribution of such prescription drugs into this state.
    8541. 855A nonresident prescription drug repackager must comply with all of the provisions of this section and the rules adopted under this section that apply to a prescription drug manufacturer.
    8842. 885A nonresident prescription drug repackager must be permitted by the department and comply with all appropriate state and federal good manufacturing practices.
    9073. 908A nonresident prescription drug repackager must be registered as a drug establishment with the United States Food and Drug Administration.
    928(e) 929Prescription drug wholesale distributor permit.934-935A prescription drug wholesale distributor permit is required for any person who is a wholesale distributor of prescription drugs and that wholesale distributes such prescription drugs in this state. 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.
    999(f) 1000Out-of-state prescription drug wholesale distributor permit.1006-1007An out-of-state prescription drug wholesale distributor permit is required for any person that is a wholesale distributor located outside this state, but within the United States or its territories, which engages in the wholesale distribution of prescription drugs into this state. 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. If the state from which the wholesale distributor distributes prescription drugs does not require a license to engage in the wholesale distribution of prescription drugs, the distributor must be licensed as a wholesale distributor as required by the federal act.
    1125(g) 1126Retail pharmacy drug wholesale distributor permit.1132-1133A retail pharmacy drug wholesale distributor is a retail pharmacy engaged in wholesale distribution of prescription drugs within this state under the following conditions:
    11571. 1158The pharmacy must obtain a retail pharmacy drug wholesale distributor permit pursuant to this part and rules adopted under this part.
    11792. 1180The 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.
    12163. 1217The 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.
    12484. 1249The 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.
    12865. 1287All 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.
    1316(h) 1317Restricted prescription drug distributor permit.1322-
    13231. 1324A restricted prescription drug distributor permit is required for:
    1333a. 1334Any person located in this state who engages in the distribution of a prescription drug, which distribution is not considered “wholesale distribution” under s. 1358499.003(48)(a)1359.
    1360b. 1361Any person located in this state who engages in the receipt or distribution of a prescription drug in this state for the purpose of processing its return or its destruction 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.
    1418c. 1419A blood establishment located in this state which collects blood and blood components only from volunteer donors as defined in s. 1440381.06014 1441or pursuant to an authorized practitioner’s order for medical treatment or therapy and engages in the wholesale distribution of a prescription drug not described in s. 1467499.003(48)(j) 1468to a health care entity. A mobile blood unit operated by a blood establishment permitted under this sub-subparagraph is not required to be separately permitted. The health care entity receiving a prescription drug distributed under this sub-subparagraph must be licensed as a closed pharmacy or provide health care services at that establishment. The blood establishment must operate in accordance with s. 1529381.06014 1530and may distribute only:
    1534(I) 1535Prescription drugs indicated for a bleeding or clotting disorder or anemia;
    1546(II) 1547Blood-collection containers approved under s. 505 of the federal act;
    1557(III) 1558Drugs that are blood derivatives, or a recombinant or synthetic form of a blood derivative;
    1573(IV) 1574Prescription drugs that are identified in rules adopted by the department and that are essential to services performed or provided by blood establishments and authorized for distribution by blood establishments under federal law; or
    1608(V) 1609To the extent authorized by federal law, drugs necessary to collect blood or blood components from volunteer blood donors; for blood establishment personnel to perform therapeutic procedures under the direction and supervision of a licensed physician; and to diagnose, treat, manage, and prevent any reaction of a volunteer blood donor or a patient undergoing a therapeutic procedure performed under the direction and supervision of a licensed physician,

    1676as long as all of the health care services provided by the blood establishment are related to its activities as a registered blood establishment or the health care services consist of collecting, processing, storing, or administering human hematopoietic stem cells or progenitor cells or performing diagnostic testing of specimens if such specimens are tested together with specimens undergoing routine donor testing. The blood establishment may purchase and possess the drugs described in this sub-subparagraph without a health care clinic establishment permit.

    17572. 1758Storage, handling, and recordkeeping of these distributions by a person required to be permitted as a restricted prescription drug distributor must be in accordance with the requirements for wholesale distributors under s. 1790499.01211791.
    17923. 1793A 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. 1824499.0121825.
    18264. 1827The department may adopt rules regarding the distribution of prescription drugs by hospitals, health care entities, charitable organizations, other persons not involved in wholesale distribution, and blood establishments, which rules are necessary for the protection of the public health, safety, and welfare.
    18695. 1870A restricted prescription drug distributor permit is not required for distributions between pharmacies that each hold an active permit under chapter 465, have a common ownership, and are operating in a freestanding end-stage renal dialysis clinic, if such distributions are made to meet the immediate emergency medical needs of specifically identified patients and do not occur with such frequency as to amount to the regular and systematic supplying of that drug between the pharmacies. The department shall adopt rules establishing when the distribution of a prescription drug under this subparagraph amounts to the regular and systematic supplying of that drug.
    19706. 1971A restricted prescription drug distributor permit is not required for distributing medicinal drugs or prepackaged drug products between entities under common control that each hold either an active Class III institutional pharmacy permit under chapter 465 or an active health care clinic establishment permit under paragraph (r). For purposes of this subparagraph, the term “common control” has the same meaning as in s. 2034499.003(48)(a)32035.
    2036(i) 2037Complimentary drug distributor permit.2041-2042A complimentary drug distributor permit is required for any person that engages in the distribution of a complimentary drug, subject to the requirements of s. 2067499.0282068.
    2069(j) 2070Freight forwarder permit.2073-2074A 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. 2121499.01212122. 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.
    2153(k) 2154Veterinary prescription drug retail establishment permit.2160-2161A 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.
    21911. 2192The 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.
    22222. 2223Veterinary prescription drugs may not be sold in excess of the amount clearly indicated on the order or beyond the date indicated on the order.
    22483. 2249An order may not be valid for more than 1 year.
    22604. 2261A veterinary prescription drug retail establishment may not purchase, sell, trade, or possess human prescription drugs or any controlled substance as defined in chapter 893.
    22865. 2287A 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.
    23286. 2329A veterinary prescription drug retail establishment must comply with all of the wholesale distribution requirements of s. 2346499.01212347.
    23487. 2349Prescription 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.
    2373(l) 2374Veterinary prescription drug wholesale distributor permit.2380-2381A 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. 2490499.01212491.
    2492(m) 2493Limited prescription drug veterinary wholesale distributor permit.2500-2501Unless 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:
    25791. 2580The person is engaged in the business of wholesaling prescription and veterinary prescription drugs to persons:
    2596a. 2597Licensed as veterinarians practicing on a full-time basis;
    2605b. 2606Regularly and lawfully engaged in instruction in veterinary medicine;
    2615c. 2616Regularly and lawfully engaged in law enforcement activities;
    2624d. 2625For use in research not involving clinical use; or
    2634e. 2635For use in chemical analysis or physical testing or for purposes of instruction in law enforcement activities, research, or testing.
    26552. 2656No 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.
    26943. 2695The 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.
    27414. 2742A 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 Professional Regulation 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.
    29045. 2905A 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.
    29436. 2944A limited prescription drug veterinary wholesale distributor must comply with the requirements for wholesale distributors under s. 2961499.01212962.
    29637. 2964A 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.
    30078. 3008A 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 s. 3083499.0121(6) 3084must be followed for this transaction.
    3090(n) 3091Over-the-counter drug manufacturer permit.3095-3096An over-the-counter drug manufacturer permit is required for any person that engages in the manufacture or repackaging of an over-the-counter drug.
    31171. 3118An over-the-counter drug manufacturer may not possess or purchase prescription drugs.
    31292. 3130A 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 rules adopted under that chapter.
    31623. 3163An over-the-counter drug manufacturer must comply with all appropriate state and federal good manufacturing practices.
    3178(o) 3179Device manufacturer permit.3182-
    31831. 3184A 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:
    3218a. 3219The person is engaged only in manufacturing, repackaging, or assembling a medical device pursuant to a practitioner’s order for a specific patient; or
    3242b. 3243The 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. 3272499.015(8)3273.
    32742. 3275A manufacturer or repackager of medical devices in this state must comply with all appropriate state and federal good manufacturing practices and quality system rules.
    33003. 3301The department shall adopt rules related to storage, handling, and recordkeeping requirements for manufacturers of medical devices for human use.
    3321(p) 3322Cosmetic manufacturer permit.3325-3326A 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.
    3377(q) 3378Third party logistics provider permit.3383-3384A 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, wholesale distributor, or dispenser, but who does not take title to the prescription drug or have responsibility to direct the sale or disposition of the prescription drug. A third party logistics provider located outside of this state must be licensed in the state or territory from which the prescription drug is distributed by the third party logistics provider. If the state or territory from which the third party logistics provider originates does not require a license to operate as a third party logistics provider, the third party logistics provider must be licensed as a third party logistics provider as required by the federal act. Each third party logistics provider permittee shall comply with s. 3534499.0121 3535and other rules that the department requires.
    3542(r) 3543Health care clinic establishment permit.3548-3549A 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. 3619456.001, 3620or a veterinarian licensed under chapter 474, who is authorized under the appropriate practice act to prescribe and administer a prescription drug.
    36421. 3643An establishment must provide, as part of the application required under s. 3655499.012, 3656designation 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.
    37742. 3775The health care clinic establishment must employ a qualifying practitioner at each establishment.
    37883. 3789In 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.
    38274. 3828The 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.
    38555. 3856A 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. 3891465.019 3892is not eligible to be permitted under this paragraph.
    39016. 3902This paragraph does not apply to the purchase of a prescription drug by a licensed practitioner under his or her license.
    3923(3) 3924A 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 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 subsection and the prescription drug manufacturer purchasing and receiving the active pharmaceutical ingredient shall comply with the recordkeeping requirements of s. 4014499.0121(6)4015. The prescription drug manufacturer purchasing and receiving the active pharmaceutical ingredient shall maintain on file a record of the FDA registration number; if available, 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 failure to comply with the requirements of this subsection, or rules adopted by the department to administer this subsection, for the purchase of prescription drug active pharmaceutical ingredients is a violation of s. 4106499.005(14), 4107and a knowing failure is a violation of s. 4116499.0051(3)4117.
    4118(a) 4119The immediate package or container of a prescription drug active pharmaceutical ingredient distributed into the state that is intended for research and development under this subsection shall bear a label prominently displaying the statement: “Caution: Research and Development Only4158-4159Not for Manufacturing, Compounding, or Resale.”
    4165(b) 4166A prescription drug manufacturer that obtains a prescription drug active pharmaceutical ingredient under this subsection for use in clinical trials and or biostudies authorized and regulated by federal law must create and maintain records detailing the specific clinical trials or biostudies for which the prescription drug active pharmaceutical ingredient was obtained.
    4217(4)(a) 4218A permit issued under this part is not required to distribute a prescription drug active pharmaceutical ingredient from an establishment located in the United States to an establishment located in this state permitted as a prescription drug manufacturer under this part 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, Abbreviated New Drug Application, New Animal Drug Application, or Therapeutic Biologic Application, 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.
    43371. 4338Any distributor claiming exemption from permitting requirements pursuant to this paragraph shall maintain a license, permit, or registration to engage in the wholesale distribution of prescription drugs under the laws of the state from which the product is distributed. If the state from which the prescription drugs are distributed does not require a license to engage in the wholesale distribution of prescription drugs, the distributor must be licensed as a wholesale distributor as required by the federal act.
    44162. 4417Any distributor claiming exemption from permitting requirements pursuant to this paragraph and the prescription drug manufacturer purchasing and receiving the active pharmaceutical ingredient shall comply with the recordkeeping requirements of s. 4448499.0121(6)4449.
    4450(b) 4451A permit issued under this part is not required to distribute 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 under this part for research and development or to a holder of a letter of exemption issued by the department under s. 4513499.03(4) 4514for research, teaching, or testing.
    45191. 4520Any distributor claiming exemption from permitting requirements pursuant to this paragraph shall maintain a license, permit, or registration to engage in the wholesale distribution of prescription drugs under the laws of the state from which the product is distributed. If the state from which the prescription drugs are distributed does not require a license to engage in the wholesale distribution of prescription drugs, the distributor must be licensed as a wholesale distributor as required by the federal act.
    45982. 4599All purchasers and recipients of any prescription drugs distributed pursuant to this paragraph shall ensure that the products are not resold or used, directly or indirectly, on humans except in lawful clinical trials and biostudies authorized and regulated by federal law.
    46403. 4641Any distributor claiming exemption from permitting requirements pursuant to this paragraph, and the purchaser and recipient of the prescription drug, shall comply with the recordkeeping requirements of s. 4669499.0121(6)4670.
    46714. 4672The immediate package or container of any active pharmaceutical ingredient distributed into the state that is intended for teaching, testing, research, and development shall bear a label prominently displaying the statement: “Caution: Research, Teaching, or Testing Only - Not for Manufacturing, Compounding, or Resale.”
    4716(c) 4717An 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 s. 4786499.0121(6) 4787must be followed for such transactions.
    4793(d) 4794Persons receiving prescription drugs from a source claimed to be exempt from permitting requirements under this subsection shall maintain on file:
    48151. 4816A record of the FDA establishment registration number, if any;
    48262. 4827The resident state or federal license, registration, or permit that authorizes the source to distribute prescription drugs; and
    48453. 4846A copy of the most recent resident state or FDA inspection report, for all distributors and establishments from whom they purchase or receive prescription drugs under this subsection.
    4874(e) 4875All persons claiming exemption from permitting requirements pursuant to this subsection who engage in the distribution of prescription drugs within or into the state are subject to this part, including ss. 4906499.005 4907and 4908499.0051, 4909and shall make available, within 48 hours, to the department on request all records related to any prescription drugs distributed under this subsection, including those records described in s. 4938499.051(4), 4939regardless of the location where the records are stored.
    4948(f) 4949A person purchasing and receiving a prescription drug from a person claimed to be exempt from licensing requirements pursuant to this subsection shall report to the department in writing within 14 days after receiving any product that is misbranded or adulterated or that fails to meet minimum standards set forth in the official compendium or state or federal good manufacturing practices for identity, purity, potency, or sterility, regardless of whether the product is thereafter rehabilitated, quarantined, returned, or destroyed.
    5028(g) 5029The department may adopt rules to administer this subsection which are necessary for the protection of the public health, safety, and welfare. Failure to comply with the requirements of this subsection, or rules adopted by the department to administer this subsection, is a violation of s. 5075499.005(14), 5076and a knowing failure is a violation of s. 5085499.0051(3)5086.
    5087(h) 5088This subsection does not relieve any person from any requirement prescribed by law with respect to controlled substances as defined in the applicable federal and state laws.
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; s. 4, ch. 2012-37; s. 34, ch. 2012-61; s. 11, ch. 2012-143; s. 88, ch. 2013-15; s. 3, ch. 2014-89; s. 6, ch. 2016-212; s. 6, ch. 2018-95; s. 6, ch. 2019-99.

Note

Note.-

A. Section 11, ch. 2019-99, provides in part that “[i]mplementation of sections 2 through 10 of this act is contingent upon authorization granted under federal law, rule, or approval.” Section 11, ch. 2019-99, was codified as s. 499.02851. Section 12, ch. 2019-99, provides that “[t]his act shall take effect July 1, 2019.”

B. Subject to the contingency as to implementation in s. 11, ch. 2019-99, s. 6, ch. 2019-99, amends subsection (1) and paragraph (2)(c) and adds paragraph (2)(s), to read:

(1) Before 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 nonresident prescription drug repackager;

(e) A prescription drug wholesale distributor;

(f) An out-of-state prescription drug wholesale distributor;

(g) A retail pharmacy drug wholesale distributor;

(h) A restricted prescription drug distributor;

(i) A complimentary drug distributor;

(j) A freight forwarder;

(k) A veterinary prescription drug retail establishment;

(l) A veterinary prescription drug wholesale distributor;

(m) A limited prescription drug veterinary wholesale distributor;

(n) An over-the-counter drug manufacturer;

(o) A device manufacturer;

(p) A cosmetic manufacturer;

(q) A third party logistics provider;

(r) A health care clinic establishment; or

(s) An international prescription drug wholesale distributor.

* * * * *

(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 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 prescription drug manufacturer under this part. The department shall adopt rules for issuing a virtual nonresident prescription drug manufacturer permit to a person who engages in the manufacture of prescription drugs but does not make or take physical possession of any prescription drugs. The rules adopted by the department under this section may exempt virtual nonresident manufacturers from certain establishment, security, and storage requirements set forth in s. 499.0121.

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, an international prescription drug wholesale distributor permit, or third party logistics provider permit pursuant to this section to engage in the distribution of such prescription drugs when required by this part. This subparagraph does not apply to a manufacturer that distributes prescription drugs only for the manufacturer of the prescription drugs where both manufacturers are affiliates.

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 prescription drug distributed 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. A nonresident prescription drug manufacturer that has registered to participate in the International Prescription Drug Importation Program pursuant to this section is not required to provide the list and approval required by subparagraph 2. for prescription drugs imported under that program.

b. To participate as an exporter of prescription drugs into this state under the International Prescription Drug Importation Program established under s. 499.0285, a nonresident prescription drug manufacturer located outside of the United States must register with the Department of Business and Professional Regulation before engaging in any activities under that section. Such manufacturer must be licensed or permitted in a country with which the United States has a current mutual recognition agreement, cooperation agreement, memorandum of understanding, or other federal mechanism recognizing the country’s adherence to current good manufacturing practices for pharmaceutical products.

c. The department shall adopt rules governing the financial responsibility of a nonresident prescription drug manufacturer licensee or permittee. The rules will establish, at a minimum, financial reporting requirements, standards for financial capability to perform the functions governed by the permit, and requirements for ensuring permittees and their contractors can be held accountable for the financial consequences of any act of malfeasance or misfeasance or fraudulent or dishonest act or acts committed by the permittee or its contractors.

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(s) International prescription drug wholesale distributor.-

1. A wholesale distributor located outside of the United States must obtain an international prescription drug wholesale distributor permit to engage in the wholesale exportation and distribution of prescription drugs in the state under the International Prescription Drug Importation Program established in s. 499.0285. The wholesale distributor must be licensed or permitted to operate in a country with which the United States has a mutual recognition agreement, cooperation agreement, memorandum of understanding, or other federal mechanism recognizing the country’s adherence to current good manufacturing practices for pharmaceutical products. The wholesale distributor must maintain at all times a license or permit to engage in the wholesale distribution of prescription drugs in compliance with the laws of the jurisdiction in which it operates. An international prescription drug wholesale distributor permit may not be issued to a wholesale distributor if the jurisdiction in which the wholesale distributor operates does not require a license to engage in the wholesale distribution of prescription drugs.

2. The department shall adopt rules governing the financial responsibility of an international prescription drug wholesale distributor permittee. The rules will establish, at a minimum, financial reporting requirements, standards for financial capability to perform the functions governed by the permit, and requirements for ensuring permittees and their contractors can be held accountable for the financial consequences of any act of malfeasance or misfeasance or fraudulent or dishonest act or acts committed by the permittee or its contractors.

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).

Bills Cite this Section:

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Cited by Court Cases:

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