reglab/statecodes huggingface dataset:
2023 Florida Statutes › Title XXXIII - Regulation of Trade, Commerce, Investments, and Solicitations › Chapter 497 - Funeral, Cemetery, and Consumer Services › Part IV - Preneed Sales (Ss. 497.450-497.468) › 497.460 - Payment of funds upon death of named beneficiary.

497.460 Payment of funds upon death of named beneficiary.—Disbursements of funds discharging any preneed contract fulfilled after September 30, 1993, shall be made by the trustee to the preneed licensee upon receipt of a certified copy of the death certificate of the contract beneficiary or satisfactory evidence as established by rule of the licensing authority that the preneed contract has been performed in whole or in part. However, if the contract is only partially performed, the disbursement shall only cover the fair market value of that portion of the contract performed. In the event of any contract default by the contract purchaser, or in the event that the funeral merchandise or service or burial merchandise or service contracted for is not provided or is not desired by the legally authorized person, the trustee shall return, within 30 days after its receipt of a written request therefor, funds paid on the contract to the preneed licensee or to its assigns, subject to s. 497.459.
History.—s. 9, ch. 28211, 1953; s. 11, ch. 65-393; s. 7, ch. 77-438; s. 2, ch. 78-276; s. 2, ch. 81-318; ss. 8, 31, 32, ch. 83-316; s. 11, ch. 88-139; ss. 100, 122, ch. 93-399; s. 24, ch. 96-400; s. 109, ch. 2004-301; s. 23, ch. 2016-172.
Note.—Former s. 639.14; s. 497.421.
2023 Florida Statutes › Title XXXIII - Regulation of Trade, Commerce, Investments, and Solicitations › Chapter 497 - Funeral, Cemetery, and Consumer Services › Part IV - Preneed Sales (Ss. 497.450-497.468) › 497.463 - Existing merchandise trust funds; proof of compliance with law.

497.463 Existing merchandise trust funds; proof of compliance with law.—The preneed licensee shall present to the licensing authority prior to the implementation of the alternatives provided in s. 497.462 documentation which demonstrates that the existing merchandise trust fund complies with the law and that the elected alternative plan conforms to the requirements of this chapter.
History.—ss. 9, 10, ch. 88-227; s. 1, ch. 89-8; ss. 78, 122, ch. 93-399; s. 112, ch. 2004-301.
Note.—Former s. 497.049; s. 497.427.
2023 Florida Statutes › Title XXXIII - Regulation of Trade, Commerce, Investments, and Solicitations › Chapter 497 - Funeral, Cemetery, and Consumer Services › Part IV - Preneed Sales (Ss. 497.450-497.468) › 497.467 - Acceptability of funeral and burial merchandise.

497.467 Acceptability of funeral and burial merchandise.—Each person who engages in preneed sales of funeral or burial merchandise shall determine, and notify the purchaser in writing prior to the completion of the contract, that the merchandise being considered for purchase will be accepted in the cemetery of the purchaser’s choice. The failure to comply with this chapter shall nullify the agreement, and all moneys paid in shall be returned, notwithstanding the existence of any liquidated damages provision otherwise applicable by contract or statute.
History.—s. 13, ch. 77-438; s. 2, ch. 81-318; ss. 21, 31, 32, ch. 83-316; ss. 108, 122, ch. 93-399; s. 116, ch. 2004-301.
Note.—Former s. 639.21; s. 497.441.
2023 Florida Statutes › Title XXXIII - Regulation of Trade, Commerce, Investments, and Solicitations › Chapter 497 - Funeral, Cemetery, and Consumer Services › Part V - Monument Establishments (Ss. 497.550-497.555) › 497.551 - Renewal of monument establishment licensure.

497.551 Renewal of monument establishment licensure.—
(1) A monument establishment license shall be renewed biennially by the licensee.
(2) A monument establishment licensee shall renew its monument establishment license by payment of a renewal fee established by rule not to exceed $250.
(3) Rules may be adopted providing procedures, forms, and uniform timeframes for monument establishment license renewals.
History.—s. 119, ch. 2004-301; s. 101, ch. 2005-2; s. 41, ch. 2005-155.
2023 Florida Statutes › Title XXXIII - Regulation of Trade, Commerce, Investments, and Solicitations › Chapter 497 - Funeral, Cemetery, and Consumer Services › Part V - Monument Establishments (Ss. 497.550-497.555) › 497.552 - Required facilities.

497.552 Required facilities.—A monument establishment shall at all times have and maintain a full-service place of business at a specific street address or location in Florida complying with the following requirements:
(1) It shall include an office for the conduct of its business including the reception of customers.
(2) It shall include a display area in which is displayed a selection of monuments, markers, and related products for inspection by customers prior to sale.
(3) Its office and display area shall normally be open to the public weekdays during normal business hours.
(4) It shall have facilities on site for inscribing monuments and equipment to deliver and install markers and monuments.
(5) It shall comply with any local government zoning regulations and may not be located on tax-exempt property.
History.—s. 120, ch. 2004-301; s. 42, ch. 2005-155; s. 74, ch. 2018-110.
2023 Florida Statutes › Title XXXIII - Regulation of Trade, Commerce, Investments, and Solicitations › Chapter 497 - Funeral, Cemetery, and Consumer Services › Part V - Monument Establishments (Ss. 497.550-497.555) › 497.555 - Required rules.

497.555 Required rules.—Rules shall be adopted establishing minimum standards for access to all cemeteries by licensed monument establishments for the purpose of delivering and installing markers and monuments. In all cases, cemeteries and monument establishments shall comply with these minimum standards.
History.—s. 123, ch. 2004-301; s. 45, ch. 2005-155.
2023 Florida Statutes › Title XXXIII - Regulation of Trade, Commerce, Investments, and Solicitations › Chapter 497 - Funeral, Cemetery, and Consumer Services › Part VI - Cremation, Crematories, and Direct Disposition (Ss. 497.601-497.609) › 497.601 - Direct disposition; duties.

497.601 Direct disposition; duties.—
(1) Those individuals licensed as direct disposers may perform only those functions set forth below:
(a) Remove human remains from the place of death and store human remains in registered direct disposal establishments.
(b) Secure pertinent information from a legally authorized person in order to complete the death certificate and to file for the necessary permits for disposition.
(c) Obtain the necessary permits for direct disposition and arrange for obituaries and death notices to be placed in newspapers; provided, however, that the name of the direct disposal establishment may not appear in any death notice or obituary if any funeral service, memorial service, or graveside service is to take place and such service is mentioned in the death notice or obituary.
(d) Refrigerate human remains prior to direct disposition and transport human remains to a direct disposal establishment for direct disposition.
(e) Contract with a removal service or refrigeration facility to provide such services or facilities to a direct disposal establishment.
(2) Direct disposers or funeral directors functioning as direct disposers may not, in their capacity as direct disposers, sell, conduct, or arrange for burials, funeral services, memorial services, visitations, or viewings; hold themselves out to the public as funeral directors; or use any name, title, or advertisement that may tend to connote that they are funeral directors. These prohibitions shall apply regardless of the fact that such individuals may be licensed as funeral directors.
(3) Provided that direct disposers limit their activities to those functions set forth in subsection (1), those activities shall not be deemed to constitute funeral directing or embalming or the functions performed by a funeral director or embalmer as otherwise set forth in this chapter.
History.—s. 15, ch. 93-399; s. 67, ch. 94-119; s. 126, ch. 2004-301; s. 29, ch. 2016-172.
Note.—Former s. 470.0165.
2023 Florida Statutes › Title XXXIII - Regulation of Trade, Commerce, Investments, and Solicitations › Chapter 497 - Funeral, Cemetery, and Consumer Services › Part VI - Cremation, Crematories, and Direct Disposition (Ss. 497.601-497.609) › 497.603 - Direct disposers, renewal of license.

497.603 Direct disposers, renewal of license.—
(1) A direct disposer’s license shall be renewed upon receipt of the renewal application and fee set by rule of the licensing authority but not to exceed $500.
(2) The licensing authority shall adopt rules establishing procedures, forms, and a schedule for the biennial renewal of direct disposer licenses. The rules shall require continuing education of up to 6 classroom hours, including, but not limited to, a course on communicable diseases approved by the licensing authority, and may establish criteria for accepting alternative nonclassroom continuing education on an hour-for-hour basis.
History.—ss. 1, 5, ch. 79-231; ss. 2, 3, ch. 81-318; s. 1, ch. 89-8; ss. 17, 122, ch. 93-399; s. 211, ch. 94-119; s. 6, ch. 98-298; s. 27, ch. 2000-356; s. 128, ch. 2004-301; s. 102, ch. 2005-2; s. 47, ch. 2005-155; s. 27, ch. 2010-125.
Note.—Former s. 470.018.
2023 Florida Statutes › Title XXXIII - Regulation of Trade, Commerce, Investments, and Solicitations › Chapter 497 - Funeral, Cemetery, and Consumer Services › Part VI - Cremation, Crematories, and Direct Disposition (Ss. 497.601-497.609) › 497.605 - Direct disposition not funeral directing.

497.605 Direct disposition not funeral directing.—The duties, functions, and services performed by a direct disposer licensee, as provided by this chapter, shall not be deemed to constitute funeral directing or embalming or the duties, functions, or services performed by a funeral director or embalmer as otherwise defined and provided by this chapter.
History.—ss. 1, 5, ch. 79-231; ss. 2, 3, ch. 81-318; s. 1, ch. 89-8; s. 122, ch. 93-399; s. 130, ch. 2004-301.
Note.—Former s. 470.022.
2023 Florida Statutes › Title XXXIII - Regulation of Trade, Commerce, Investments, and Solicitations › Chapter 497 - Funeral, Cemetery, and Consumer Services › Part VI - Cremation, Crematories, and Direct Disposition (Ss. 497.601-497.609) › 497.608 - Liability for unintentional commingling of the residue of the cremation process.

497.608 Liability for unintentional commingling of the residue of the cremation process.—
(1) The Legislature recognizes that the unintentional or incidental commingling of the residue of the cremation of human remains is an inevitable byproduct of the cremation process in a cinerator retort or cremation chamber.
(2) The operator of a cinerator facility shall establish written procedures for the removal of cremated remains, to the extent possible, resulting from the cremation of a human body and the postcremation processing, shipping, packing, or identifying of those remains. The operator of a cinerator facility shall file its written procedures, and any revisions to those written procedures, with the licensing authority for its approval, and the cremation facility shall not be operated unless it has and follows such written procedures approved by the licensing authority; provided, the licensing authority may adopt by rule standard uniform procedures for the removal of such cremated remains, which may be adopted by any cinerator facility in lieu of promulgating, filing, and obtaining approval of procedures. A cinerator facility choosing to utilize standard uniform procedures specified by rule shall file notice of its choice with the licensing authority pursuant to procedures and forms specified by rule.
(3) If an operator follows the procedures set forth in written procedures filed with and approved by the licensing authority, or adopts and follows the standard uniform procedures adopted by the licensing authority, the operator shall not be liable for the unintentional or the incidental commingling of cremated remains resulting from more than one cremation cycle or from postcremation processing, shipping, packing, or identifying those remains.
(4) A copy of the procedures being utilized by a cinerator facility shall be provided by the cinerator facility, upon request, to customers and their representatives, the department, and other legally authorized persons.
History.—s. 133, ch. 2004-301; s. 104, ch. 2005-2; s. 76, ch. 2018-110.
2023 Florida Statutes › Title XXXIII - Regulation of Trade, Commerce, Investments, and Solicitations › Chapter 497 - Funeral, Cemetery, and Consumer Services › Part VI - Cremation, Crematories, and Direct Disposition (Ss. 497.601-497.609) › 497.609 - Liability of direct disposers, direct disposal establishments, funeral directors, funeral establishments, and cinerator facilities regarding cremation.

497.609 Liability of direct disposers, direct disposal establishments, funeral directors, funeral establishments, and cinerator facilities regarding cremation.—If a direct disposer, direct disposal establishment, funeral director, funeral establishment, or cinerator facility is given a copy of the deceased’s declaration of intent to be cremated that is signed by the deceased and the deceased’s human remains are subsequently cremated, or a court order directing the cremation of the deceased’s human remains, no person may make a claim objecting to the cremation against that direct disposer, direct disposal establishment, funeral director, funeral establishment, or cinerator facility. If a direct disposer, direct disposal establishment, funeral director, funeral establishment, or cinerator facility performs a cremation pursuant to the authorization of a legally authorized person who represents that she or he is not aware of any objection to the cremation of the deceased’s human remains by others in the same class of the person making the representation or of any person in a higher priority class, and the deceased’s human remains are subsequently cremated, no person may make a claim objecting to the cremation against that direct disposer, direct disposal establishment, funeral director, funeral establishment, or cinerator facility.
History.—s. 11, ch. 2007-55.
2023 Florida Statutes › Title XXXIII - Regulation of Trade, Commerce, Investments, and Solicitations › Chapter 499 - Florida Drug and Cosmetic Act › Part I - Drugs; Devices; Cosmetics; Household Products (Ss. 499.001-499.067) › 499.001 - Florida Drug and Cosmetic Act; short title.

499.001 Florida Drug and Cosmetic Act; short title.—Sections 499.001-499.94 may be cited as the “Florida Drug and Cosmetic Act.”
History.—s. 34, ch. 82-225; s. 1, ch. 83-265; s. 1, ch. 86-133; ss. 1, 52, ch. 92-69; s. 122, ch. 2014-17; s. 1, ch. 2014-89.
2023 Florida Statutes › Title XXXIII - Regulation of Trade, Commerce, Investments, and Solicitations › Chapter 499 - Florida Drug and Cosmetic Act › Part I - Drugs; Devices; Cosmetics; Household Products (Ss. 499.001-499.067) › 499.002 - Purpose, administration, and enforcement of and exemption from this part.

499.002 Purpose, administration, and enforcement of and exemption from this part.—
(1) This part is intended to:
(a) Safeguard the public health and promote the public welfare by protecting the public from injury by product use and by merchandising deceit involving drugs, devices, and cosmetics.
(b) Provide uniform legislation to be administered so far as practicable in conformity with the provisions of, and regulations issued under the authority of, the Federal Food, Drug, and Cosmetic Act and that portion of the Federal Trade Commission Act which expressly prohibits the false advertisement of drugs, devices, and cosmetics.
(c) Promote thereby uniformity of such state and federal laws, and their administration and enforcement, throughout the United States.
(2) The department shall administer and enforce this part to prevent fraud, adulteration, misbranding, or false advertising in the preparation, manufacture, repackaging, or distribution of drugs, devices, and cosmetics.
(3) For the purpose of any investigation or proceeding conducted by the department under this part, the department may administer oaths, take depositions, issue and serve subpoenas, and compel the attendance of witnesses and the production of books, papers, documents, or other evidence. The department shall exercise this power on its own initiative. Challenges to, and enforcement of, the subpoenas and orders shall be handled as provided in s. 120.569.
(4) Each state attorney, county attorney, or municipal attorney to whom the department or its designated agent reports any violation of this part shall cause appropriate proceedings to be instituted in the proper courts without delay and to be prosecuted in the manner required by law.
(5) This part does not require the department to report, for the institution of proceedings under this part, minor violations of this part when it believes that the public interest will be adequately served in the circumstances by a suitable written notice or warning.
(6) Common carriers engaged in interstate commerce are not subject to this part if they are engaged in the usual course of business as common carriers.
(7) Notwithstanding any other law or local ordinance or regulation to the contrary, the regulation of over-the-counter proprietary drugs and cosmetics is expressly preempted to the state.
History.—s. 34, ch. 82-225; s. 1, ch. 83-265; ss. 2, 3, ch. 86-133; s. 2, ch. 87-50; ss. 2, 4, 6, 48, 49, 50, 52, ch. 92-69; s. 240, ch. 96-410; s. 236, ch. 99-8; s. 1, ch. 2008-207; s. 1, ch. 2020-118.
Note.—Subsection (2) former s. 499.004; subsection (3) former s. 499.0053; subsection (4) former s. 499.07; subsection (5) former s. 499.071; subsection (6) former s. 499.081.
2023 Florida Statutes › Title XXXIII - Regulation of Trade, Commerce, Investments, and Solicitations › Chapter 499 - Florida Drug and Cosmetic Act › Part I - Drugs; Devices; Cosmetics; Household Products (Ss. 499.001-499.067) › 499.008 - Adulterated cosmetics.

499.008 Adulterated cosmetics.—A cosmetic is adulterated:
(1) If it bears or contains any poisonous or deleterious substance that is injurious to users under the conditions of use prescribed in the labeling or advertisement thereof or under such conditions of use as are customary or usual; however, this subsection does not apply to coal-tar hair dye:
(a) The label of which bears the following legend conspicuously displayed thereon: “Caution: This product contains ingredients which may cause skin irritation on certain individuals, and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows; to do so may cause blindness”; and
(b) The labeling of which bears adequate directions for such preliminary testing.
(2) If it consists in whole or in part of any filthy, putrid, or decomposed substance.
(3) If it has been produced, prepared, packed, or held under conditions whereby it could have become contaminated with filth or whereby it could have been rendered injurious to health.
(4) If it is not a hair dye and it is, or it bears or contains, a color additive that is unsafe within the meaning of the federal act.
(5) For the purposes of subsections (1) and (4), the term “hair dye” does not include eyelash dyes or eyebrow dyes.
History.—s. 34, ch. 82-225; s. 1, ch. 83-265; ss. 12, 52, ch. 92-69; s. 8, ch. 2008-207.
2023 Florida Statutes › Title XXXIII - Regulation of Trade, Commerce, Investments, and Solicitations › Chapter 499 - Florida Drug and Cosmetic Act › Part I - Drugs; Devices; Cosmetics; Household Products (Ss. 499.001-499.067) › 499.009 - Misbranded cosmetics.

499.009 Misbranded cosmetics.—A cosmetic is misbranded:
(1) If its labeling is false or misleading in any particular.
(2) If in package form, it does not bear a label containing:
(a) The name and place of business of the manufacturer, packer, or distributor;
(b) An accurate statement of the quantity of the contents in terms of weight, measure, or numerical count; however, under this paragraph reasonable variations are permitted, and the department shall establish by rule exemptions for small packages; and
(c) A declaration of ingredients in descending order of predominance, or as otherwise required by federal law.
(3) If any word, statement, or other information required by or under authority of this part to appear on the label or labeling is not prominently placed thereon with such conspicuousness as compared with other words, statements, designs, or devices in the labeling, and in such terms, as to render the word, statement, or other information likely to be read and understood by an individual under customary conditions of purchase and use.
(4) If its container is so made, formed, or filled as to be misleading.
(5) If it is a color additive, its packaging and labeling are not in conformity with the packaging and labeling requirements applicable to that color additive prescribed under the federal act. This subsection does not apply to packages of color additives that, with respect to their use for cosmetics, are marketed and intended for use only in or on hair dyes.
History.—s. 34, ch. 82-225; s. 1, ch. 83-265; ss. 13, 52, ch. 92-69; s. 9, ch. 2008-207.
2023 Florida Statutes › Title XXXIII - Regulation of Trade, Commerce, Investments, and Solicitations › Chapter 499 - Florida Drug and Cosmetic Act › Part I - Drugs; Devices; Cosmetics; Household Products (Ss. 499.001-499.067) › 499.01201 - Agency for Health Care Administration review and use of statute and rule violation or compliance data.

499.01201 Agency for Health Care Administration review and use of statute and rule violation or compliance data.—Notwithstanding any other provision of law, the Agency for Health Care Administration may not:
(1) Review or use any violation or alleged violation of s. 499.0121(6), or any rules adopted under that section, as a ground for denying or withholding any payment of a Medicaid reimbursement to a pharmacy licensed under chapter 465; or
(2) Review or use compliance with s. 499.0121(6), or any rules adopted under that section, as the subject of any audit of Medicaid-related records held by a pharmacy licensed under chapter 465.
History.—s. 4, ch. 2005-248; s. 12, ch. 2008-207; s. 8, ch. 2016-212.
2023 Florida Statutes › Title XXXIII - Regulation of Trade, Commerce, Investments, and Solicitations › Chapter 499 - Florida Drug and Cosmetic Act › Part I - Drugs; Devices; Cosmetics; Household Products (Ss. 499.001-499.067) › 499.01211 - Drug Wholesale Distributor Advisory Council.

499.01211 Drug Wholesale Distributor Advisory Council.—
(1) There is created the Drug Wholesale Distributor Advisory Council within the department. The council shall meet at least once each calendar quarter. Staff for the council shall be provided by the department. The council shall consist of 12 members who shall serve without compensation. The council shall elect a chairperson and a vice chairperson annually.
(2) The Secretary of Business and Professional Regulation or his or her designee and the Secretary of Health Care Administration or her or his designee shall be members of the council. The Secretary of Business and Professional Regulation shall appoint 10 additional members to the council who shall be appointed to a term of 4 years each, as follows:
(a) Three persons, each of whom is employed by a different prescription drug wholesale distributor permitted under this part which operates nationally as defined in s. 499.003.
(b) One person employed by a prescription drug wholesale distributor permitted under this part as defined in s. 499.003.
(c) One person employed by a retail pharmacy chain located in this state.
(d) One person who is a member of the Board of Pharmacy and is a pharmacist licensed under chapter 465.
(e) One person who is a physician licensed pursuant to chapter 458 or chapter 459.
(f) One person who is an employee of a hospital licensed pursuant to chapter 395 and is a pharmacist licensed pursuant to chapter 465.
(g) One person who is an employee of a pharmaceutical manufacturer.
(h) One person who is an employee of a permitted medical gas manufacturer or medical gas wholesale distributor and who has been recommended by the Compressed Gas Association.
(3) The council shall review this part and the rules adopted to administer this part annually, provide input to the department regarding all proposed rules to administer this part, make recommendations to the department to improve the protection of the prescription drugs and public health, make recommendations to improve coordination with other states’ regulatory agencies and the federal government concerning the wholesale distribution of drugs, and make recommendations to minimize the impact of regulation of the wholesale distribution industry while ensuring protection of the public health.
History.—s. 17, ch. 2003-155; s. 23, ch. 2007-6; s. 105, ch. 2008-6; s. 14, ch. 2008-207; s. 41, ch. 2010-161; s. 4, ch. 2012-143; s. 5, ch. 2014-89; s. 78, ch. 2018-110.
2023 Florida Statutes › Title XXXIII - Regulation of Trade, Commerce, Investments, and Solicitations › Chapter 499 - Florida Drug and Cosmetic Act › Part I - Drugs; Devices; Cosmetics; Household Products (Ss. 499.001-499.067) › 499.023 - New drugs; sale, manufacture, repackaging, distribution.

499.023 New drugs; sale, manufacture, repackaging, distribution.—A person may not sell, offer for sale, hold for sale, manufacture, repackage, distribute, or give away any new drug unless an approved application has become effective under s. 505 of the federal act or unless otherwise permitted by the Secretary of the United States Department of Health and Human Services for shipment in interstate commerce.
History.—s. 34, ch. 82-225; s. 1, ch. 83-265; ss. 26, 52, ch. 92-69.
2023 Florida Statutes › Title XXXIII - Regulation of Trade, Commerce, Investments, and Solicitations › Chapter 499 - Florida Drug and Cosmetic Act › Part I - Drugs; Devices; Cosmetics; Household Products (Ss. 499.001-499.067) › 499.024 - Drug product classification.

499.024 Drug product classification.—The department shall adopt rules to classify drug products intended for use by humans which the United States Food and Drug Administration has not classified in the federal act or the Code of Federal Regulations.
(1) Drug products must be classified as proprietary, prescription, or investigational drugs.
(2) If a product is distributed without required labeling, it is misbranded while held for sale.
(3) Any product that falls under the definition of drug in s. 499.003 may be classified under the authority of this section. This section does not subject portable emergency oxygen inhalators to classification; however, this section does not exempt any person from ss. 499.01 and 499.015.
(4) Any product classified under the authority of this section reverts to the federal classification, if different, upon the federal regulation or act becoming effective.
(5) The department may by rule reclassify drugs subject to this part when such classification action is necessary to protect the public health.
(6) The department may adopt rules that exempt from any labeling or packaging requirements of this part drugs classified under this section if those requirements are not necessary to protect the public health.
History.—s. 9, ch. 88-159; s. 1, ch. 89-296; ss. 27, 52, ch. 92-69; s. 589, ch. 97-103; s. 42, ch. 2000-242; s. 13, ch. 2000-326; s. 61, ch. 2006-1; s. 106, ch. 2008-6; s. 19, ch. 2008-207; s. 5, ch. 2012-143; s. 37, ch. 2014-89.
2023 Florida Statutes › Title XXXIII - Regulation of Trade, Commerce, Investments, and Solicitations › Chapter 499 - Florida Drug and Cosmetic Act › Part I - Drugs; Devices; Cosmetics; Household Products (Ss. 499.001-499.067) › 499.025 - Drug products in finished, solid, oral dosage form; identification requirements.

499.025 Drug products in finished, solid, oral dosage form; identification requirements.—
(1) A drug product in finished, solid, oral dosage form for which a prescription is required by federal or state law may not be manufactured or distributed within this state unless it is clearly and prominently marked or imprinted with an individual symbol, number, company name, words, letters, marking, or national drug code, or any combination thereof, that identifies the drug product and the manufacturer or distributor of the drug product which has the ability to respond to requests for information regarding the drug product.
(2) A manufacturer or distributor must make available to the department on request descriptive material that identifies each current imprint used by the manufacturer.
(3) The department, upon application by a manufacturer, may exempt a particular drug product from the requirements of subsection (1) on the ground that imprinting is not feasible because of the size, texture, or other unique characteristic of the drug product.
(4) This section does not apply to drug products compounded by a pharmacist licensed under chapter 465 in a pharmacy operating under a permit issued by the Board of Pharmacy.
(5) The department shall adopt rules for implementing this section.
History.—s. 34, ch. 82-225; s. 1, ch. 83-265; s. 22, ch. 86-256; ss. 28, 52, ch. 92-69; s. 18, ch. 2000-326.
2023 Florida Statutes › Title XXXIII - Regulation of Trade, Commerce, Investments, and Solicitations › Chapter 499 - Florida Drug and Cosmetic Act › Part I - Drugs; Devices; Cosmetics; Household Products (Ss. 499.001-499.067) › 499.02851 - Federal arrangement to operate a pilot program for importing prescription drugs.

499.02851 Federal arrangement to operate a pilot program for importing prescription drugs.—Notwithstanding the Federal Food, Drug, and Cosmetic Act, the Department of Business and Professional Regulation, in collaboration with the Department of Health, shall negotiate a federal arrangement to operate a pilot program for importing prescription drugs into this state. The proposal to operate such a pilot program shall demonstrate that the program sets safety standards consistent with the current federal requirements for the manufacturing and distribution of prescription drugs; limits the importation of prescription drugs under the program to entities licensed or permitted by the state to manufacture, distribute, or dispense prescription drugs; and includes inspection and enforcement authority. Implementation of sections 2 through 10 of this act is contingent upon authorization granted under federal law, rule, or approval. The department shall notify the President of the Senate, the Speaker of the House of Representatives, and the relevant committees of the Senate and the House of Representatives before implementation of the pilot program. The department shall submit to all parties a proposal for program implementation and program funding.
History.—s. 11, ch. 2019-99.
2023 Florida Statutes › Title XXXIII - Regulation of Trade, Commerce, Investments, and Solicitations › Chapter 499 - Florida Drug and Cosmetic Act › Part I - Drugs; Devices; Cosmetics; Household Products (Ss. 499.001-499.067) › 499.03 - Possession of certain drugs without prescriptions unlawful; exemptions and exceptions.

499.03 Possession of certain drugs without prescriptions unlawful; exemptions and exceptions.—
(1) A person may not possess, or possess with intent to sell, dispense, or deliver, any habit-forming, toxic, harmful, or new drug subject to s. 499.003(32), or prescription drug as defined in s. 499.003(40), unless the possession of the drug has been obtained by a valid prescription of a practitioner licensed by law to prescribe the drug. However, this section does not apply to the delivery of such drugs to persons included in any of the classes named in this subsection, or to the agents or employees of such persons, for use in the usual course of their businesses or practices or in the performance of their official duties, as the case may be; nor does this section apply to the possession of such drugs by those persons or their agents or employees for such use:
(a) A licensed pharmacist or any person under the licensed pharmacist’s supervision while acting within the scope of the licensed pharmacist’s practice;
(b) A licensed practitioner authorized by law to prescribe prescription drugs or any person under the licensed practitioner’s supervision while acting within the scope of the licensed practitioner’s practice;
(c) A qualified person who uses prescription drugs for lawful research, teaching, or testing, and not for resale;
(d) A licensed hospital or other institution that procures such drugs for lawful administration or dispensing by practitioners;
(e) An officer or employee of a federal, state, or local government; or
(f) A person that holds a valid permit issued by the department pursuant to this part which authorizes that person to possess prescription drugs.
(2) The possession of a drug under subsection (1) by any person not exempted under this section, which drug is not properly labeled to indicate that possession is by a valid prescription of a practitioner licensed by law to prescribe such drug, is prima facie evidence that such possession is unlawful.
(3) Violation of subsection (1) is a misdemeanor of the second degree, punishable as provided in s. 775.082 or s. 775.083, except that possession with the intent to sell, dispense, or deliver is a third degree felony, punishable as provided in s. 775.082, s. 775.083, or s. 775.084.
(4) The department may adopt rules regarding persons engaged in lawful teaching, research, or testing who possess prescription drugs and may issue letters of exemption to facilitate the lawful possession of prescription drugs under this section.
History.—s. 34, ch. 82-225; s. 1, ch. 83-265; s. 5, ch. 84-115; s. 75, ch. 87-243; ss. 30, 52, ch. 92-69; s. 37, ch. 98-151; s. 43, ch. 2000-242; s. 14, ch. 2000-326; s. 19, ch. 2001-63; s. 89, ch. 2004-5; s. 22, ch. 2008-207; s. 42, ch. 2010-161; s. 11, ch. 2016-212.
2023 Florida Statutes › Title XXXIII - Regulation of Trade, Commerce, Investments, and Solicitations › Chapter 499 - Florida Drug and Cosmetic Act › Part I - Drugs; Devices; Cosmetics; Household Products (Ss. 499.001-499.067) › 499.032 - Phenylalanine; prescription required.

499.032 Phenylalanine; prescription required.—Phenylalanine restricted formula is declared to be a prescription drug and may be dispensed only upon the prescription of a practitioner authorized by law to prescribe prescription drugs.
History.—s. 34, ch. 82-225; s. 1, ch. 83-265; ss. 31, 52, ch. 92-69; s. 23, ch. 2008-207.
2023 Florida Statutes › Title XXXIII - Regulation of Trade, Commerce, Investments, and Solicitations › Chapter 499 - Florida Drug and Cosmetic Act › Part I - Drugs; Devices; Cosmetics; Household Products (Ss. 499.001-499.067) › 499.033 - Ephedrine; prescription required.

499.033 Ephedrine; prescription required.—Ephedrine is declared to be a prescription drug.
(1) Except as provided in subsection (2), any product that contains any quantity of ephedrine, a salt of ephedrine, an optical isomer of ephedrine, or a salt of an optical isomer of ephedrine may be dispensed only upon the prescription of a duly licensed practitioner authorized by the laws of the state to prescribe prescription drugs.
(2) A product containing ephedrine described in paragraphs (a)-(e) is exempt from subsection (1) if it may lawfully be sold over the counter without a prescription under the federal act; is labeled and marketed in a manner consistent with the pertinent United States Food and Drug Administration Over-the-Counter Tentative Final or Final Monograph; and is manufactured and distributed for legitimate medicinal use in a manner that reduces or eliminates the likelihood of abuse, when considered in the context with: the package sizes and the manner of packaging of the drug product; the name and labeling of the product; the manner of distribution, advertising, and promotion of the product; the duration, scope, health significance, and societal cost of abuse of the particular product; the need to provide medically important ephedrine-containing therapies to the public for United States Food and Drug Administration approved indications on an unrestricted, over-the-counter basis; and other facts as may be relevant to and consistent with public health and safety.
(a) Solid oral dosage forms that combine active ingredients in the following ranges for each dosage unit:
1. Theophylline (100-130mg), ephedrine (12.5-24mg).
2. Theophylline (60-100mg), ephedrine (12.5-24mg), guaifenesin (200-400mg).
3. Ephedrine (12.5-25mg), guaifenesin (200-400mg).
4. Phenobarbital (not greater than 8mg) in combination with the ingredients of subparagraph 1. or subparagraph 2.
(b) Liquid oral dosage forms that combine active ingredients in the following ranges for each (5ml) dose:
1. Theophylline (not greater than 45mg), ephedrine (not greater than 36mg), guaifenesin (not greater than 100mg), phenobarbital (not greater than 12mg).
2. Phenylephrine (not greater than 5mg), ephedrine (not greater than 5mg), chlorpheniramine (not greater than 2mg), dextromethorphan (not greater than 10mg), ammonium chloride (not greater than 40mg), ipecac fluid extract (not greater than 0.005ml).
(c) Anorectal preparations containing less than 5 percent ephedrine.
(d) Nasal decongestant compounds, mixtures, or preparations containing 0.5 percent or less ephedrine.
(e) Any drug product containing ephedrine that is marketed pursuant to an approved new drug application or legal equivalent under the federal act.
(3) The department may implement this section by rule.
History.—s. 7, ch. 94-309; s. 1, ch. 95-415; s. 61, ch. 2003-1; s. 24, ch. 2008-207.
2023 Florida Statutes › Title XXXIII - Regulation of Trade, Commerce, Investments, and Solicitations › Chapter 499 - Florida Drug and Cosmetic Act › Part I - Drugs; Devices; Cosmetics; Household Products (Ss. 499.001-499.067) › 499.035 - Dimethyl sulfoxide (DMSO); labeling and advertising.

499.035 Dimethyl sulfoxide (DMSO); labeling and advertising.—
(1) Dimethyl sulfoxide (DMSO) not approved for drug use must be clearly marked in at least 12-point boldfaced type: “May be unsafe. Not approved for human use.”
(2) All advertisements for the sale of dimethyl sulfoxide (DMSO) not approved for drug use must contain, within the advertisement and in bold lettering, the following statement: “Warning. May be unsafe. Not approved for human use.”
History.—s. 34, ch. 82-225; s. 26, ch. 82-402; s. 1, ch. 83-265; ss. 32, 52, ch. 92-69; ss. 1, 5, 8, ch. 94-309.
2023 Florida Statutes › Title XXXIII - Regulation of Trade, Commerce, Investments, and Solicitations › Chapter 499 - Florida Drug and Cosmetic Act › Part I - Drugs; Devices; Cosmetics; Household Products (Ss. 499.001-499.067) › 499.039 - Sale, distribution, or transfer of harmful chemical substances; penalties; authority for enforcement.

499.039 Sale, distribution, or transfer of harmful chemical substances; penalties; authority for enforcement.—It is unlawful for a person to sell, deliver, or give to a person under the age of 18 years any compound, liquid, or chemical containing toluol, hexane, trichloroethylene, acetone, toluene, ethyl acetate, methyl ethyl ketone, trichloroethane, isopropanol, methyl isobutyl ketone, ethylene glycol monomethyl ether acetate, cyclohexanone, nitrous oxide, diethyl ether, alkyl nitrites (butyl nitrite), or any similar substance for the purpose of inducing by breathing, inhaling, or ingesting a condition of intoxication or which is intended to distort or disturb the auditory, visual, or other physical or mental processes.
(1) On the first violation of this section, the department may issue a warning according to s. 499.002(5), if the violation has not caused temporary or permanent physical or mental injury to the user.
(2) If any violation of this section has caused temporary or permanent physical or mental injury to the user, the department may, pursuant to chapter 120, impose fines according to s. 499.066 and may report any violation to the appropriate state attorney for prosecution.
(3) The department shall adopt rules to implement this section.
History.—s. 12, ch. 86-133; s. 1, ch. 89-296; ss. 33, 52, ch. 92-69; s. 239, ch. 99-8; s. 25, ch. 2008-207.
2023 Florida Statutes › Title XXXIII - Regulation of Trade, Commerce, Investments, and Solicitations › Chapter 499 - Florida Drug and Cosmetic Act › Part I - Drugs; Devices; Cosmetics; Household Products (Ss. 499.001-499.067) › 499.04 - Fee authority.

499.04 Fee authority.—The department may collect fees for all drug, device, and cosmetic applications, permits, product registrations, and free-sale certificates. The total amount of fees collected from all permits, applications, product registrations, and free-sale certificates must be adequate to fund the expenses incurred by the department in carrying out this part. The department shall, by rule, establish a schedule of fees that are within the ranges provided in this section and shall adjust those fees from time to time based on the costs associated with administering this part. The fees are payable to the department to be deposited into the Professional Regulation Trust Fund for the sole purpose of carrying out this part.
History.—s. 34, ch. 82-225; s. 115, ch. 83-218; s. 1, ch. 83-265; ss. 34, 52, ch. 92-69; s. 15, ch. 2000-326; s. 26, ch. 2008-207; s. 13, ch. 2012-143.
2023 Florida Statutes › Title XXXIII - Regulation of Trade, Commerce, Investments, and Solicitations › Chapter 499 - Florida Drug and Cosmetic Act › Part I - Drugs; Devices; Cosmetics; Household Products (Ss. 499.001-499.067) › 499.05 - Rules.

499.05 Rules.—
(1) The department shall adopt rules to implement and enforce this chapter with respect to:
(a) The definition of terms used in this chapter, and used in the rules adopted under this chapter, when the use of the term is not its usual and ordinary meaning.
(b) Labeling requirements for drugs, devices, and cosmetics.
(c) The establishment of fees authorized in this chapter.
(d) The identification of permits that require an initial application and onsite inspection or other prerequisites for permitting which demonstrate that the establishment and person are in compliance with the requirements of this chapter.
(e) The application processes and forms for product registration.
(f) Procedures for requesting and issuing certificates of free sale.
(g) Inspections and investigations conducted under s. 499.051 or s. 499.93, and the identification of information claimed to be a trade secret and exempt from the public records law as provided in s. 499.051(7).
(h) The establishment of a range of penalties, as provided in s. 499.066; requirements for notifying persons of the potential impact of a violation of this chapter; and a process for the uncontested settlement of alleged violations.
(i) Additional conditions that qualify as an emergency medical reason under s. 499.003(48)(b)2. or s. 499.82.
(j) The protection of the public health, safety, and welfare regarding good manufacturing practices that manufacturers and repackagers must follow to ensure the safety of the products.
(k) Information required from each retail establishment pursuant to s. 499.012(3) or s. 499.83(2)(c), including requirements for prescriptions or orders.
(l) The recordkeeping, storage, and handling with respect to each of the distributions of prescription drugs specified in s. 499.003(48)(a)-(v) or s. 499.82(14).
(m) Wholesale distributor reporting requirements of s. 499.0121(14).
(n) Wholesale distributor credentialing and distribution requirements of s. 499.0121(15).
(2) With respect to products in interstate commerce, those rules must not be inconsistent with rules and regulations of federal agencies unless specifically otherwise directed by the Legislature.
(3) The department shall adopt rules regulating recordkeeping for and the storage, handling, and distribution of medical devices and over-the-counter drugs to protect the public from adulterated products.
History.—s. 34, ch. 82-225; s. 1, ch. 83-265; s. 6, ch. 84-115; s. 88, ch. 85-81; s. 4, ch. 86-133; ss. 17, 18, 36, ch. 92-69; ss. 2, 5, 8, ch. 94-309; ss. 31, 34, 38, ch. 98-151; s. 172, ch. 99-397; ss. 39, 44, ch. 2000-242; s. 20, ch. 2001-63; s. 32, ch. 2001-89; ss. 13, 14, 18, ch. 2003-155; ss. 87, 90, ch. 2004-5; s. 28, ch. 2008-207; s. 43, ch. 2010-161; s. 19, ch. 2011-141; s. 7, ch. 2014-89; s. 12, ch. 2016-212.
Note.—Paragraph (1)(k) former s. 499.013(3); paragraph (1)(l) former s. 499.0122(2)(b); paragraph (1)(m) former s. 499.012(12).
2023 Florida Statutes › Title XXXIII - Regulation of Trade, Commerce, Investments, and Solicitations › Chapter 499 - Florida Drug and Cosmetic Act › Part I - Drugs; Devices; Cosmetics; Household Products (Ss. 499.001-499.067) › 499.052 - Records of interstate shipment.

499.052 Records of interstate shipment.—For the purpose of enforcing this part, carriers engaged in interstate commerce and persons receiving drugs, devices, or cosmetics in interstate commerce must, upon the request, in the manner set out below, by an officer or employee duly designated by the department, permit the officer or employee to have access to and to copy all records showing the movement in interstate commerce of any drug, device, or cosmetic, and the quantity, shipper, and consignee thereof.
History.—s. 34, ch. 82-225; s. 1, ch. 83-265; ss. 38, 52, ch. 92-69; s. 30, ch. 2008-207.
2023 Florida Statutes › Title XXXIII - Regulation of Trade, Commerce, Investments, and Solicitations › Chapter 499 - Florida Drug and Cosmetic Act › Part I - Drugs; Devices; Cosmetics; Household Products (Ss. 499.001-499.067) › 499.055 - Reports and dissemination of information by department.

499.055 Reports and dissemination of information by department.—
(1) The department may cause to be published from time to time reports summarizing all judgments, decrees, and court orders that have been rendered under ss. 499.001-499.79, including the nature of any charges and the dispositions of the charges.
(2) The department may also cause to be disseminated such information regarding drugs, devices, and cosmetics as considered necessary in the interest of public health and the protection of consumers against fraud.
(3) This section does not prohibit the department from collecting, reporting, and illustrating the results of its investigations.
(4) The department shall publish on the department’s website and update at least monthly:
(a) A list of the prescription drug wholesale distributors, out-of-state prescription drug wholesale distributors, and retail pharmacy drug wholesale distributors against whom the department has initiated enforcement action pursuant to this part to suspend or revoke a permit, seek an injunction, or otherwise file an administrative complaint and the permit number of each such wholesale distributor.
(b) A list of the prescription drug wholesale distributors, out-of-state prescription drug wholesale distributors, and retail pharmacy drug wholesale distributors to which the department has issued a permit, including the date on which each permit will expire.
(c) A list of the prescription drug wholesale distributor, out-of-state prescription drug wholesale distributor, and retail pharmacy drug wholesale distributor permits that have been returned to the department, were suspended, were revoked, have expired, or were not renewed in the previous year.
History.—s. 34, ch. 82-225; s. 1, ch. 83-265; s. 6, ch. 86-133; ss. 39, 52, ch. 92-69; s. 22, ch. 2003-155; s. 31, ch. 2008-207.
2023 Florida Statutes › Title XXXIII - Regulation of Trade, Commerce, Investments, and Solicitations › Chapter 499 - Florida Drug and Cosmetic Act › Part I - Drugs; Devices; Cosmetics; Household Products (Ss. 499.001-499.067) › 499.057 - Expenses and salaries.

499.057 Expenses and salaries.—Except as otherwise provided in the General Appropriations Act, all expenses and salaries shall be paid out of the Professional Regulation Trust Fund.
History.—s. 34, ch. 82-225; s. 1, ch. 83-265; ss. 40, 52, ch. 92-69; s. 564, ch. 2003-261; s. 14, ch. 2012-143.