reglab/housing_qa huggingface dataset:
FL Stat § 499.832 (2021)
2021 Florida Statutes|Title XXXIII - Regulation of Trade, Commerce, Investments, and Solicitations|Chapter 499 - Florida Drug and Cosmetic Act|Part III - Medical Gas (Ss. 499.81-499.94)|499.832 - Expiration and renewal of a permit.

499.832 Expiration and renewal of a permit.—(1) A permit issued under this part automatically expires 2 years after the last day of the month in which the permit was originally issued.(2) A permit issued under this part may be renewed by submitting an application for renewal on a form furnished by the department and paying the appropriate fee. The application for renewal must contain a statement by the applicant attesting that the information is true and correct. Upon approval of a renewal application by the department and payment of the required renewal fee, the department shall renew a permit issued under this part pursuant to the rules adopted under this part.(3) A renewal application may be accepted up to 60 days after the expiration date of the permit if, along with the permit renewal fee, the applicant submits an additional renewal delinquent fee of $100. A permit that expired more than 60 days before a renewal application was submitted or postmarked may not be renewed.(4) Failure to renew a permit in accordance with this section precludes future renewal. If a permit has expired and cannot be renewed, the person, entity, or establishment holding the permit must cease all permit-related activities. In order to engage in such activities, the person, entity, or establishment must submit an application for a new permit, pay the applicable application fee, the initial permit fee, and all applicable penalties, and be issued a new permit by the department before engaging in an activity that requires a permit under this part.(5) The department shall adopt rules to administer this section, including setting a reasonable fee for a renewal application.History.—s. 17, ch. 2014-89.
FL Stat § 499.834 (2021)
2021 Florida Statutes|Title XXXIII - Regulation of Trade, Commerce, Investments, and Solicitations|Chapter 499 - Florida Drug and Cosmetic Act|Part III - Medical Gas (Ss. 499.81-499.94)|499.834 - Minimum qualifications.

499.834 Minimum qualifications.—The department shall consider all of the following factors in determining eligibility for, and renewal of, a permit for a person or entity under this part:(1) A finding by the department that the applicant has violated or been disciplined by a regulatory agency in any state for violating a federal, state, or local law relating to prescription drugs.(2) Felony convictions of the applicant under a federal, state, or local law.(3) The applicant’s past experience in the manufacture, retail, or distribution of medical gases.(4) False or fraudulent material provided by the applicant in an application made in connection with the manufacturing, retailing, or distribution of prescription drugs.(5) Any suspension, sanction, or revocation by a federal, state, or local government against a license or permit currently or previously held by the applicant or its owners for violations of a federal, state, or local law regarding prescription drugs.(6) Compliance with previously granted licenses or permits.(7) Compliance with the requirements that distributors or retailers of medical gases maintain records and make records available to the department licensing authority or federal, state, or local law enforcement officials.(8) Other factors or qualifications the department has established in rule that are relevant to and consistent with the public health and safety.History.—s. 19, ch. 2014-89.
FL Stat § 499.84 (2021)
2021 Florida Statutes|Title XXXIII - Regulation of Trade, Commerce, Investments, and Solicitations|Chapter 499 - Florida Drug and Cosmetic Act|Part III - Medical Gas (Ss. 499.81-499.94)|499.84 - Minimum requirements for the storage and handling of medical gases.

499.84 Minimum requirements for the storage and handling of medical gases.—(1) A facility where a medical gas is received, stored, warehoused, handled, held, offered, marketed, displayed, or transported, to avoid any negative effect on the identity, strength, quality, or purity of the medical gas, must:(a) Be of suitable construction to ensure that medical gases are maintained in accordance with the product labeling of the medical gas or in compliance with the USP-NF;(b) Be of suitable size and construction to facilitate cleaning, maintenance, and proper permitted operations;(c) Have adequate storage areas with appropriate lighting, ventilation, space, equipment, and security conditions;(d) Have a quarantined area for storage of medical gases that are suspected of being misbranded, adulterated, or otherwise unfit for distribution;(e) Be maintained in an orderly condition;(f) Be located in a commercial location and not in a personal dwelling or residence location, except for a personal dwelling location used for on-call delivery of oxygen USP for home care use if the person providing on-call delivery is employed by or acting under a written contract with an entity that holds a medical oxygen retailer permit;(g) Provide for the secure and confidential storage of patient information, if applicable, with restricted access and policies and procedures to protect the integrity and confidentiality of patient information; and(h) Provide and maintain appropriate inventory controls to detect and document any theft of nitrous oxide.(2) Medical gas shall be stored under appropriate conditions in accordance with the manufacturer’s recommendations on product labeling and department rules or, in the absence of rules, in accordance with applicable industry standards.(3) Medical gas shall be packaged in accordance with official compendium standards, such as the USP-NF.History.—s. 20, ch. 2014-89; s. 63, ch. 2015-2.
FL Stat § 499.85 (2021)
2021 Florida Statutes|Title XXXIII - Regulation of Trade, Commerce, Investments, and Solicitations|Chapter 499 - Florida Drug and Cosmetic Act|Part III - Medical Gas (Ss. 499.81-499.94)|499.85 - Security.

499.85 Security.—(1) A permitholder that has a facility used for the distribution or retailing of medical gases shall protect such gases from unauthorized access by implementing all of the following security measures:(a) Keeping access from outside the premises well controlled and to a minimum.(b) Ensuring the outside perimeter of the premises is well lit.(c) Limiting access into areas where medical gases are held to authorized personnel.(d) Equipping all facilities with a fence or other system to detect or deter entry after hours.(2) A facility used for distributing or retailing medical gases shall be equipped with a system that provides suitable protection against theft, including, if appropriate, protection against theft of computers or electronic records and the protection of the integrity and confidentiality of data and documents.(3) A facility used for wholesale distribution of medical gases shall be equipped with inventory management and control systems that protect against, detect, and document any instances of theft of nitrous oxide.(4) If a wholesale distributor uses electronic distribution records, the wholesale distributor shall employ, train, and document the training of personnel in the proper use of such technology and equipment.(5) Vehicles used for on-call delivery of oxygen USP and oxygen-related equipment for home care use by home care providers may be parked at a place of residence and must be locked and equipped with an audible alarm when not attended.(6) The department shall adopt rules that govern the distribution of medical oxygen for emergency use by persons authorized to receive emergency use oxygen. Unless the laws of this state specifically direct otherwise, such rules must be consistent with federal regulations, including the labeling requirements of oxygen under the federal act. Such rules may not be inconsistent with part III of chapter 401 or rules adopted thereunder.History.—s. 21, ch. 2014-89.
FL Stat § 499.86 (2021)
2021 Florida Statutes|Title XXXIII - Regulation of Trade, Commerce, Investments, and Solicitations|Chapter 499 - Florida Drug and Cosmetic Act|Part III - Medical Gas (Ss. 499.81-499.94)|499.86 - Examination of materials.

499.86 Examination of materials.—(1) A wholesale distributor must visually examine a medical gas container upon receipt from the manufacturer in order to identify the medical gas stored within and to determine if the container has been damaged or is otherwise unfit for distribution. Such examination must occur in a manner that would reveal damage to the container which could suggest possible adulteration or misbranding.(2) A medical gas container that is found to be damaged or otherwise unfit pursuant to subsection (1) must be quarantined from the stock of medical gas until a determination is made that the medical gas in question is not misbranded or adulterated.(3) An outgoing shipment must be inspected to identify the medical gases in the shipment to ensure that medical gas containers that have been damaged in storage or held under improper conditions are not distributed or dispensed.(4) A wholesale distributor must review records documenting the acquisition of medical gas upon receipt for accuracy and completeness.History.—s. 22, ch. 2014-89.
FL Stat § 499.87 (2021)
2021 Florida Statutes|Title XXXIII - Regulation of Trade, Commerce, Investments, and Solicitations|Chapter 499 - Florida Drug and Cosmetic Act|Part III - Medical Gas (Ss. 499.81-499.94)|499.87 - Returned, damaged, and outdated medical gas.

499.87 Returned, damaged, and outdated medical gas.—(1) A medical gas that has left the control of the wholesale distributor may be returned to the wholesale distributor or manufacturer from which it was acquired, but may not be resold as a medical gas unless it is reprocessed by a manufacturer using proper and adequate controls to ensure the identity, strength, quality, and purity of the reprocessed medical gas.(2) A medical gas that has been subjected to improper conditions, such as a fire, accident, or natural disaster, may not be salvaged or reprocessed.(3) A medical gas, including its container, which is damaged, misbranded, or adulterated must be quarantined from other medical gases until it is destroyed or returned to the manufacturer or wholesale distributor from which it was acquired. External contamination of a medical gas container or closure system which does not impact the integrity of the medical gas is not considered damaged or adulterated for purposes of this subsection. If a medical gas is adulterated or misbranded or suspected of being adulterated or misbranded, notice shall be provided to the manufacturer or wholesale distributor from which the medical gas was acquired and to the appropriate boards and federal regulatory bodies.(4) A medical gas container that has been opened or used but is not adulterated or misbranded is considered empty and must be quarantined from nonempty medical gas containers and returned to the manufacturer or wholesale distributor from which it was acquired for destruction or reprocessing.(5) A medical gas, its container, or its associated documentation or labeling that is suspected of being used in criminal activity must be retained until its disposition is authorized by the department or an applicable law enforcement agency.History.—s. 23, ch. 2014-89.
FL Stat § 499.88 (2021)
2021 Florida Statutes|Title XXXIII - Regulation of Trade, Commerce, Investments, and Solicitations|Chapter 499 - Florida Drug and Cosmetic Act|Part III - Medical Gas (Ss. 499.81-499.94)|499.88 - Due diligence.

499.88 Due diligence.—(1) A wholesale distributor shall obtain, before the initial acquisition of medical gas, the following information from the supplying wholesale distributor or manufacturer:(a) If a manufacturer is distributing to a wholesale distributor, evidence that the manufacturer is registered and the medical gas is listed with the United States Food and Drug Administration;(b) If a wholesale distributor is distributing to a wholesale distributor, evidence that the wholesale distributor supplying the medical gas is legally authorized to distribute medical gas within or into the state;(c) The name of the responsible facility contact person for the supplying manufacturer or wholesale distributor; and(d) Certification that the manufacturer’s or wholesale distributor’s policies and procedures comply with this part.(2) A wholesale distributor is exempt from obtaining the information from a manufacturer, as required under subsection (1), if the manufacturer is registered with the United States Food and Drug Administration in accordance with s. 510 of the federal act and the manufacturer provides:(a) Proof of such registration; and(b) Proof of inspection by the United States Food and Drug Administration or other regulatory body within the past 3 years demonstrating substantial compliance with current good manufacturing practices applicable to medical gases.(3) A manufacturer or wholesale distributor that distributes to or acquires medical gas from another wholesale distributor shall provide to or obtain from the distributing or acquiring manufacturer or distributor the information required by s. 499.89(1), as applicable.History.—s. 24, ch. 2014-89.
FL Stat § 499.89 (2021)
2021 Florida Statutes|Title XXXIII - Regulation of Trade, Commerce, Investments, and Solicitations|Chapter 499 - Florida Drug and Cosmetic Act|Part III - Medical Gas (Ss. 499.81-499.94)|499.89 - Recordkeeping.

499.89 Recordkeeping.—(1) A permitholder under this part shall establish and maintain a record of transactions regarding the receipt and the distribution, or other disposition, of medical gases, as applicable. Such records constitute an audit trail and must contain information sufficient to perform a recall of medical gas in compliance with 21 C.F.R. ss. 211.196 and 820.160(b). Such records must include all of the following information, which may be kept in two separate documents, one related to the distribution of medical gas and the other related to the receipt of medical gas:(a) The dates of receipt and distribution or other disposition of the medical gas.(b) The name, address, and license or permit number and its expiration date for the person or entity purchasing the medical gas from the wholesale distributor.(c) The name, address, and license or permit number and its expiration date for the person or entity receiving the medical gas, if different from the information required under paragraph (b).(d) Information sufficient to perform a recall of all medical gas received, distributed, or dispensed.(2) Such records shall be made available for inspection and copying by an authorized official of any federal, state, or local governmental agency for a period of:(a) Three years following the distribution date of high pressure medical gases.(b) Two years following the distribution date for cryogenic or refrigerated liquid medical gases.(3) Records kept at the inspection site or that can be immediately retrieved by computer or other electronic means shall be readily available for authorized inspection during the retention period. Records kept at a central location apart from the inspection site and not electronically retrievable shall be made available for inspection within 2 working days of a request by an authorized official of any state or federal governmental agency charged with enforcement of these rules.(4) A wholesale distributor shall maintain records sufficient to aid in the mandatory reporting of any theft, suspected theft, or other significant loss of nitrous oxide to the department and other appropriate law enforcement agencies.History.—s. 25, ch. 2014-89; s. 16, ch. 2016-212.
FL Stat § 499.90 (2021)
2021 Florida Statutes|Title XXXIII - Regulation of Trade, Commerce, Investments, and Solicitations|Chapter 499 - Florida Drug and Cosmetic Act|Part III - Medical Gas (Ss. 499.81-499.94)|499.90 - Policies and procedures.

499.90 Policies and procedures.—A wholesale distributor shall establish, maintain, and adhere to written policies and procedures for the receipt, security, storage, transport, shipping, and distribution of medical gases and shall establish, maintain, and adhere to procedures for maintaining inventories; for identifying, recording, and reporting losses or thefts; and for correcting all errors and inaccuracies in inventories associated with nitrous oxide. A wholesale distributor shall include in its written policies and procedures all of the following:(1) A procedure for handling recalls and withdrawals of medical gas. Such procedure must deal with recalls and withdrawals due to:(a) Action initiated at the request of the United States Food and Drug Administration or any federal, state, or local law enforcement or other government agency, including the department; or(b) Voluntary action by a manufacturer of medical gases to remove defective or potentially defective medical gases from the market.(2) A procedure that includes preparation for, protection against, and responding to a crisis that affects the security or operation of a facility that stores medical gases in the event of a strike; a fire, flood, or other natural disaster; or other local, state, or national emergency.(3) A procedure for reporting criminal or suspected criminal activity involving the inventory of nitrous oxide to the department and to applicable law enforcement agencies within 3 business days after becoming aware of the criminal or suspected criminal activity.History.—s. 26, ch. 2014-89.
FL Stat § 499.92 (2021)
2021 Florida Statutes|Title XXXIII - Regulation of Trade, Commerce, Investments, and Solicitations|Chapter 499 - Florida Drug and Cosmetic Act|Part III - Medical Gas (Ss. 499.81-499.94)|499.92 - Criminal acts.

499.92 Criminal acts.—(1) A person commits a felony of the third degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084, if he or she:(a) Adulterates or misbrands a medical gas with intent to defraud or deceive;(b) Knowingly purchases or receives a medical gas from a person not legally authorized to distribute or dispense medical gas;(c) Knowingly engages in the wholesale distribution of, or sells, barters, brokers, or transfers, a medical gas to a person not legally authorized to purchase or receive medical gas in the jurisdiction in which the person receives the medical gas. A permitted wholesale distributor that provides oxygen to a permitted medical oxygen retail establishment that is out of compliance with only the change of location notice requirement under s. 499.833(3)(a) does not commit a violation of this paragraph if the wholesale distributor notifies the department of the transaction no later than the next business day; or(d) Knowingly falsely creates a label for a medical gas or knowingly misrepresents a factual matter contained in a label for a medical gas.(2) A person found guilty of an offense under this section, under the authority of the court convicting and sentencing the person, shall be ordered to forfeit to the state any real or personal property:(a) Used or intended to be used to commit, to facilitate, or to promote the commission of such offense; and(b) Constituting, derived from, or traceable to the gross proceeds that the defendant obtained directly or indirectly as a result of the offense.(3) Property or assets subject to forfeiture under subsection (2) may be seized pursuant to a warrant obtained in the same manner as a search warrant or as otherwise authorized by law, and held until the case against a defendant is adjudicated. Moneys ordered forfeited, or proceeds from the sale of other assets ordered forfeited, shall be equitably divided between the department and other agencies involved in the investigation and prosecution that led to the conviction. Other property ordered forfeited after conviction of a defendant may, at the discretion of the investigating agencies, be placed into official use by the department or the agencies involved in the investigation and prosecution that led to the conviction.History.—s. 28, ch. 2014-89; s. 65, ch. 2015-2.
FL Stat § 499.93 (2021)
2021 Florida Statutes|Title XXXIII - Regulation of Trade, Commerce, Investments, and Solicitations|Chapter 499 - Florida Drug and Cosmetic Act|Part III - Medical Gas (Ss. 499.81-499.94)|499.93 - Inspections.

499.93 Inspections.—(1) The department may require a facility that engages in the manufacture, retail sale, or wholesale distribution of medical gas to undergo an inspection in accordance with a schedule to be determined by the department, including inspections for initial permitting, permit renewal, and a permitholder’s change of location. The department may recognize a third party to inspect wholesale distributors in this state or other states pursuant to a schedule to be determined by the department.(2) The department may recognize another state’s inspections of a manufacturer or wholesale distributor located in that state if such state’s laws are deemed to be substantially equivalent to the laws of this state by the department.(3) A manufacturing facility of medical gases is exempt from routine inspection by the department if:(a) The manufacturing facility is currently registered with the United States Food and Drug Administration under s. 510 of the federal act and can provide proof of registration, such as a copy of the Internet verification page; and(b) The manufacturing facility can provide proof of inspection by the Food and Drug Administration, or if the facility is located in another state, inspection by the Food and Drug Administration or other governmental entity charged with regulation of good manufacturing practices related to medical gases in that state within the past 3 years, which demonstrates substantial compliance with current good manufacturing practices applicable to medical gases.(4) A permitholder under this part shall exhibit or have readily available its state permits and its most recent inspection report administered by the department.History.—s. 29, ch. 2014-89.
FL Stat § 499.931 (2021)
2021 Florida Statutes|Title XXXIII - Regulation of Trade, Commerce, Investments, and Solicitations|Chapter 499 - Florida Drug and Cosmetic Act|Part III - Medical Gas (Ss. 499.81-499.94)|499.931 - Trade secret information.

499.931 Trade secret information.—Information required to be submitted under this part which is a trade secret as defined in s. 812.081 and designated as a trade secret by an applicant or permitholder must be maintained as required under s. 499.051. This section is subject to the Open Government Sunset Review Act in accordance with s. 119.15 and shall stand repealed on October 2, 2021, unless reviewed and saved from repeal through reenactment by the Legislature.History.—s. 30, ch. 2014-89; s. 12, ch. 2016-6.
FL Stat § 499.94 (2021)
2021 Florida Statutes|Title XXXIII - Regulation of Trade, Commerce, Investments, and Solicitations|Chapter 499 - Florida Drug and Cosmetic Act|Part III - Medical Gas (Ss. 499.81-499.94)|499.94 - Fees.

499.94 Fees.—A fee collected for a permit under this part shall be deposited into the Professional Regulation Trust Fund. Moneys collected under this part shall be used for administering this part. The department shall maintain a separate account in the trust fund for the Drugs, Devices, and Cosmetics program.History.—s. 31, ch. 2014-89.