535:20-9-4 - Medical gas distributors

535:20-9-4. Medical gas distributors

(a) Licensing requirement. Before conducting interstate and or intrastate transactions in Oklahoma, a medical gas distributor shall register annually with the Board.

(1) A medical gas distributor license is only valid for the name, ownership and location listed on the license. Changes of name, ownership or location shall require a new medical gas distributor license.

(2) Changes in any information required for licensure must be reported to the Board within ten (10) days (e.g. manager, contact person, phone, etc.)

(3) Each location shall possess a medical gas distributor license. Medical gas distributor license entitles the holder to store and distribute medical gas (prescription drugs) at the licensed location.

(4) A medical gas distributor shall not operate from a place of residence.

(5) A medical gas distributor shall not operate from a storage unit.

(b) License issuance. Licenses shall be issued only to those medical gas distributors who satisfy the provisions of: 59, O.S. Section 353.18 (B)(1)(2) et seq., and the requirements under the Act, this Title and the rules in 535:25 for applicants.

(c) Compliance with federal requirements. Medical gas distributor applicants and registrants shall meet the federal requirements to handle medical gas, the Prescription Drug Marketing Act (PDMA, 21 U.S.C., Sec. 331 et seq.); and/or any other applicable federal, state, or local laws and regulations. Medical gas distributor applicants and registrants shall be registered with the federal Food and Drug Administration (FDA), if required.

(d) Minimum required information for licensure. The minimum required information for medical gas distributors licensure shall be as follows, Medical gas distributor applicants must submit a satisfactorily completed application together with the required fee annually. This application shall include, at least, the following:

(1) The name, full business address, and telephone number;

(2) All trade or business names used by the manufacturer applicant;

(3) Address, telephone numbers, and the names of contact persons for the manufacturing facility;

(4) The type of ownership or operation (e.g., partnership, corporation, or sole proprietorship);

(5) The name(s) of the owner and/or operator of the manufacturer applicant; and

(6) Any other information the Board deems necessary to protect the public health.

(e) Minimum qualifications. Medical gas distributors must conform to the Compressed Medical Gases Guidelines published by the Department of Health and Human Services, Food and Drug Administration.

(1) Medical gas distributors must conform to all applicable federal, state or local laws and regulations.

(2) The minimum qualifications shall be the same as those set forth in 535:25 and this Chapter. The Board shall consider, at a minimum, the following factors in reviewing the qualifications of persons who engage in medical gas distribution:

(A) Any convictions of the applicant under any federal, state, or local laws relating to drugs, drug samples, manufacture, packager, wholesale or retail drug distribution, or distribution of controlled substances;

(B) Any felony convictions of the applicant under federal, state, or local laws;

(C) The applicant's past experience in the handling, manufacture, packaging or distribution of drugs, including controlled substances;

(D) The furnishing by the applicant of false or fraudulent material in any application made in connection with drug or device handling, manufacturing, packing, or distribution;

(E) Suspension, sanction, or revocation by federal, state, or local government of any license currently or previously held by the applicant for the handling, manufacture, packaging, or distribution of any drugs, including controlled substances; or by any of its owners for violation of state or federal laws regarding drugs or devices;

(F) Compliance with licensing requirements under previously granted licenses, if any;

(G) Compliance with requirements to maintain and/or make available to the Board or to federal, state, or local law enforcement officials those records required under this section; and,

(H) Any other factors or qualifications the Board considers relevant to and consistent with the public health and safety.

(3) The Board shall have the right to deny a license to an applicant if it determines that the granting of such a license would not be consistent with the public health and safety.

(f) Personnel. Personnel employed by medical gas distributors shall have sufficient education, training, and/or experience to perform assigned functions and comply with federal, state and local licensing requirements.

(g) Minimum requirements. Medical gas distributors must meet minimum requirements for storage and handling, and for the establishment and maintenance of distribution records for medical gases.

(1) The following shall describe the minimum requirements for the storage and handling of medical gas prescription drugs, and for the establishment and maintenance of drug records by medical gas distributors and their officers, agents, representatives, and employees.

(A) All medical gas distributors of drugs shall conform to U. S. Food and Drug Administration (FDA) requirements for medical gas prescription drugs.

(B) All medical gas distributors shall conform to the Act and the rules of this Title.

(C) Each facility at which drugs are stored, warehoused, handled, held, offered, marketed, or displayed shall:

(i) Be licensed by the Board;

(ii) Be of suitable size and construction to facilitate cleaning, maintenance, and proper operations;

(iii) Have storage areas designed to provide adequate lighting, ventilation, temperature, sanitation, humidity, space, equipment, and security conditions;

(iv) Have a quarantine area for storage of drugs that are outdated, damaged, deteriorated, mis-branded, or adulterated, or that are in immediate or sealed, secondary containers that have been opened;

(v) Be maintained in a clean and orderly condition; and,

(vi) Be free from infestation by insects, rodents, birds, or vermin of any kind.

(2) Medical gases housed by a medical gas distributor shall conform to the Compressed Medical Gases Guidelines published by the Department of Health and Human Services, Food and Drug Administration.

(h) Prescription requirements. Medical gas distributors shall distribute only to an entity licensed to receive medical gas or upon a prescriber's drug order. A pharmacy, dentist, or licensed prescriber's license verifies their authority to receive Rx Only medical gases.

(1) An original or copy of a prescription drug order must be kept at the licensed location distributing the medical gas.

(2) A prescription drug order is only valid for one (1) year. Prescription drug orders shall be maintained for five years and be readily retrievable and available at inspection.

(3) Distributors that sell to licensed medical gas suppliers must keep an updated copy of each supplier's license on file.

(i) Minimum requirements for storage, handling and records for medical gas Rx Only drugs. The following shall describe the minimum requirements for the storage and handling of medical gas prescription drugs, and for the establishment and maintenance of drug records by medical gas distributors and their officers, agents, representatives, and employees.

(1) Security. Each facility used for medical gases shall be secure from unauthorized entry.

(A) Access from outside the premises shall be kept to a minimum and be well controlled.

(B) The outside perimeter of the premises shall be well-lighted.

(C) Entry into areas where drugs are held shall be limited to authorized personnel.

(D) All medical gas distributors shall establish and maintain controls and systems that protect against, detect, and document any instances of theft, diversion, or counterfeiting. When appropriate, the security system shall provide protection against theft or diversion that is facilitated or hidden by tampering with computers or electronic records.

(E) All medical gas distributors shall establish and maintain a suspicious order monitoring program for controlled substances and dangerous drugs with a high likelihood of abuse:

(i) The medical gas distributor must not ship the customer's order if the order is confirmed as suspicious;

(ii) Each medical gas distributor shall notify the Board, within ten (10) days, if an order is confirmed as suspicious; and, (iii) Medical gas distributors shall establish guidelines and procedures for identifying dangerous drugs with a high likelihood of abuse and suspicious orders.

(2) Storage. All drugs shall be stored at appropriate temperatures and under appropriate conditions in accordance with requirements, if any, in the labeling of such drugs, or with the requirements in the current edition of an official compendium, such as the United States Pharmacopeia/National Formulary (USP/NF).

(A) If no storage requirements are established for a drug, the drug may be held at "controlled" room temperature, as defined in an official compendium, to help ensure that its identity, strength, quality, and purity are not adversely affected.

(B) Appropriate manual, electromechanical, or electronic temperature and humidity recording equipment, devices, and/or logs shall be utilized to document proper storage of drugs, if required.

(C) The recordkeeping requirement in this Chapter for medical gas distributors shall be followed for all stored drugs.

(3) Examination of materials. Upon receipt, each outside shipping container shall be visually examined for identity and to prevent the acceptance of contaminated drugs or chemicals that are unfit. This examination shall be adequate to reveal container damage that would suggest possible contamination or other damage to the contents.

(A) Each outgoing shipment shall be carefully inspected for identity of the drug products and to ensure that there is no delivery of drugs that have been damaged in storage or held under improper conditions.

(B) The recordkeeping requirement in this Chapter shall be followed for all incoming and outgoing drugs.

(4) Returned, damaged, and outdated drugs. Drugs that are outdated, damaged, deteriorated, misbranded, or adulterated shall be quarantined and physically separated from other drugs until they are destroyed.

(A) If the conditions under which a drug has been returned cast doubt on the drug's safety, identity, strength, quality or purity, then the drug shall be destroyed, unless examination, testing, or other investigation proves that the drug meets appropriate standards of safety, identity, quality, strength, and purity. In determining whether the conditions under which a drug has been returned cast doubt on the drug's safety, identity, strength, quality or purity, the medical gas distributors shall consider, among other things:

(i) The conditions under which the drug has been held, stored or shipped before or during its return; and,

(ii) The condition of the drug and its container, carton, or labeling, as a result of storage or shipping.

(B) The recordkeeping requirements for medical gas distributors in this Chapter shall be followed for all outdated, damaged, deteriorated, misbranded or adulterated drugs.

(5) Recordkeeping. Medical gas distributors shall establish and maintain inventories and records of all transactions regarding the receipt and distribution or other disposition of drugs.

(A) Inventories and records shall be made available for inspection and photocopying by authorized federal, state, or local law enforcement agency officials for a period of two (2) years following disposition of the drugs.

(B) Records described in this section that are 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 two (2) working days of a request by an authorized official of a federal, state, or local law enforcement agency.

(C) Each medical gas distributor should maintain an ongoing list of persons with whom they do business.

(6) Written policies and procedures. Medical gas distributors shall establish, maintain, and adhere to written policies and procedures, which shall be followed for the receipt, security, storage, inventory, and distribution of drugs, including policies and procedures for identifying, recording, and reporting losses or thefts, and for correcting all errors and inaccuracies in inventories.

(A) Medical gas distributors shall include in their written policies and procedures the following; A procedure to be followed for handling recalls and withdrawals of drugs. Such procedure shall be adequate to deal with recalls and withdrawals due to any:

(i) Action initiated at the request of the Food and Drug Administration (FDA) or other federal, state, or local law enforcement or other government agency, including the Board;

(ii) Voluntary action by the medical gas distributor to remove defective or potentially defective drugs from the market; or

(iii) Action undertaken to promote public health and safety by replacing of existing merchandise with an improved product or new package design.

(B) A procedure to ensure that medical gas distributors prepare for, protect against, and handle a crisis that affects security or operation of any facility in the event of strike, fire, flood, or other natural disaster, or other situations of local, state or national emergency.

(C) A procedure to ensure that any outdated drugs shall be segregated from other drugs and destroyed.

(i) This procedure shall provide for written documentation of the disposition of outdated drugs.

(ii) This documentation shall be maintained for two (2) years after disposition of the outdated drugs.

(7) Responsible persons. Medical gas distributors shall establish and maintain lists of officers, directors, managers and other persons in charge of drug distribution, storage, and handling, including a description of their duties and a summary of their qualifications.

(8) Compliance with federal, state and local laws. Medical gas distributors shall operate in compliance with applicable federal, state, and local laws and regulations.

(A) Medical gas distributors shall permit the Board and authorized federal, state, and local law enforcement officials to enter and inspect their premises and delivery vehicles, and to audit their records and written operating procedures and to confiscate records, to the extent authorized by law and rule.

(B) Medical gas distributors that deal in controlled substances shall register with the appropriate state controlled substance authority and with the Drug Enforcement Administration (DEA), and shall comply with all applicable state, local and DEA regulation.

(9) Salvaging and reprocessing. Medical gas distributors shall be subject to the provisions of any applicable federal, state or local laws or regulations that relate to drug product salvaging or reprocessing including U.S. 21 CFR Parts 207, 210, and 211.

(Amended by Oklahoma Register, Volume 32, Issue 23, August 17, 2015, eff. 8/27/2015 Amended by Oklahoma Register, Volume 33, Issue 24, September 1, 2016, eff. 9/11/2016 Amended by Oklahoma Register, Volume 35, Issue 24, September 4, 2018, eff. 9/14/2018)

Added at 10 Ok Reg 3175, eff 6-25-93; Amended at 18 Ok Reg 2749, eff 7-1-01; Amended at 21 Ok Reg 2458, eff 7-1-04; Amended at 26 Ok Reg 2296, eff 7-1-09; Amended at 27 Ok Reg 2261, eff 7-11-10

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