24 Del. Admin. Code § 2500-18.0
Current through Register Vol. 28, No. 5, November 1, 2024
Section 2500-18.0 - Storage and Dispensing of Medical Gases18.1 The following rules are included to address those areas specific to the medical gases specialty practice. "Medical gas" means those gases and liquid oxygen intended for human consumption as per the standards of the U.S.P.
"Medical gas dispenser" A person or entity who sells medical gases directly to a patient in Delaware.
"Medical gas distributor" A person or entity who is licensed to distribute medical gases to another facility that is authorized to possess medical gases.
"Order" means an order issued by a licensed practitioner legally authorized to order medicinal gases.
18.2 Licensure and Registration 18.2.1 Any person that dispenses medical gas directly to patients by sale shall register with the Board of Pharmacy pursuant to 24 Del.C. § 2523. Applications for registration under this Regulation shall be on a form supplied by the Board and accompanied by a fee determined by the Board. The registration shall be renewed bi-biennially as determined by the Board. 18.2.1.1 A medical gas dispenser may refill cylinders for a patient provided that the licensee is registered by the FDA.18.2.2 Distributors of medical gas who distribute to non-patient entities shall obtain a distributor license from the Board of Pharmacy pursuant to 24 Del.C. § 2540.18.3 Order Requirements 18.3.1 Verbal orders: 18.3.1.1 Verbal orders shall be reduced to writing.18.3.1.2 Verbal orders are only valid for oxygen and no other medical gases.18.3.1.3 Verbal orders shall be reviewed by a licensed healthcare professional authorized to administer oxygen to a patient. This review shall be performed within 72 hours.18.3.1.4 The order is valid for the length of time authorized by the prescriber. If the duration is not specified the order is valid for one year.18.4 Policy and Procedure Requirements 18.4.1 Written policy and procedures must be available for review and shall include but not be limited to the following areas: 18.4.1.1 Storage and handling18.4.1.6 Patient education18.5 Training Requirements 18.5.1 Personnel shall be trained in areas to comply with standards dictated by the United States Pharmacopoeia, the Food Drug Administration, the Department of Transportation, the Occupational Safety and Health Administration, the Board of Pharmacy, any other applicable requirement under State and Federal law and any implementing rules or regulations regarding storage, packaging, labeling, shipping, dispensing, transfilling, distributing and repackaging of medical gas.18.5.2 Documentation of training required by this Regulation shall be readily available for inspection. The documentation shall be kept for three years from the date of last employment.18.6 Storage and Handling Requirements18.6.1 Storage and handling of medical gas shall follow the manufacturer's labeling requirements.18.6.2 Labeling shall include the manufacturer's label and a lot number on the cylinder in accordance with the Federal Food Drug and Cosmetic Act under Title 21 of the Code of Federal Regulation.18.7 Record Keeping Requirements18.7.1 The original order shall be kept and be readily retrievable for a minimum of three years after the date of the last dispensing.18.7.2 Records shall include but not be limited to: 18.7.2.1 Name, address and telephone number of the patient18.7.2.2 Name, address and telephone number of licensed practitioner18.7.2.3 Item and quantity dispensed18.7.2.4 Date of dispensing18.8 Inspections 18.8.1 Inspections are conducted unannounced, during normal business hours, in accordance with 24 Del.C. § 2534.24 Del. Admin. Code § 2500-18.0
13 DE Reg. 506 (10/01/09)