Virginia Code 54.1-3415.1: Delivery of medical devices on behalf of a medical equipment supplier.
A. A permitted manufacturer, wholesale distributor, warehouser, nonresident warehouser, third-party logistics provider, or nonresident third-party logistics provider or registered nonresident manufacturer or nonresident wholesale distributor may deliver Schedule VI prescription devices directly to an ultimate user or consumer on behalf of a medical equipment supplier, provided that (i) such delivery occurs at the direction of a medical equipment supplier that has received a valid order from a prescriber authorizing the dispensing of such prescription device to the ultimate user or consumer and (ii) the manufacturer, nonresident manufacturer, wholesale distributor, nonresident wholesale distributor, warehouser, nonresident warehouser, third-party logistics provider, or nonresident third-party logistics provider has entered into an agreement with the medical equipment supplier for such delivery.
Terms Used In Virginia Code 54.1-3415.1
- Administer: means the direct application of a controlled substance, whether by injection, inhalation, ingestion, or any other means, to the body of a patient or research subject by (i) a practitioner or by his authorized agent and under his direction or (ii) the patient or research subject at the direction and in the presence of the practitioner. See Virginia Code 54.1-3401
- delivery: means the actual, constructive, or attempted transfer of any item regulated by this chapter, whether or not there exists an agency relationship, including delivery of a Schedule VI prescription device to an ultimate user or consumer on behalf of a medical equipment supplier by a manufacturer, nonresident manufacturer, wholesale distributor, nonresident wholesale distributor, warehouser, nonresident warehouser, third-party logistics provider, or nonresident third-party logistics provider at the direction of a medical equipment supplier in accordance with § Virginia Code 54.1-3401
- Device: means instruments, apparatus, and contrivances, including their components, parts, and accessories, intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals or to affect the structure or any function of the body of man or animals. See Virginia Code 54.1-3401
- Distributor: means a person who distributes. See Virginia Code 54.1-3401
- Manufacturer: means every person who manufactures, a manufacturer's co-licensed partner, or a repackager. See Virginia Code 54.1-3401
- Medical equipment supplier: means any person, as defined in § 1-230, engaged in the delivery to the ultimate consumer, pursuant to the lawful order of a practitioner, of hypodermic syringes and needles, medicinal oxygen, Schedule VI controlled devices, those Schedule VI controlled substances with no medicinal properties that are used for the operation and cleaning of medical equipment, solutions for peritoneal dialysis, and sterile water or saline for irrigation. See Virginia Code 54.1-3401
- Prescriber: means a practitioner who is authorized pursuant to §§ Virginia Code 54.1-3401
- Prescription: means an order for drugs or medical supplies, written or signed or transmitted by word of mouth, telephone, telegraph, or other means of communication to a pharmacist by a duly licensed physician, dentist, veterinarian, or other practitioner authorized by law to prescribe and administer such drugs or medical supplies. See Virginia Code 54.1-3401
- Third-party logistics provider: means a person that provides or coordinates warehousing of or other logistics services for a drug or device in interstate commerce on behalf of a manufacturer, wholesale distributor, or dispenser of the drug or device but does not take ownership of the product or have responsibility for directing the sale or disposition of the product. See Virginia Code 54.1-3401
- Warehouser: means any person, other than a wholesale distributor, manufacturer, or third-party logistics provider, engaged in the business of (i) selling or otherwise distributing prescription drugs or devices to any person who is not the ultimate user or consumer and (ii) delivering Schedule VI prescription devices to the ultimate user or consumer pursuant to § Virginia Code 54.1-3401
- Wholesale distributor: means any person other than a manufacturer, a manufacturer's co-licensed partner, a third-party logistics provider, or a repackager that engages in wholesale distribution. See Virginia Code 54.1-3401
B. A permitted manufacturer, wholesale distributor, warehouser, nonresident warehouser, third-party logistics provider, or nonresident third-party logistics provider, or registered nonresident manufacturer or nonresident wholesale distributor may deliver Schedule VI prescription devices directly to an ultimate user’s or consumer’s residence to be administered by persons authorized to administer such devices, provided that (i) such delivery is made on behalf of a medical director of a home health agency, nursing home, assisted living facility, or hospice who has requested the distribution of the Schedule VI prescription device and directs the delivery of such device to the ultimate user’s or consumer’s residence and (ii) the medical director on whose behalf such Schedule VI prescription device is being delivered has entered into an agreement with the manufacturer, nonresident manufacturer, wholesale distributor, nonresident wholesale distributor, warehouser, nonresident warehouser, third-party logistics provider, or nonresident third-party logistics provider for such delivery.