Alabama Administrative Code › Title 680 - ALABAMA STATE BOARD OF PHARMACY › Chapter 680-X-2 - PRACTICE OF PHARMACY › Section 680-X-2-.23 - Drug Manufacturers; Wholesale Distributors; Private Label Distributors, Repackagers, Third- Party Logistics, 503B Outsourcer; Reverse Distributor; Retail Medical Oxygen Supplier

Current through Register Vol. 42, No. 9, June 28, 2024
(1)
			 Definitions.
(a) Drug Manufacturer -Every
			 facility, except a pharmacy, that prepares, derives, produces, compounds, or
			 packages any drug, medicine, chemical or poison.
(b) Principals -Officers, directors and
			 primary stockholders of a business entity or corporation.
(c) Drugs -All medicinal substances,
			 preparations and devices recognized by the United States Pharmacopoeia and
			 National Formulary, or any revision thereof, and all substances and
			 preparations intended for external and internal uses in the cure, diagnosis,
			 mitigation, treatment or prevention of disease in man or animal and all
			 substances and preparations other than food intended to affect the structure or
			 any function of the body of man or animal.
(d) Medical Oxygen - Oxygen USP is liquid or
			 gaseous form intended for human consumption.
(e) Wholesale distributor -Every facility
			 engaged in the business of distributing drugs, to include medical oxygen, for
			 resale to pharmacies, hospitals, practitioners, government agencies or other
			 lawful outlets permitted to sell drugs. The sale, purchase, or trade of a drug
			 by a retail pharmacy to another retail pharmacy or practitioner, for relief of
			 temporary shortages is exempt from this definition. Also exempt from this
			 definition shall be (a) intracompany sales, (b) manufacturer and distributor
			 sales representatives who distribute drug samples, (c) charitable organizations
			 distributing to nonprofit affiliates of that organization, (d) certain
			 purchases by hospitals or other health care entities that are members of a
			 group purchasing organization, (e) the distributors of blood and blood
			 components, and (f) the sale, purchase, or trade of a drug, an offer to sell,
			 purchase, or trade a drug, or the dispensing of a drug pursuant to a
			 prescription.
(f) Private Label
			 Distributor - A firm that does not participate in the manufacturing or
			 processing of a drug but instead markets and distributes under its own trade
			 name, and labels a drug product made by someone else. A private label
			 distributor is responsible for the products it introduces into interstate
			 commerce and for compliance with federal Food, Drug and Cosmetic Act
			 requirements and Current Good Manufacturing Practices regulations.
(g) Repackager - facility that purchases or
			 acquires from a manufacturer or distributor, a drug, chemical, or poison for
			 the purpose of bottling, labeling, or otherwise repackaging for sale or
			 distribution. This definition shall not apply to a physician licensed to
			 practice medicine who as a part of his or her professional practice dispenses,
			 administers, sells, or otherwise distributes and drug to a patient.
(h) Third Party Logistics Provider -
			 (Abbreviated as 3PL, or TPL) An entity that provides or coordinates warehousing
			 or other logistics services of a product in interstate commerce on behalf of a
			 manufacturer or wholesale distributor of a product that neither takes ownership
			 of the product nor has responsibility to direct the sale or disposition of the
			 product.
(i) Outsourcing Facility -
			 A facility at one geographic location or address that is engaged in the
			 compounding of sterile drugs, which as elected to register with the Food and
			 Drug Administration as an outsourcing facility and complies with the
			 requirements of Section 503B(d)(4)(A) of the federal Food, Drug, and Cosmetic
			 Act.
(j) Reverse Distributor - A
			 facility that acts as an agent for pharmacies, wholesalers, third party
			 logistics providers, drug manufacturers and others by receiving, inventorying,
			 warehousing, and managing the disposition of outdated or nonsaleable drugs or
			 devices.
(k) Retail Medical Oxygen
			 Supplier - Any person, agency, business, or entity of any kind which sells or
			 provides medical oxygen to patients or consumers and which bill the patient or
			 consumer or their insurance, Medicare, Medicaid, or other third-party
			 payor.
(l) Charge Back -A process
			 whereby a wholesale drug distributor is reimbursed for preferential
			 pricing.
(m) Drug Sample -A unit of
			 a drug that is not intended to be sold and is intended to promote the sale of
			 the drug.
(n) Intracompany Sales
			 -Any transaction or transfer between any division, subsidiary, parent and/or
			 affiliated or related company under the common ownership and control of a
			 corporate entity.