§ 53-10-208. Source of Products Substituted — Fda Approval Required
In making substitutions as allowed by this part, the pharmacist may use drugs and drug products manufactured within the territorial limits of any one (1) of the states of the United States, or of any other country, if the products have been approved by the federal food and drug administration (FDA), and have been given […]
§ 53-10-209. Construction
Nothing in this part shall be construed as authorizing any person or entity to interfere with a prescriber’s obligation to exercise independent medical judgment in rendering health care services to patients. Nothing in this part shall be construed to interfere with or otherwise limit, constrain or alter the ability of any health plan or payor, […]
§ 53-10-113. Off-Label Drug Use
As used in this section, and unless the context otherwise requires: “Misbranding” means either the federal definition under 21 U.S.C. § 352 or drugs or devices that are misbranded under § 53-10-106; and “Off-label” means the use of a United States food and drug administration (FDA) approved drug, biological product, or device other than the […]
§ 53-10-201. Short Title
This part shall be known and may be cited as the “Tennessee Affordable Drug Act of 2005.”
§ 53-10-202. Legislative Intent
The general assembly declares it to be the public policy that, in order to lower the cost of prescription drugs to its citizens, pharmacists may substitute less costly generic drugs or drug products for higher priced brand name or trade name drugs or drug products.
§ 53-10-203. Part Definitions
As used in this part, unless the context otherwise requires: “Biological product” has the same meaning as defined in 42 U.S.C. § 262(i); “Brand name” means the registered trademark name of a drug or drug product given by its manufacturer, labeler or distributor; “Finished dosage form” means that form of a drug that is, or […]
§ 53-10-103. Enforcement — Rules and Regulations — Fines
The board of pharmacy has the power to enforce this part and shall make rules and regulations for its enforcement. All fines collected under the enforcement of this part shall be paid to the board and deposited to the state treasury as other funds received by the board.
§ 53-10-104. Selling, Bartering, Giving Away or Obtaining Legend Drugs
It is unlawful for any person, firm or corporation to possess, sell, barter or give away any drug known as a legend drug, as defined in § 53-10-101, except upon the written prescription of a duly licensed physician; certified physician assistant; nurse authorized pursuant to § 63-6-204 or § 63-9-113, who is rendering service under […]
§ 53-10-105. Possession Without Prescription Unlawful
It is unlawful for any person to have in the person’s possession, any drug defined or enumerated in this part, without the drug having been prescribed by a duly licensed physician, certified physician assistant, dentist, optometrist authorized pursuant to § 63-8-102(12), or veterinarian, and having been dispensed by a pharmacy duly licensed and registered in […]
§ 53-10-106. Adulterated Drugs or Devices
Any drug or device that is misbranded, out of date, old, deteriorated, not kept under proper refrigeration as required, or that has been exposed to fire, heat, smoke, water, flood or windstorm damage is deemed to be adulterated, and the possession, sale or distribution of those drugs or devices is prohibited. Any drug or device […]