(1) A prescription device in the possession of a salvage establishment or salvage broker licensed under these sections of this subchapter is exempt from Health and Safety Code, §431.112(f)(1), relating to labeling bearing adequate directions for use, providing it meets the requirements of 21 CFR, §801.109 (prescription devices) and 21 CFR, §801.110 (retail exemption for prescription devices). (2) Each salvage establishment or salvage broker who sells or distributes a prescription device shall establish and maintain a record for every prescription device, showing the identity and quantity received, date of receipt, and the disposition of each device. (3) Each salvage establishment or salvage broker who delivers a prescription device to the ultimate user shall maintain a record of any prescription or other order lawfully issued by a practitioner in connection with the device. (q) Sale of contact lenses at flea markets. Persons at flea markets may not sell contact lens devices unless: (1) the person selling the contact lenses has complied with the requirements of Business and Commerce Code, §35.55; and (2) the person selling the contact lenses has complied with the requirements of the Texas Contact Lens Prescription Act, Texas Civil Statutes, Article 4552-A. |