Texas § OC.562.1085 - UNUSED DRUGS RETURNED BY CERTAIN PHARMACISTS

§ OC.562.1085. UNUSED DRUGS RETURNED BY CERTAIN PHARMACISTS

UNUSED DRUGS RETURNED BY CERTAIN PHARMACISTS. (a) A pharmacist who practices in or serves as a consultant for a health care facility or a licensed health care professional responsible for administration of drugs in a penal institution, as defined by Section 1.07 , Penal Code, in this state may return to a pharmacy certain unused drugs, other than a controlled substance as defined by Chapter 481 , Health and Safety Code, purchased from the pharmacy as provided by board rule. The unused drugs must: (1) be approved by the federal Food and Drug Administration and be: (A) sealed in unopened tamper-evident packaging and either individually packaged or packaged in unit-dose packaging; (B) oral or parenteral medication in sealed single-dose containers approved by the federal Food and Drug Administration; (C) topical or inhalant drugs in sealed units-of-use containers approved by the federal Food and Drug Administration; or (D) parenteral medications in sealed multiple-dose containers approved by the federal Food and Drug Administration from which doses have not been withdrawn; and (2) not be the subject of a mandatory recall by a state or federal agency or a voluntary recall by a drug seller or manufacturer. (b) A pharmacist for the pharmacy shall examine a drug returned under this section to ensure the integrity of the drug product. A health care facility or penal institution may not return a drug that: (1) has been compounded; (2) appears on inspection to be adulterated; (3) requires refrigeration; or (4) has less than 120 days until the expiration date or end of the shelf life. (c) The pharmacy may restock and redistribute unused drugs returned under this section. (d) The pharmacy shall reimburse or credit the state Medicaid program for an unused drug returned under this section. (e) The board shall adopt the rules, policies, and procedures necessary to administer this section, including rules that require a health care facility to inform the Health and Human Services Commission of medicines returned to a pharmacy under this section. (f) The tamper-evident packaging required under Subsection (a)(1) for the return of unused drugs is not required to be the manufacturer's original packaging unless that packaging is required by federal law. Added by Acts 2003, 78th Leg., ch. 198, Sec. 2.126, eff. Sept. 1, 2003; Acts 2003, 78th Leg., ch. 321, Sec. 1, eff. June 18, 2003. Amended by: Acts 2005, 79th Leg., Ch. 349 (S.B. 1188 ), Sec. 14, eff. September 1, 2005. Acts 2007, 80th Leg., R.S., Ch. 820 (S.B. 1896 ), Sec. 1, eff. June 15, 2007.