C.S.H.B. 3486 78(R) BILL ANALYSIS C.S.H.B. 3486 By: Delisi Public Health Committee Report (Substituted) BACKGROUND AND PURPOSE Prescription drugs used in health care facilities are disposed of on a daily basis for many reasons. Often, these medications are in good condition, have not been utilized fully and could be used for other patients if initially packaged in tamper-resistant or blister packs. The Act authorizes the return of medications to the pharmacy that they were purchased from for reuse. RULEMAKING AUTHORITY It is the committee's opinion that rulemaking authority is expressly granted to the Texas State Board of Pharmacy in SECTION 1 (Section 562.1085, Occupations Code) of this bill. ANALYSIS The Act amends the Occupations Code by adding Section 562.1085 which authorizes the Texas Board of Pharmacy to adopt rules that would allow a resident or consulting pharmacist in a health care facility to return unused medications to the pharmacy from which it was purchased if the medication is sealed in unopened, individually packaged units and has not exceeded the recommended shelf life of the drug. The pharmacy may restock and redistribute the medication. The pharmacy will be required to reimburse or credit the health care faciltiy purchaser for any such returned medication. If before implementing Section 562.1085, Occupations Code, as added by this Act, a state agency determines that a waiver or authorization from a federal agency is necessary for implementation of that provision, the agency affected is required to request the waiver or authorization and is authorized to delay implementing that provision until the waiver or authorization is granted. The Board of Pharmacy has until December 1, 2003 to adopt the rules required by the Act. Pharmacies are not required to accept unused drugs until January 1, 2004. EFFECTIVE DATE Upon passage, or, if the Act does not receive the necessary vote, the Act takes effect September 1, 2003. COMPARISON OF ORIGINAL TO SUBSTITUTE The substitute differs from the original in that the effected language is moved from the Health and Safety Code to the Occupations Code where pharmacists are regulated The substitute gives the Board of Pharmacy until December 1, 2003 to adopt the rules required by the Act. The substitute states that pharmacies are not required to accept unused drugs until January 1, 2004. The substitute includes language instructing TDH to pursue federal waiver or authorization as necessary.