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.