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79R9874 MSE-D

By:  Wentworth                                                    S.B. No. 1476



A BILL TO BE ENTITLED

AN ACT

relating to regulation of dispensing brand name and generic 
prescriptions.  
	BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:                        
	SECTION 1.  Section 562.007, Occupations Code, is amended to 
read as follows:
	Sec. 562.007.  REFILLS.  A properly authorized prescription 
refill shall follow the original dispensing instruction unless 
otherwise indicated by the practitioner or the practitioner's 
agent.  A prescription may not be refilled with a generic equivalent 
if the original prescription form or dispensing directive required 
a specifically prescribed brand as medically necessary.
	SECTION 2.  Section 562.008, Occupations Code, is amended to 
read as follows:
	Sec. 562.008.  GENERIC EQUIVALENT AUTHORIZED.  (a)  If a 
practitioner certifies on the prescription form that a specific 
prescribed brand is medically necessary, the pharmacist shall 
dispense the drug as written by the practitioner.  The pharmacist 
may substitute a generically equivalent drug only if the 
practitioner certifies on the written prescription form that 
substitution is permitted.  A [The] certification must be made as 
required by the dispensing directive adopted under Section 562.015.  
This subchapter does not permit a pharmacist to substitute a 
generically equivalent drug unless the substitution is made as 
provided by this subchapter.
	(b)  Except as otherwise provided by this subchapter, a 
pharmacist who receives a prescription for a drug for which there is 
one or more generic equivalents may dispense any of the generic 
equivalents if otherwise permitted by the prescription or 
dispensing directive.
	SECTION 3.  Section 562.009(a), Occupations Code, is amended 
to read as follows:
	(a)  A pharmacist who selects a generically equivalent drug 
as authorized by this subchapter shall:
		(1)  personally, or through the pharmacist's agent or 
employee, and before delivery of a generically equivalent drug 
inform the patient or the patient's agent that a less expensive 
generically equivalent drug has been substituted for the brand 
prescribed and that the patient or the patient's agent is entitled 
to refuse that substitution; or
		(2)  display, in a prominent place that is in clear 
public view where prescription drugs are dispensed, a sign in block 
letters not less than one inch in height that reads, in both English 
and Spanish:
		"TEXAS LAW ALLOWS A LESS EXPENSIVE GENERICALLY 
EQUIVALENT DRUG TO BE SUBSTITUTED FOR CERTAIN BRAND 
NAME DRUGS ONLY IF [UNLESS] YOUR PHYSICIAN AUTHORIZES 
SUBSTITUTION [DIRECTS OTHERWISE]. YOU HAVE A RIGHT TO 
REFUSE SUCH SUBSTITUTION. CONSULT YOUR PHYSICIAN OR 
PHARMACIST CONCERNING THE AVAILABILITY OF A SAFE, LESS 
EXPENSIVE DRUG FOR YOUR USE."
	SECTION 4.  Section 562.015, Occupations Code, is amended to 
read as follows:
	Sec. 562.015.  DISPENSING DIRECTIVE; COMPLIANCE WITH 
FEDERAL LAW.  (a)  The board shall adopt rules to provide a 
dispensing directive to instruct pharmacists on the manner in which 
to dispense a drug according to the contents of a written
prescription or an electronically transmitted prescription.  The 
rules adopted under this section must:
		(1)  require the physician to sign on a line marked:                   
			(A)  [the use of the phrase] "brand necessary" [or 
"brand medically necessary"] on a prescription form to prohibit the 
substitution of a generically equivalent drug for a brand name 
drug; or
			(B)  "substitution permitted" on a prescription 
form to permit the substitution of a generically equivalent drug 
for a brand name drug;
		(2)  be in a format that protects confidentiality as 
required by the Health Insurance Portability and Accountability Act 
of 1996 (29 U.S.C. Section 1181 et seq.) and its subsequent 
amendments;
		(3)  comply with federal and state law, including 
rules, with regard to formatting and security requirements;
		(4)  be developed to coordinate with 42 C.F.R. Section 
447.331(c); and      
		(5)  require that an electronically transmitted 
prescription include "brand necessary" or "brand medically 
necessary" to prohibit the substitution of a generically equivalent 
drug for a brand name drug [include an exemption for electronic 
prescriptions as provided by Subsection (b)].
	(b)  [The board shall provide an exemption from the directive 
adopted under this section for prescriptions transmitted 
electronically.]  The board may regulate the use of electronic 
prescriptions in the manner provided by federal law, including 
rules.
	SECTION 5.  Not later than January 1, 2006, the Texas State 
Board of Pharmacy shall adopt rules as required by Section 562.015, 
Occupations Code, as amended by this Act.
	SECTION 6.  This Act takes effect September 1, 2005.