Amend SB 1645 (house committee printing) by adding the
following appropriately numbered SECTIONS to the bill and
renumbering subsequent SECTIONS of the bill accordingly:
SECTION ____. NORMAL DISTRIBUTION CHANNEL. Section
431.401(5), Health and Safety Code, is amended to read as follows:
(5) "Normal distribution channel" means a chain of
custody for a prescription drug, either directly or by drop
shipment, from the manufacturer of the prescription drug, the
manufacturer to the manufacturer's co-licensed product partner,
the manufacturer to the manufacturer's third-party logistics
provider, or the manufacturer to the manufacturer's exclusive
distributor, to:
(A) a pharmacy to:
(i) a patient; or
(ii) another designated person authorized
by law to dispense or administer the drug to a patient;
(B) an authorized distributor of record to:
(i) a pharmacy to a patient; or
(ii) another designated person authorized
by law to dispense or administer the drug to a patient;
(C) an authorized distributor of record to a
wholesale distributor licensed under this chapter to another
designated person authorized by law to dispense or administer the
drug to a patient;
(D) an authorized distributor of record to a
pharmacy warehouse to the pharmacy warehouse's intracompany
pharmacy;
(E) [(D)] a pharmacy warehouse to the pharmacy
warehouse's intracompany pharmacy or another designated person
authorized by law to dispense or administer the drug to a patient;
(F) [(E)] a person authorized by law to prescribe
a prescription drug that by law may be administered only under the
supervision of the prescriber; or
(G) [(F)] an authorized distributor of record to
one other authorized distributor of record to a licensed
practitioner for office use.
SECTION ____. EXEMPTION FROM CERTAIN PROVISIONS FOR CERTAIN
WHOLESALE DISTRIBUTORS. Section 431.4031, Health and Safety Code,
is amended to read as follows:
Sec. 431.4031. EXEMPTION FROM CERTAIN PROVISIONS FOR
CERTAIN WHOLESALE DISTRIBUTORS. (a) A wholesale distributor that
distributes prescription drugs that are medical gases or a
wholesale distributor that is a manufacturer or a third-party
logistics provider on behalf of a manufacturer is exempt from
Sections 431.404(a)(5) and (6), (b), and (c), 431.4045(2), 431.405,
431.407, and 431.408.
(b) A state agency or a political subdivision of this state
that distributes prescription drugs using federal or state funding
to nonprofit health care facilities or local mental health or
mental retardation authorities for distribution to a pharmacy,
practitioner, or patient is exempt from Sections 431.405(b),
431.407, 431.408, 431.412, and 431.413.
SECTION ____. RULES. As soon as practicable after the
effective date of this Act, the executive commissioner of the
Health and Human Services Commission shall adopt, modify, or repeal
rules as necessary to implement the changes in law made by this Act
to Chapter 431, Health and Safety Code.