By: Armbrister S.B. No. 561
73R907 MLR-F
A BILL TO BE ENTITLED
1-1 AN ACT
1-2 relating to licensing exemptions for wholesale distribution of
1-3 prescription drugs.
1-4 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
1-5 SECTION 1. Section 431.2021(a), Health and Safety Code, is
1-6 amended to read as follows:
1-7 (a) A person who engages in wholesale distribution of drugs
1-8 in this state for use in humans is exempt from this subchapter if
1-9 the person is exempt under:
1-10 (1) the Prescription Drug Marketing Act of 1987, as
1-11 amended (21 U.S.C. Section 353(c)(3)(B));
1-12 (2) the regulations adopted by the secretary to
1-13 administer and enforce that Act; or
1-14 (3) the interpretations of that Act set out in the
1-15 compliance policy manual of the United States Food and Drug
1-16 Administration <Persons who engage only in the following types of
1-17 wholesale drug distribution are exempt from the licensing
1-18 requirements of this subchapter:>
1-19 <(1) intracompany sales;>
1-20 <(2) the purchase or acquisition by a hospital or
1-21 other health care entity that is a member of a group purchasing
1-22 organization of a drug for its own use from the group purchasing
1-23 organization or from other hospitals or health care entities that
1-24 are members of such organizations;>
2-1 <(3) the sale, purchase, or trade of a drug or an
2-2 offer to sell, purchase, or trade a drug by a charitable
2-3 organization described in Section 501(c)(3) of the Internal Revenue
2-4 Code of 1986 to a nonprofit affiliate of the organization to the
2-5 extent otherwise permitted by law;>
2-6 <(4) the sale, purchase, or trade of a drug or an
2-7 offer to sell, purchase, or trade a drug among hospitals or other
2-8 health care entities that are under common control; for the purpose
2-9 of this section, "common control" means the power to direct or
2-10 cause the direction of the management and policies of a person or
2-11 an organization, whether by ownership of stock, voting rights,
2-12 contract, or otherwise;>
2-13 <(5) the sale, purchase, or trade of a drug or an
2-14 offer to sell, purchase, or trade a drug for emergency medical
2-15 reasons; for purposes of this section, "emergency medical reasons"
2-16 includes transfers of prescription drugs by a retail pharmacy to
2-17 another retail pharmacy to alleviate a temporary shortage;>
2-18 <(6) the sale, purchase, or trade of a drug, an offer
2-19 to sell, purchase, or trade a drug, or the dispensing of a drug
2-20 pursuant to a prescription;>
2-21 <(7) the distribution of drug samples by
2-22 manufacturers' representatives or distributors' representatives; or>
2-23 <(8) the sale, purchase, or trade of blood and blood
2-24 components intended for transfusion>.
2-25 SECTION 2. The importance of this legislation and the
2-26 crowded condition of the calendars in both houses create an
2-27 emergency and an imperative public necessity that the
3-1 constitutional rule requiring bills to be read on three several
3-2 days in each house be suspended, and this rule is hereby suspended,
3-3 and that this Act take effect and be in force from and after its
3-4 passage, and it is so enacted.