1-1 By: Armbrister S.B. No. 561
1-2 (In the Senate - Filed March 2, 1993; March 3, 1993, read
1-3 first time and referred to Committee on Health and Human Services;
1-4 April 6, 1993, reported adversely, with favorable Committee
1-5 Substitute by the following vote: Yeas 9, Nays 0; April 6, 1993,
1-6 sent to printer.)
1-7 COMMITTEE VOTE
1-8 Yea Nay PNV Absent
1-9 Zaffirini x
1-10 Ellis x
1-11 Madla x
1-12 Moncrief x
1-13 Nelson x
1-14 Patterson x
1-15 Shelley x
1-16 Truan x
1-17 Wentworth x
1-18 COMMITTEE SUBSTITUTE FOR S.B. No. 561 By: Truan
1-19 A BILL TO BE ENTITLED
1-20 AN ACT
1-21 relating to licensing exemptions for wholesale distribution of
1-22 prescription drugs.
1-23 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
1-24 SECTION 1. Subsection (a), Section 431.2021, Health and
1-25 Safety Code, is amended to read as follows:
1-26 (a) A person who engages in wholesale distribution of
1-27 prescription drugs in this state for use in humans is exempt from
1-28 this subchapter if the person is exempt under:
1-29 (1) the Prescription Drug Marketing Act of 1987, as
1-30 amended (21 U.S.C. Section 353(c)(3)(B));
1-31 (2) the regulations adopted by the secretary to
1-32 administer and enforce that Act; or
1-33 (3) the interpretations of that Act set out in the
1-34 compliance policy manual of the United States Food and Drug
1-35 Administration <Persons who engage only in the following types of
1-36 wholesale drug distribution are exempt from the licensing
1-37 requirements of this subchapter:>
1-38 <(1) intracompany sales;>
1-39 <(2) the purchase or acquisition by a hospital or
1-40 other health care entity that is a member of a group purchasing
1-41 organization of a drug for its own use from the group purchasing
1-42 organization or from other hospitals or health care entities that
1-43 are members of such organizations;>
1-44 <(3) the sale, purchase, or trade of a drug or an
1-45 offer to sell, purchase, or trade a drug by a charitable
1-46 organization described in Section 501(c)(3) of the Internal Revenue
1-47 Code of 1986 to a nonprofit affiliate of the organization to the
1-48 extent otherwise permitted by law;>
1-49 <(4) the sale, purchase, or trade of a drug or an
1-50 offer to sell, purchase, or trade a drug among hospitals or other
1-51 health care entities that are under common control; for the purpose
1-52 of this section, "common control" means the power to direct or
1-53 cause the direction of the management and policies of a person or
1-54 an organization, whether by ownership of stock, voting rights,
1-55 contract, or otherwise;>
1-56 <(5) the sale, purchase, or trade of a drug or an
1-57 offer to sell, purchase, or trade a drug for emergency medical
1-58 reasons; for purposes of this section, "emergency medical reasons"
1-59 includes transfers of prescription drugs by a retail pharmacy to
1-60 another retail pharmacy to alleviate a temporary shortage;>
1-61 <(6) the sale, purchase, or trade of a drug, an offer
1-62 to sell, purchase, or trade a drug, or the dispensing of a drug
1-63 pursuant to a prescription;>
1-64 <(7) the distribution of drug samples by
1-65 manufacturers' representatives or distributors' representatives; or>
1-66 <(8) the sale, purchase, or trade of blood and blood
1-67 components intended for transfusion>.
1-68 SECTION 2. The importance of this legislation and the
2-1 crowded condition of the calendars in both houses create an
2-2 emergency and an imperative public necessity that the
2-3 constitutional rule requiring bills to be read on three several
2-4 days in each house be suspended, and this rule is hereby suspended,
2-5 and that this Act take effect and be in force from and after its
2-6 passage, and it is so enacted.
2-7 * * * * *
2-8 Austin,
2-9 Texas
2-10 April 6, 1993
2-11 Hon. Bob Bullock
2-12 President of the Senate
2-13 Sir:
2-14 We, your Committee on Health and Human Services to which was
2-15 referred S.B. No. 561, have had the same under consideration, and I
2-16 am instructed to report it back to the Senate with the
2-17 recommendation that it do not pass, but that the Committee
2-18 Substitute adopted in lieu thereof do pass and be printed.
2-19 Zaffirini,
2-20 Chair
2-21 * * * * *
2-22 WITNESSES
2-23 FOR AGAINST ON
2-24 ___________________________________________________________________
2-25 Name: Dennis E. Baker x
2-26 Representing: Tx Dept. of Health
2-27 City: Austin
2-28 -------------------------------------------------------------------
2-29 Name: Chuck Courtney x
2-30 Representing: Tx Retailers Assn
2-31 City: Austin
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2-33 Name: Richard Beck x
2-34 Representing: Tx Pharmaceutical Assn
2-35 City: Austin
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