1-1 AN ACT
1-2 relating to allowing the donation of certain unused prescription
1-3 drugs to charitable medical clinics.
1-4 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
1-5 SECTION 1. Chapter 431, Health and Safety Code, is amended
1-6 by adding Subchapter M to read as follows:
1-7 SUBCHAPTER M. DRUG DONATION PROGRAM
1-8 Sec. 431.321. DEFINITIONS. (a) "Charitable medical clinic"
1-9 means a clinic that provides medical care without charge or for a
1-10 substantially reduced charge, complies with the insurance
1-11 requirements of Chapter 84, Civil Practice and Remedies Code, and
1-12 is exempt from federal income tax under Section 501(a) of the
1-13 Internal Revenue Code of 1986 by being listed as an exempt
1-14 organization in Section 501(c)(3) or 501(c)(4) of the code and is
1-15 operated exclusively for the promotion of social welfare by being
1-16 primarily engaged in promoting the common good and general welfare
1-17 of the people in a community.
1-18 (b) "Seller" means a person, other than a charitable drug
1-19 donor, as defined in Chapter 82, Civil Practice and Remedies Code.
1-20 (c) "Manufacturer" means a person, other than a charitable
1-21 drug donor, as defined in Chapter 82, Civil Practice and Remedies
1-22 Code.
1-23 (d) "Charitable drug donor" means a licensed convalescent or
1-24 nursing home or related institution, licensed hospice, hospital,
2-1 physician, pharmacy, or a pharmaceutical seller or manufacturer
2-2 that donates drugs pursuant to a qualified patient assistance
2-3 program, that donates drugs to a charitable medical clinic.
2-4 (e) In this subchapter, "patient assistance program" means a
2-5 qualified program offered by a pharmaceutical manufacturer under
2-6 which the manufacturer provides drugs to financially disadvantaged
2-7 persons at no charge or at a substantially reduced cost. The term
2-8 does not include the provision of a drug as part of a clinical
2-9 trial.
2-10 Sec. 431.322. DONATION OF UNUSED DRUGS TO CHARITABLE MEDICAL
2-11 CLINIC. (a) A charitable drug donor may donate certain unused
2-12 prescription drugs to a charitable medical clinic, and a charitable
2-13 clinic may accept, dispense, or administer the donated drugs in
2-14 accordance with this subchapter.
2-15 (b) A seller or manufacturer of a drug may not donate drugs
2-16 to a charitable medical clinic except pursuant to a qualified
2-17 patient assistance program. A seller or manufacturer of a drug
2-18 that donates drugs through a qualified patient assistance program
2-19 shall be considered a charitable drug donor.
2-20 (c) The charitable drug donor shall use appropriate
2-21 safeguards established by the board to ensure that the drugs are
2-22 not compromised or illegally diverted while being stored or
2-23 transported to the charitable medical clinic.
2-24 (d) The charitable medical clinic may not accept the donated
2-25 drugs unless:
2-26 (1) the charitable drug donor certifies that the drugs
2-27 have been properly stored while in the possession of the donor or
3-1 of the person for whom the drugs were originally dispensed;
3-2 (2) the charitable drug donor provides the clinic with
3-3 a verifiable address and telephone number; and
3-4 (3) the person transferring possession of the drugs
3-5 presents the charitable medical clinic with photographic
3-6 identification.
3-7 Sec. 431.323. CIRCUMSTANCES UNDER WHICH DONATED DRUGS MAY BE
3-8 ACCEPTED AND DISPENSED. (a) A charitable medical clinic may
3-9 accept and dispense or administer donated drugs only in accordance
3-10 with this subchapter.
3-11 (b) The donated drugs must be drugs that require a
3-12 prescription. A donated drug may not be a controlled substance
3-13 under Chapter 481.
3-14 (c) The donated drugs must be approved by the federal Food
3-15 and Drug Administration and:
3-16 (1) be sealed in the manufacturer's unopened original
3-17 tamper-evident packaging and either:
3-18 (A) individually packaged; or
3-19 (B) packaged in unit-dose packaging;
3-20 (2) be oral or parenteral medication in sealed
3-21 single-dose containers approved by the federal Food and Drug
3-22 Administration;
3-23 (3) be topical or inhalant drugs in sealed
3-24 units-of-use containers approved by the federal Food and Drug
3-25 Administration; or
3-26 (4) be parenteral medication in sealed multiple-dose
3-27 containers approved by the federal Food and Drug Administration
4-1 from which no doses have been withdrawn; and
4-2 (5) must not be the subject of a mandatory recall by a
4-3 state or federal agency or a voluntary recall by a drug seller or
4-4 manufacturer.
4-5 (d) The charitable medical clinic may dispense or administer
4-6 the donated drugs only:
4-7 (1) before the expiration date or within the
4-8 recommended shelf life of the donated drugs, as applicable; and
4-9 (2) after a licensed pharmacist has determined that
4-10 the drugs are of an acceptable integrity.
4-11 (e) The donated drugs may be accepted and dispensed or
4-12 administered by the charitable medical clinic only in accordance
4-13 with rules adopted by the department.
4-14 Sec. 431.324. RULES. The department shall adopt rules to
4-15 implement this subchapter that are designed to protect the public
4-16 health and safety.
4-17 Sec. 431.325. LIMITATION ON LIABILITY. (a) Charitable drug
4-18 donors, charitable medical clinics, and their employees are not
4-19 liable for harm caused by the accepting, dispensing, or
4-20 administering of drugs donated in strict compliance with this
4-21 subchapter unless the harm is caused by:
4-22 (i) willful or wanton acts of negligence;
4-23 (ii) conscious indifference or reckless disregard for
4-24 the safety of others; or
4-25 (iii) intentional conduct.
4-26 (b) This section does not limit, or in any way affect or
4-27 diminish, the liability of a drug seller or manufacturer pursuant
5-1 to Chapter 82, Civil Practice and Remedies Code.
5-2 (c) This section shall not apply where harm results from the
5-3 failure to fully and completely comply with the requirements of
5-4 this subchapter.
5-5 (d) This section shall not apply to a charitable medical
5-6 clinic that fails to comply with the insurance provisions of
5-7 Chapter 84, Civil Practice and Remedies Code.
5-8 SECTION 2. Section 431.021, Health and Safety Code, is
5-9 amended to read as follows:
5-10 Sec. 431.021. PROHIBITED ACTS. The following acts and the
5-11 causing of the following acts within this state are unlawful and
5-12 prohibited:
5-13 (a) the introduction or delivery for introduction into
5-14 commerce of any food, drug, device, or cosmetic that is adulterated
5-15 or misbranded;
5-16 (b) the adulteration or misbranding of any food, drug,
5-17 device, or cosmetic in commerce;
5-18 (c) the receipt in commerce of any food, drug, device, or
5-19 cosmetic that is adulterated or misbranded, and the delivery or
5-20 proffered delivery thereof for pay or otherwise;
5-21 (d) the distribution in commerce of a consumer commodity, if
5-22 such commodity is contained in a package, or if there is affixed to
5-23 that commodity a label that does not conform to the provisions of
5-24 this chapter and of rules adopted under the authority of this
5-25 chapter; provided, however, that this prohibition shall not apply
5-26 to persons engaged in business as wholesale or retail distributors
5-27 of consumer commodities except to the extent that such persons:
6-1 (1) are engaged in the packaging or labeling of such
6-2 commodities; or
6-3 (2) prescribe or specify by any means the manner in
6-4 which such commodities are packaged or labeled;
6-5 (e) the introduction or delivery for introduction into
6-6 commerce of any article in violation of Section 431.084, 431.114,
6-7 or 431.115;
6-8 (f) the dissemination of any false advertisement;
6-9 (g) the refusal to permit entry or inspection, or to permit
6-10 the taking of a sample or to permit access to or copying of any
6-11 record as authorized by Sections 431.042-431.044; or the failure to
6-12 establish or maintain any record or make any report required under
6-13 Section 512(j), (l), or (m) of the federal Act, or the refusal to
6-14 permit access to or verification or copying of any such required
6-15 record;
6-16 (h) the manufacture within this state of any food, drug,
6-17 device, or cosmetic that is adulterated or misbranded;
6-18 (i) the giving of a guaranty or undertaking referred to in
6-19 Section 431.059, which guaranty or undertaking is false, except by
6-20 a person who relied on a guaranty or undertaking to the same effect
6-21 signed by, and containing the name and address of the person
6-22 residing in this state from whom the person received in good faith
6-23 the food, drug, device, or cosmetic; or the giving of a guaranty or
6-24 undertaking referred to in Section 431.059, which guaranty or
6-25 undertaking is false;
6-26 (j) the use, removal, or disposal of a detained or embargoed
6-27 article in violation of Section 431.048;
7-1 (k) the alteration, mutilation, destruction, obliteration,
7-2 or removal of the whole or any part of the labeling of, or the
7-3 doing of any other act with respect to a food, drug, device, or
7-4 cosmetic, if such act is done while such article is held for sale
7-5 after shipment in commerce and results in such article being
7-6 adulterated or misbranded;
7-7 (l)(1) forging, counterfeiting, simulating, or falsely
7-8 representing, or without proper authority using any mark, stamp,
7-9 tag, label, or other identification device authorized or required
7-10 by rules adopted under this chapter or the regulations promulgated
7-11 under the provisions of the federal Act;
7-12 (2) making, selling, disposing of, or keeping in
7-13 possession, control, or custody, or concealing any punch, die,
7-14 plate, stone, or other thing designed to print, imprint, or
7-15 reproduce the trademark, trade name, or other identifying mark,
7-16 imprint, or device of another or any likeness of any of the
7-17 foregoing on any drug or container or labeling thereof so as to
7-18 render such drug a counterfeit drug;
7-19 (3) the doing of any act that causes a drug to be a
7-20 counterfeit drug, or the sale or dispensing, or the holding for
7-21 sale or dispensing, of a counterfeit drug;
7-22 (m) the using by any person to the person's own advantage,
7-23 or revealing, other than to the commissioner, an authorized agent,
7-24 a health authority or to the courts when relevant in any judicial
7-25 proceeding under this chapter, of any information acquired under
7-26 the authority of this chapter concerning any method or process that
7-27 as a trade secret is entitled to protection;
8-1 (n) the using, on the labeling of any drug or device or in
8-2 any advertising relating to such drug or device, of any
8-3 representation or suggestion that approval of an application with
8-4 respect to such drug or device is in effect under Section 431.114
8-5 or Section 505, 515, or 520(g) of the federal Act, as the case may
8-6 be, or that such drug or device complies with the provisions of
8-7 such sections;
8-8 (o) the using, in labeling, advertising or other sales
8-9 promotion of any reference to any report or analysis furnished in
8-10 compliance with Sections 431.042-431.044 or Section 704 of the
8-11 federal Act;
8-12 (p) in the case of a prescription drug distributed or
8-13 offered for sale in this state, the failure of the manufacturer,
8-14 packer, or distributor of the drug to maintain for transmittal, or
8-15 to transmit, to any practitioner licensed by applicable law to
8-16 administer such drug who makes written request for information as
8-17 to such drug, true and correct copies of all printed matter that is
8-18 required to be included in any package in which that drug is
8-19 distributed or sold, or such other printed matter as is approved
8-20 under the federal Act. Nothing in this subsection shall be
8-21 construed to exempt any person from any labeling requirement
8-22 imposed by or under other provisions of this chapter;
8-23 (q)(1) placing or causing to be placed on any drug or device
8-24 or container of any drug or device, with intent to defraud, the
8-25 trade name or other identifying mark, or imprint of another or any
8-26 likeness of any of the foregoing;
8-27 (2) selling, dispensing, disposing of or causing to be
9-1 sold, dispensed, or disposed of, or concealing or keeping in
9-2 possession, control, or custody, with intent to sell, dispense, or
9-3 dispose of, any drug, device, or any container of any drug or
9-4 device, with knowledge that the trade name or other identifying
9-5 mark or imprint of another or any likeness of any of the foregoing
9-6 has been placed thereon in a manner prohibited by Subdivision (1)
9-7 of this subsection; or
9-8 (3) making, selling, disposing of, causing to be made,
9-9 sold, or disposed of, keeping in possession, control, or custody,
9-10 or concealing with intent to defraud any punch, die, plate, stone,
9-11 or other thing designed to print, imprint, or reproduce the
9-12 trademark, trade name, or other identifying mark, imprint, or
9-13 device of another or any likeness of any of the foregoing on any
9-14 drug or container or labeling of any drug or container so as to
9-15 render such drug a counterfeit drug;
9-16 (r) dispensing or causing to be dispensed a different drug
9-17 in place of the drug ordered or prescribed without the express
9-18 permission in each case of the person ordering or prescribing;
9-19 (s) the failure to register in accordance with Section 510
9-20 of the federal Act, the failure to provide any information required
9-21 by Section 510(j) or (k) of the federal Act, or the failure to
9-22 provide a notice required by Section 510(j)(2) of the federal Act;
9-23 (t)(1) the failure or refusal to:
9-24 (A) comply with any requirement prescribed under
9-25 Section 518 or 520(g) of the federal Act; or
9-26 (B) furnish any notification or other material
9-27 or information required by or under Section 519 or 520(g) of the
10-1 federal Act;
10-2 (2) with respect to any device, the submission of any
10-3 report that is required by or under this chapter that is false or
10-4 misleading in any material respect;
10-5 (u) the movement of a device in violation of an order under
10-6 Section 304(g) of the federal Act or the removal or alteration of
10-7 any mark or label required by the order to identify the device as
10-8 detained;
10-9 (v) the failure to provide the notice required by Section
10-10 412(b) or 412(c), the failure to make the reports required by
10-11 Section 412(d)(1)(B), or the failure to meet the requirements
10-12 prescribed under Section 412(d)(2) of the federal Act;
10-13 (w) except as provided under Subchapter M, the acceptance by
10-14 a person of an unused prescription or drug, in whole or in part,
10-15 for the purpose of resale, after the prescription or drug has been
10-16 originally dispensed, or sold;
10-17 (x) engaging in the wholesale distribution of drugs or
10-18 operating as a distributor or manufacturer of devices in this state
10-19 without filing a licensing statement with the commissioner as
10-20 required by Section 431.202 or having a license as required by
10-21 Section 431.272, as applicable;
10-22 (y) engaging in the manufacture of food in this state
10-23 without first registering with the department as required by
10-24 Section 431.222; or
10-25 (z) unless approved by the United States Food and Drug
10-26 Administration pursuant to the federal Act, the sale, delivery,
10-27 holding, or offering for sale of a self-testing kit designed to
11-1 indicate whether a person has a human immunodeficiency virus
11-2 infection, acquired immune deficiency syndrome, or a related
11-3 disorder or condition.
11-4 SECTION 3. Subchapter M, Chapter 431, Health and Safety
11-5 Code, as added by this Act, and the change in law made by this Act
11-6 to Section 431.021, Health and Safety Code, take effect January 1,
11-7 2002. This Act takes effect September 1, 2001, for the limited
11-8 purpose of allowing the Texas Department of Health to adopt the
11-9 rules required under Section 431.324, Health and Safety Code, as
11-10 added by this Act, in time for the rules to take effect on January
11-11 1, 2002.
_______________________________ _______________________________
President of the Senate Speaker of the House
I certify that H.B. No. 2729 was passed by the House on May
5, 2001, by a non-record vote; and that the House concurred in
Senate amendments to H.B. No. 2729 on May 25, 2001, by a non-record
vote.
_______________________________
Chief Clerk of the House
I certify that H.B. No. 2729 was passed by the Senate, with
amendments, on May 22, 2001, by a viva-voce vote.
_______________________________
Secretary of the Senate
APPROVED: __________________________
Date
__________________________
Governor