By Gray H.B. No. 2729
77R2389 JRD-D
A BILL TO BE ENTITLED
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 by
1-6 adding Subchapter M to read as follows:
1-7 SUBCHAPTER M. DRUG DONATION PROGRAM
1-8 Sec. 431.321. DEFINITION. In this subchapter, "charitable
1-9 medical clinic" means a clinic that provides medical care without
1-10 charge or for a substantially reduced charge.
1-11 Sec. 431.322. DONATION OF UNUSED DRUGS TO CHARITABLE MEDICAL
1-12 CLINIC. (a) A convalescent or nursing home or related institution,
1-13 hospice, hospital, physician, pharmacy, or individual may donate
1-14 certain unused prescription drugs to a charitable medical clinic,
1-15 and a charitable medical clinic may accept and dispense or
1-16 administer the donated drugs, in accordance with this subchapter.
1-17 (b) The donor shall use appropriate safeguards to ensure
1-18 that the drugs are not compromised or illegally diverted while
1-19 being stored or transported to the charitable medical clinic.
1-20 (c) The charitable medical clinic may not accept the donated
1-21 drugs unless:
1-22 (1) the donor certifies that the drugs have been
1-23 properly stored while in the possession of the donor or of the
1-24 person for whom the drugs were originally dispensed;
2-1 (2) the donor provides the clinic with a verifiable
2-2 address and telephone number; and
2-3 (3) the person transferring possession of the drugs
2-4 presents the clinic with photographic identification.
2-5 Sec. 431.323. CIRCUMSTANCES UNDER WHICH DONATED DRUGS MAY BE
2-6 ACCEPTED AND DISPENSED. (a) A charitable medical clinic may accept
2-7 and dispense or administer donated drugs only in accordance with
2-8 this section.
2-9 (b) The donated drugs must be drugs that require a
2-10 prescription. A donated drug may not be a controlled substance
2-11 under Chapter 481.
2-12 (c) The donated drugs must:
2-13 (1) be sealed in the manufacturer's unopened original
2-14 tamper-evident packaging and either:
2-15 (A) individually packaged; or
2-16 (B) packaged in unit-dose packaging;
2-17 (2) be oral or parenteral medication in sealed
2-18 single-dose containers approved by the federal Food and Drug
2-19 Administration;
2-20 (3) be topical or inhalant drugs in sealed
2-21 units-of-use containers approved by the federal Food and Drug
2-22 Administration; or
2-23 (4) be parenteral medication in sealed multiple-dose
2-24 containers approved by the federal Food and Drug Administration
2-25 from which no doses have been withdrawn.
2-26 (d) The charitable medical clinic may dispense or administer
2-27 the donated drugs only:
3-1 (1) before the expiration date or within the
3-2 recommended shelf life of the donated drugs, as applicable; and
3-3 (2) after a licensed pharmacist has determined that
3-4 the drugs are of an acceptable integrity.
3-5 (e) The donated drugs may be accepted and dispensed or
3-6 administered by the charitable medical clinic only in accordance
3-7 with rules adopted by the department.
3-8 Sec. 431.324. RULES. The department shall adopt rules to
3-9 implement this subchapter that are designed to protect the public
3-10 health and safety.
3-11 Sec. 431.325. LIMITATION ON LIABILITY. A person may be held
3-12 civilly liable in connection with the donation of drugs under this
3-13 subchapter, and a charitable medical clinic and its physicians,
3-14 nurses, pharmacists, or other personnel may be held civilly liable
3-15 because of accepting and dispensing or administering drugs donated
3-16 under this subchapter, only for an act or omission that is wilfully
3-17 or wantonly negligent, done with conscious indifference or reckless
3-18 disregard for the safety of others, or done with the intent to harm
3-19 another.
3-20 SECTION 2. Section 431.021, Health and Safety Code, is
3-21 amended to read as follows:
3-22 Sec. 431.021. PROHIBITED ACTS. The following acts and the
3-23 causing of the following acts within this state are unlawful and
3-24 prohibited:
3-25 (a) the introduction or delivery for introduction into
3-26 commerce of any food, drug, device, or cosmetic that is adulterated
3-27 or misbranded;
4-1 (b) the adulteration or misbranding of any food, drug,
4-2 device, or cosmetic in commerce;
4-3 (c) the receipt in commerce of any food, drug, device,
4-4 or cosmetic that is adulterated or misbranded, and the delivery or
4-5 proffered delivery thereof for pay or otherwise;
4-6 (d) the distribution in commerce of a consumer
4-7 commodity, if such commodity is contained in a package, or if there
4-8 is affixed to that commodity a label that does not conform to the
4-9 provisions of this chapter and of rules adopted under the authority
4-10 of this chapter; provided, however, that this prohibition shall not
4-11 apply to persons engaged in business as wholesale or retail
4-12 distributors of consumer commodities except to the extent that such
4-13 persons:
4-14 (1) are engaged in the packaging or labeling of
4-15 such commodities; or
4-16 (2) prescribe or specify by any means the manner
4-17 in which such commodities are packaged or labeled;
4-18 (e) the introduction or delivery for introduction into
4-19 commerce of any article in violation of Section 431.084, 431.114,
4-20 or 431.115;
4-21 (f) the dissemination of any false advertisement;
4-22 (g) the refusal to permit entry or inspection, or to
4-23 permit the taking of a sample or to permit access to or copying of
4-24 any record as authorized by Sections 431.042-431.044; or the
4-25 failure to establish or maintain any record or make any report
4-26 required under Section 512(j), (l), or (m) of the federal Act, or
4-27 the refusal to permit access to or verification or copying of any
5-1 such required record;
5-2 (h) the manufacture within this state of any food,
5-3 drug, device, or cosmetic that is adulterated or misbranded;
5-4 (i) the giving of a guaranty or undertaking referred
5-5 to in Section 431.059, which guaranty or undertaking is false,
5-6 except by a person who relied on a guaranty or undertaking to the
5-7 same effect signed by, and containing the name and address of the
5-8 person residing in this state from whom the person received in good
5-9 faith the food, drug, device, or cosmetic; or the giving of a
5-10 guaranty or undertaking referred to in Section 431.059, which
5-11 guaranty or undertaking is false;
5-12 (j) the use, removal, or disposal of a detained or
5-13 embargoed article in violation of Section 431.048;
5-14 (k) the alteration, mutilation, destruction,
5-15 obliteration, or removal of the whole or any part of the labeling
5-16 of, or the doing of any other act with respect to a food, drug,
5-17 device, or cosmetic, if such act is done while such article is held
5-18 for sale after shipment in commerce and results in such article
5-19 being adulterated or misbranded;
5-20 (l)(1) forging, counterfeiting, simulating, or falsely
5-21 representing, or without proper authority using any mark, stamp,
5-22 tag, label, or other identification device authorized or required
5-23 by rules adopted under this chapter or the regulations promulgated
5-24 under the provisions of the federal Act;
5-25 (2) making, selling, disposing of, or keeping in
5-26 possession, control, or custody, or concealing any punch, die,
5-27 plate, stone, or other thing designed to print, imprint, or
6-1 reproduce the trademark, trade name, or other identifying mark,
6-2 imprint, or device of another or any likeness of any of the
6-3 foregoing on any drug or container or labeling thereof so as to
6-4 render such drug a counterfeit drug;
6-5 (3) the doing of any act that causes a drug to
6-6 be a counterfeit drug, or the sale or dispensing, or the holding
6-7 for sale or dispensing, of a counterfeit drug;
6-8 (m) the using by any person to the person's own
6-9 advantage, or revealing, other than to the commissioner, an
6-10 authorized agent, a health authority or to the courts when relevant
6-11 in any judicial proceeding under this chapter, of any information
6-12 acquired under the authority of this chapter concerning any method
6-13 or process that as a trade secret is entitled to protection;
6-14 (n) the using, on the labeling of any drug or device
6-15 or in any advertising relating to such drug or device, of any
6-16 representation or suggestion that approval of an application with
6-17 respect to such drug or device is in effect under Section 431.114
6-18 or Section 505, 515, or 520(g) of the federal Act, as the case may
6-19 be, or that such drug or device complies with the provisions of
6-20 such sections;
6-21 (o) the using, in labeling, advertising or other sales
6-22 promotion of any reference to any report or analysis furnished in
6-23 compliance with Sections 431.042-431.044 or Section 704 of the
6-24 federal Act;
6-25 (p) in the case of a prescription drug distributed or
6-26 offered for sale in this state, the failure of the manufacturer,
6-27 packer, or distributor of the drug to maintain for transmittal, or
7-1 to transmit, to any practitioner licensed by applicable law to
7-2 administer such drug who makes written request for information as
7-3 to such drug, true and correct copies of all printed matter that is
7-4 required to be included in any package in which that drug is
7-5 distributed or sold, or such other printed matter as is approved
7-6 under the federal Act. Nothing in this subsection shall be
7-7 construed to exempt any person from any labeling requirement
7-8 imposed by or under other provisions of this chapter;
7-9 (q)(1) placing or causing to be placed on any drug or
7-10 device or container of any drug or device, with intent to defraud,
7-11 the trade name or other identifying mark, or imprint of another or
7-12 any likeness of any of the foregoing;
7-13 (2) selling, dispensing, disposing of or causing
7-14 to be sold, dispensed, or disposed of, or concealing or keeping in
7-15 possession, control, or custody, with intent to sell, dispense, or
7-16 dispose of, any drug, device, or any container of any drug or
7-17 device, with knowledge that the trade name or other identifying
7-18 mark or imprint of another or any likeness of any of the foregoing
7-19 has been placed thereon in a manner prohibited by Subdivision (1)
7-20 of this subsection; or
7-21 (3) making, selling, disposing of, causing to be
7-22 made, sold, or disposed of, keeping in possession, control, or
7-23 custody, or concealing with intent to defraud any punch, die,
7-24 plate, stone, or other thing designed to print, imprint, or
7-25 reproduce the trademark, trade name, or other identifying mark,
7-26 imprint, or device of another or any likeness of any of the
7-27 foregoing on any drug or container or labeling of any drug or
8-1 container so as to render such drug a counterfeit drug;
8-2 (r) dispensing or causing to be dispensed a different
8-3 drug in place of the drug ordered or prescribed without the express
8-4 permission in each case of the person ordering or prescribing;
8-5 (s) the failure to register in accordance with Section
8-6 510 of the federal Act, the failure to provide any information
8-7 required by Section 510(j) or (k) of the federal Act, or the
8-8 failure to provide a notice required by Section 510(j)(2) of the
8-9 federal Act;
8-10 (t)(1) the failure or refusal to:
8-11 (A) comply with any requirement prescribed
8-12 under Section 518 or 520(g) of the federal Act; or
8-13 (B) furnish any notification or other
8-14 material or information required by or under Section 519 or 520(g)
8-15 of the federal Act;
8-16 (2) with respect to any device, the submission
8-17 of any report that is required by or under this chapter that is
8-18 false or misleading in any material respect;
8-19 (u) the movement of a device in violation of an order
8-20 under Section 304(g) of the federal Act or the removal or
8-21 alteration of any mark or label required by the order to identify
8-22 the device as detained;
8-23 (v) the failure to provide the notice required by
8-24 Section 412(b) or 412(c), the failure to make the reports required
8-25 by Section 412(d)(1)(B), or the failure to meet the requirements
8-26 prescribed under Section 412(d)(2) of the federal Act;
8-27 (w) except as provided under Subchapter M, the
9-1 acceptance by a person of an unused prescription or drug, in whole
9-2 or in part, for the purpose of resale, after the prescription or
9-3 drug has been originally dispensed, or sold;
9-4 (x) engaging in the wholesale distribution of drugs or
9-5 operating as a distributor or manufacturer of devices in this state
9-6 without filing a licensing statement with the commissioner as
9-7 required by Section 431.202 or having a license as required by
9-8 Section 431.272, as applicable;
9-9 (y) engaging in the manufacture of food in this state
9-10 without first registering with the department as required by
9-11 Section 431.222; or
9-12 (z) unless approved by the United States Food and Drug
9-13 Administration pursuant to the federal Act, the sale, delivery,
9-14 holding, or offering for sale of a self-testing kit designed to
9-15 indicate whether a person has a human immunodeficiency virus
9-16 infection, acquired immune deficiency syndrome, or a related
9-17 disorder or condition.
9-18 SECTION 3. Subchapter M, Chapter 431, Health and Safety Code,
9-19 as added by this Act, and the change in law made by this Act to
9-20 Section 431.021, Health and Safety Code, take effect January 1,
9-21 2002. This Act takes effect September 1, 2001, for the limited
9-22 purpose of allowing the Texas Department of Health to adopt the
9-23 rules required under Section 431.324, Health and Safety Code, as
9-24 added by this Act, in time for the rules to take effect on January
9-25 1, 2002.