By Madden H.B. No. 2695
77R1513 JRD-D
A BILL TO BE ENTITLED
1-1 AN ACT
1-2 relating to the return to the dispensing pharmacy of unused
1-3 prescription drugs for which the state paid all or part of the cost
1-4 by a convalescent or nursing home.
1-5 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
1-6 SECTION 1. Subchapter N, Chapter 242, Health and Safety Code,
1-7 is amended by adding Sections 242.6035, 242.6036, and 242.6037 to
1-8 read as follows:
1-9 Sec. 242.6035. RETURNING CERTAIN UNUSED MEDICATION. (a) An
1-10 institution shall, in accordance with this section, return to the
1-11 dispensing pharmacy certain medication that requires a prescription
1-12 and that will not be used by the resident for whom the medication
1-13 was dispensed if the state paid all or part of the cost of the
1-14 medication under the state Medicaid program or any other program.
1-15 (b) The dispensing pharmacy to which the medication is
1-16 returned may, in accordance with this section, redispense the
1-17 medication.
1-18 (c) An institution may return medication that requires a
1-19 prescription to the dispensing pharmacy under this section and the
1-20 dispensing pharmacy may redispense the medication under this
1-21 section only if the medication:
1-22 (1) is not a controlled substance under Chapter 481;
1-23 (2) is sealed in the manufacturer's unopened original
1-24 tamper-evident packaging; and
2-1 (3) is returned to the dispensing pharmacy in time for
2-2 the medication to be redispensed by the pharmacy either before the
2-3 expiration date or within the recommended shelf life of the
2-4 medication, as applicable.
2-5 (d) An institution that returns medication under this
2-6 section shall use appropriate safeguards to ensure that the
2-7 medication is not compromised or illegally diverted during its
2-8 return.
2-9 Sec. 242.6036. REIMBURSEMENT FOR RETURNED UNUSED MEDICATION.
2-10 (a) This section applies only in relation to unused medication
2-11 returned under Section 242.6035.
2-12 (b) A person who was paid by the state for the medication
2-13 shall pay or credit the state, on the return of the medication to
2-14 the dispensing pharmacy, for the full amount that the state paid
2-15 for the medication.
2-16 (c) If the state paid the returning institution for the
2-17 medication, the institution may deduct from the amount it pays or
2-18 credits the state under this section a reasonable amount not to
2-19 exceed the actual cost incurred by the institution in returning
2-20 the medication to the dispensing pharmacy. If the state paid the
2-21 dispensing pharmacy for the medication, the dispensing pharmacy may
2-22 deduct from the amount it pays or credits the state under this
2-23 section a reasonable amount not to exceed the actual cost incurred
2-24 by the dispensing pharmacy in originally sending the medication to
2-25 the institution.
2-26 (d) To the extent possible, the department and the Health
2-27 and Human Services Commission shall ensure that the state's claims
3-1 for reimbursement under this section are adjudicated and paid or
3-2 credited electronically, especially when the state paid for the
3-3 medication electronically.
3-4 Sec. 242.6037. RULES; PROCEDURES; RECORDKEEPING. (a) This
3-5 section applies only in relation to unused medication returned
3-6 under Section 242.6035 and in relation to reimbursement under
3-7 Section 242.6036.
3-8 (b) An institution or dispensing pharmacy affected by
3-9 Sections 242.6035 and 242.6036 shall establish procedures necessary
3-10 to allow the institution or dispensing pharmacy to effectively and
3-11 efficiently comply with those laws and with applicable rules
3-12 adopted by a state agency under this section.
3-13 (c) An institution or dispensing pharmacy affected by
3-14 Sections 242.6035 and 242.6036 shall keep accurate records relating
3-15 to returned medications in the manner and for the period prescribed
3-16 by rule of the Texas State Board of Pharmacy, including records
3-17 regarding amounts charged, paid, or received in connection with the
3-18 returned medication.
3-19 (d) The Texas State Board Of Pharmacy shall adopt rules to
3-20 implement this section and Sections 242.6035 and 242.6036 that are
3-21 necessary to protect the public health, safety, and welfare. The
3-22 rules must address:
3-23 (1) records that an institution or dispensing pharmacy
3-24 must keep under Subsection (c), including records that will allow
3-25 the appropriate authorities to determine whether returned
3-26 medication is redispensed safely and by legal and appropriate
3-27 means; and
4-1 (2) in appropriate detail, situations in which it is
4-2 normally presumed to be safe and allowed and situations in which it
4-3 is presumed to be unsafe and not allowed for a pharmacy to
4-4 redispense medications returned under Section 242.6035, including
4-5 situations in which medications may not be redispensed because
4-6 there is reason to believe the medication could be subpotent or
4-7 could have been compromised or illegally diverted.
4-8 (e) The department shall adopt rules to ensure that each
4-9 institution establishes appropriate procedures necessary to allow
4-10 the institution to effectively and efficiently comply with this
4-11 section, Sections 242.6035 and 242.6036, and applicable rules
4-12 adopted by a state agency under this section. The rules must
4-13 address procedures by which an institution may effectively identify
4-14 medication for which the state paid all or part of the cost and
4-15 which the institution has a duty to return under Section 242.6035.
4-16 (f) The Health and Human Services Commission, or the
4-17 department at the direction of the commission, shall adopt rules to
4-18 ensure that the state is promptly and efficiently paid or credited
4-19 the correct amount for returned medications for which the state
4-20 paid all or part of the cost.
4-21 SECTION 2. Section 431.021, Health and Safety Code, is
4-22 amended to read as follows:
4-23 Sec. 431.021. PROHIBITED ACTS. The following acts and the
4-24 causing of the following acts within this state are unlawful and
4-25 prohibited:
4-26 (a) the introduction or delivery for introduction into
4-27 commerce of any food, drug, device, or cosmetic that is adulterated
5-1 or misbranded;
5-2 (b) the adulteration or misbranding of any food, drug,
5-3 device, or cosmetic in commerce;
5-4 (c) the receipt in commerce of any food, drug, device,
5-5 or cosmetic that is adulterated or misbranded, and the delivery or
5-6 proffered delivery thereof for pay or otherwise;
5-7 (d) the distribution in commerce of a consumer
5-8 commodity, if such commodity is contained in a package, or if there
5-9 is affixed to that commodity a label that does not conform to the
5-10 provisions of this chapter and of rules adopted under the authority
5-11 of this chapter; provided, however, that this prohibition shall not
5-12 apply to persons engaged in business as wholesale or retail
5-13 distributors of consumer commodities except to the extent that such
5-14 persons:
5-15 (1) are engaged in the packaging or labeling of
5-16 such commodities; or
5-17 (2) prescribe or specify by any means the manner
5-18 in which such commodities are packaged or labeled;
5-19 (e) the introduction or delivery for introduction into
5-20 commerce of any article in violation of Section 431.084, 431.114,
5-21 or 431.115;
5-22 (f) the dissemination of any false advertisement;
5-23 (g) the refusal to permit entry or inspection, or to
5-24 permit the taking of a sample or to permit access to or copying of
5-25 any record as authorized by Sections 431.042-431.044; or the
5-26 failure to establish or maintain any record or make any report
5-27 required under Section 512(j), (l), or (m) of the federal Act, or
6-1 the refusal to permit access to or verification or copying of any
6-2 such required record;
6-3 (h) the manufacture within this state of any food,
6-4 drug, device, or cosmetic that is adulterated or misbranded;
6-5 (i) the giving of a guaranty or undertaking referred
6-6 to in Section 431.059, which guaranty or undertaking is false,
6-7 except by a person who relied on a guaranty or undertaking to the
6-8 same effect signed by, and containing the name and address of the
6-9 person residing in this state from whom the person received in good
6-10 faith the food, drug, device, or cosmetic; or the giving of a
6-11 guaranty or undertaking referred to in Section 431.059, which
6-12 guaranty or undertaking is false;
6-13 (j) the use, removal, or disposal of a detained or
6-14 embargoed article in violation of Section 431.048;
6-15 (k) the alteration, mutilation, destruction,
6-16 obliteration, or removal of the whole or any part of the labeling
6-17 of, or the doing of any other act with respect to a food, drug,
6-18 device, or cosmetic, if such act is done while such article is held
6-19 for sale after shipment in commerce and results in such article
6-20 being adulterated or misbranded;
6-21 (l)(1) forging, counterfeiting, simulating, or falsely
6-22 representing, or without proper authority using any mark, stamp,
6-23 tag, label, or other identification device authorized or required
6-24 by rules adopted under this chapter or the regulations promulgated
6-25 under the provisions of the federal Act;
6-26 (2) making, selling, disposing of, or keeping in
6-27 possession, control, or custody, or concealing any punch, die,
7-1 plate, stone, or other thing designed to print, imprint, or
7-2 reproduce the trademark, trade name, or other identifying mark,
7-3 imprint, or device of another or any likeness of any of the
7-4 foregoing on any drug or container or labeling thereof so as to
7-5 render such drug a counterfeit drug;
7-6 (3) the doing of any act that causes a drug to
7-7 be a counterfeit drug, or the sale or dispensing, or the holding
7-8 for sale or dispensing, of a counterfeit drug;
7-9 (m) the using by any person to the person's own
7-10 advantage, or revealing, other than to the commissioner, an
7-11 authorized agent, a health authority or to the courts when relevant
7-12 in any judicial proceeding under this chapter, of any information
7-13 acquired under the authority of this chapter concerning any method
7-14 or process that as a trade secret is entitled to protection;
7-15 (n) the using, on the labeling of any drug or device
7-16 or in any advertising relating to such drug or device, of any
7-17 representation or suggestion that approval of an application with
7-18 respect to such drug or device is in effect under Section 431.114
7-19 or Section 505, 515, or 520(g) of the federal Act, as the case may
7-20 be, or that such drug or device complies with the provisions of
7-21 such sections;
7-22 (o) the using, in labeling, advertising or other sales
7-23 promotion of any reference to any report or analysis furnished in
7-24 compliance with Sections 431.042-431.044 or Section 704 of the
7-25 federal Act;
7-26 (p) in the case of a prescription drug distributed or
7-27 offered for sale in this state, the failure of the manufacturer,
8-1 packer, or distributor of the drug to maintain for transmittal, or
8-2 to transmit, to any practitioner licensed by applicable law to
8-3 administer such drug who makes written request for information as
8-4 to such drug, true and correct copies of all printed matter that is
8-5 required to be included in any package in which that drug is
8-6 distributed or sold, or such other printed matter as is approved
8-7 under the federal Act. Nothing in this subsection shall be
8-8 construed to exempt any person from any labeling requirement
8-9 imposed by or under other provisions of this chapter;
8-10 (q)(1) placing or causing to be placed on any drug or
8-11 device or container of any drug or device, with intent to defraud,
8-12 the trade name or other identifying mark, or imprint of another or
8-13 any likeness of any of the foregoing;
8-14 (2) selling, dispensing, disposing of or causing
8-15 to be sold, dispensed, or disposed of, or concealing or keeping in
8-16 possession, control, or custody, with intent to sell, dispense, or
8-17 dispose of, any drug, device, or any container of any drug or
8-18 device, with knowledge that the trade name or other identifying
8-19 mark or imprint of another or any likeness of any of the foregoing
8-20 has been placed thereon in a manner prohibited by Subdivision (1)
8-21 of this subsection; or
8-22 (3) making, selling, disposing of, causing to be
8-23 made, sold, or disposed of, keeping in possession, control, or
8-24 custody, or concealing with intent to defraud any punch, die,
8-25 plate, stone, or other thing designed to print, imprint, or
8-26 reproduce the trademark, trade name, or other identifying mark,
8-27 imprint, or device of another or any likeness of any of the
9-1 foregoing on any drug or container or labeling of any drug or
9-2 container so as to render such drug a counterfeit drug;
9-3 (r) dispensing or causing to be dispensed a different
9-4 drug in place of the drug ordered or prescribed without the express
9-5 permission in each case of the person ordering or prescribing;
9-6 (s) the failure to register in accordance with Section
9-7 510 of the federal Act, the failure to provide any information
9-8 required by Section 510(j) or (k) of the federal Act, or the
9-9 failure to provide a notice required by Section 510(j)(2) of the
9-10 federal Act;
9-11 (t)(1) the failure or refusal to:
9-12 (A) comply with any requirement prescribed
9-13 under Section 518 or 520(g) of the federal Act; or
9-14 (B) furnish any notification or other
9-15 material or information required by or under Section 519 or 520(g)
9-16 of the federal Act;
9-17 (2) with respect to any device, the submission
9-18 of any report that is required by or under this chapter that is
9-19 false or misleading in any material respect;
9-20 (u) the movement of a device in violation of an order
9-21 under Section 304(g) of the federal Act or the removal or
9-22 alteration of any mark or label required by the order to identify
9-23 the device as detained;
9-24 (v) the failure to provide the notice required by
9-25 Section 412(b) or 412(c), the failure to make the reports required
9-26 by Section 412(d)(1)(B), or the failure to meet the requirements
9-27 prescribed under Section 412(d)(2) of the federal Act;
10-1 (w) except as provided under Sections 242.6035,
10-2 242.6036, and 242.6037, the acceptance by a person of an unused
10-3 prescription or drug, in whole or in part, for the purpose of
10-4 resale, after the prescription or drug has been originally
10-5 dispensed, or sold;
10-6 (x) engaging in the wholesale distribution of drugs or
10-7 operating as a distributor or manufacturer of devices in this state
10-8 without filing a licensing statement with the commissioner as
10-9 required by Section 431.202 or having a license as required by
10-10 Section 431.272, as applicable;
10-11 (y) engaging in the manufacture of food in this state
10-12 without first registering with the department as required by
10-13 Section 431.222; or
10-14 (z) unless approved by the United States Food and Drug
10-15 Administration pursuant to the federal Act, the sale, delivery,
10-16 holding, or offering for sale of a self-testing kit designed to
10-17 indicate whether a person has a human immunodeficiency virus
10-18 infection, acquired immune deficiency syndrome, or a related
10-19 disorder or condition.
10-20 SECTION 3. Sections 242.6035, 242.6036, and 242.6037, Health
10-21 and Safety Code, as added by this Act, and the change in law made
10-22 by this Act to Section 431.021, Health and Safety Code, take effect
10-23 January 1, 2002. This Act takes effect September 1, 2001, for the
10-24 limited purpose of allowing the Texas State Board of Pharmacy, the
10-25 Texas Department of Human Services, and, if applicable, the Health
10-26 and Human Services Commission to timely adopt the rules required
10-27 under Section 242.6037, Health and Safety Code, as added by this
11-1 Act. Those agencies shall adopt the required rules in time for the
11-2 rules to take effect on January 1, 2002.