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H.B. No. 3486
AN ACT
relating to a health care facility's return of certain unused drugs
to a pharmacy and to reimbursement or credit under the state's
medical assistance program for returned drugs.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. Subchapter C, Chapter 562, Occupations Code, is
amended by adding Sections 562.1085 and 562.1086 to read as
follows:
Sec. 562.1085. UNUSED DRUGS RETURNED BY CERTAIN
PHARMACISTS. (a) A pharmacist who practices in or serves as a
consultant for a health care facility in this state may return to a
pharmacy certain unused drugs, other than a controlled substance as
defined by Chapter 481, Health and Safety Code, purchased from the
pharmacy as provided by board rule. The unused drugs must:
(1) be approved by the federal Food and Drug
Administration and be:
(A) sealed in the manufacturer's original
unopened tamper-evident packaging and either individually packaged
or packaged in unit-dose packaging;
(B) oral or parenteral medications in sealed
single-dose containers approved by the federal Food and Drug
Administration;
(C) topical or inhalant drugs in sealed
units-of-use containers approved by the federal Food and Drug
Administration; or
(D) parenteral medications in sealed
multiple-dose containers approved by the federal Food and Drug
Administration from which doses have not been withdrawn; and
(2) not be the subject of a mandatory recall by a state
or federal agency or a voluntary recall by a drug seller or
manufacturer.
(b) A pharmacist for the pharmacy shall examine a drug
returned under this section to ensure the integrity of the drug
product. A health care facility may not return a drug that:
(1) has been compounded;
(2) appears on inspection to be adulterated;
(3) requires refrigeration; or
(4) has less than 120 days until the expiration date or
end of the shelf life.
(c) The pharmacy may restock and redistribute unused drugs
returned under this section.
(d) The pharmacy shall reimburse or credit the state
Medicaid program for an unused drug returned under this section.
(e) The board shall adopt the rules, policies, and
procedures necessary to administer this section, including rules
that require a health care facility to inform the Health and Human
Services Commission of drugs returned to a pharmacy under this
section.
Sec. 562.1086. LIMITATION ON LIABILITY. (a) A pharmacist
that returns unused drugs or the health care facility at which the
pharmacist practices or serves and a pharmacy that accepts the
unused drugs under Section 562.1085 and the employees of the
pharmacist, health care facility, or pharmacy are not liable for
harm caused by the accepting, dispensing, or administering of drugs
returned in strict compliance with Section 562.1085 unless the harm
is caused by:
(1) wilful or wanton acts of negligence;
(2) conscious indifference or reckless disregard for
the safety of others; or
(3) intentional conduct.
(b) This section does not limit, or in any way affect or
diminish, the liability of a drug seller or manufacturer under
Chapter 82, Civil Practice and Remedies Code.
(c) This section does not apply if harm results from the
failure to fully and completely comply with the requirements of
Section 562.1085.
SECTION 2. Section 431.021, Health and Safety Code, is
amended to read as follows:
Sec. 431.021. PROHIBITED ACTS. The following acts and the
causing of the following acts within this state are unlawful and
prohibited:
(a) the introduction or delivery for introduction into
commerce of any food, drug, device, or cosmetic that is adulterated
or misbranded;
(b) the adulteration or misbranding of any food, drug,
device, or cosmetic in commerce;
(c) the receipt in commerce of any food, drug, device,
or cosmetic that is adulterated or misbranded, and the delivery or
proffered delivery thereof for pay or otherwise;
(d) the distribution in commerce of a consumer
commodity, if such commodity is contained in a package, or if there
is affixed to that commodity a label that does not conform to the
provisions of this chapter and of rules adopted under the authority
of this chapter; provided, however, that this prohibition shall not
apply to persons engaged in business as wholesale or retail
distributors of consumer commodities except to the extent that such
persons:
(1) are engaged in the packaging or labeling of
such commodities; or
(2) prescribe or specify by any means the manner
in which such commodities are packaged or labeled;
(e) the introduction or delivery for introduction into
commerce of any article in violation of Section 431.084, 431.114,
or 431.115;
(f) the dissemination of any false advertisement;
(g) the refusal to permit entry or inspection, or to
permit the taking of a sample or to permit access to or copying of
any record as authorized by Sections 431.042-431.044; or the
failure to establish or maintain any record or make any report
required under Section 512(j), (l), or (m) of the federal Act, or
the refusal to permit access to or verification or copying of any
such required record;
(h) the manufacture within this state of any food,
drug, device, or cosmetic that is adulterated or misbranded;
(i) the giving of a guaranty or undertaking referred
to in Section 431.059, which guaranty or undertaking is false,
except by a person who relied on a guaranty or undertaking to the
same effect signed by, and containing the name and address of the
person residing in this state from whom the person received in good
faith the food, drug, device, or cosmetic; or the giving of a
guaranty or undertaking referred to in Section 431.059, which
guaranty or undertaking is false;
(j) the use, removal, or disposal of a detained or
embargoed article in violation of Section 431.048;
(k) the alteration, mutilation, destruction,
obliteration, or removal of the whole or any part of the labeling
of, or the doing of any other act with respect to a food, drug,
device, or cosmetic, if such act is done while such article is held
for sale after shipment in commerce and results in such article
being adulterated or misbranded;
(l)(1) forging, counterfeiting, simulating, or
falsely representing, or without proper authority using any mark,
stamp, tag, label, or other identification device authorized or
required by rules adopted under this chapter or the regulations
promulgated under the provisions of the federal Act;
(2) making, selling, disposing of, or keeping in
possession, control, or custody, or concealing any punch, die,
plate, stone, or other thing designed to print, imprint, or
reproduce the trademark, trade name, or other identifying mark,
imprint, or device of another or any likeness of any of the
foregoing on any drug or container or labeling thereof so as to
render such drug a counterfeit drug;
(3) the doing of any act that causes a drug to be
a counterfeit drug, or the sale or dispensing, or the holding for
sale or dispensing, of a counterfeit drug;
(m) the using by any person to the person's own
advantage, or revealing, other than to the commissioner, an
authorized agent, a health authority or to the courts when relevant
in any judicial proceeding under this chapter, of any information
acquired under the authority of this chapter concerning any method
or process that as a trade secret is entitled to protection;
(n) the using, on the labeling of any drug or device or
in any advertising relating to such drug or device, of any
representation or suggestion that approval of an application with
respect to such drug or device is in effect under Section 431.114 or
Section 505, 515, or 520(g) of the federal Act, as the case may be,
or that such drug or device complies with the provisions of such
sections;
(o) the using, in labeling, advertising or other sales
promotion of any reference to any report or analysis furnished in
compliance with Sections 431.042-431.044 or Section 704 of the
federal Act;
(p) in the case of a prescription drug distributed or
offered for sale in this state, the failure of the manufacturer,
packer, or distributor of the drug to maintain for transmittal, or
to transmit, to any practitioner licensed by applicable law to
administer such drug who makes written request for information as
to such drug, true and correct copies of all printed matter that is
required to be included in any package in which that drug is
distributed or sold, or such other printed matter as is approved
under the federal Act. Nothing in this subsection shall be
construed to exempt any person from any labeling requirement
imposed by or under other provisions of this chapter;
(q)(1) placing or causing to be placed on any drug or
device or container of any drug or device, with intent to defraud,
the trade name or other identifying mark, or imprint of another or
any likeness of any of the foregoing;
(2) selling, dispensing, disposing of or causing
to be sold, dispensed, or disposed of, or concealing or keeping in
possession, control, or custody, with intent to sell, dispense, or
dispose of, any drug, device, or any container of any drug or
device, with knowledge that the trade name or other identifying
mark or imprint of another or any likeness of any of the foregoing
has been placed thereon in a manner prohibited by Subdivision (1) of
this subsection; or
(3) making, selling, disposing of, causing to be
made, sold, or disposed of, keeping in possession, control, or
custody, or concealing with intent to defraud any punch, die,
plate, stone, or other thing designed to print, imprint, or
reproduce the trademark, trade name, or other identifying mark,
imprint, or device of another or any likeness of any of the
foregoing on any drug or container or labeling of any drug or
container so as to render such drug a counterfeit drug;
(r) dispensing or causing to be dispensed a different
drug in place of the drug ordered or prescribed without the express
permission in each case of the person ordering or prescribing;
(s) the failure to register in accordance with Section
510 of the federal Act, the failure to provide any information
required by Section 510(j) or (k) of the federal Act, or the failure
to provide a notice required by Section 510(j)(2) of the federal
Act;
(t)(1) the failure or refusal to:
(A) comply with any requirement prescribed
under Section 518 or 520(g) of the federal Act; or
(B) furnish any notification or other
material or information required by or under Section 519 or 520(g)
of the federal Act;
(2) with respect to any device, the submission of
any report that is required by or under this chapter that is false
or misleading in any material respect;
(u) the movement of a device in violation of an order
under Section 304(g) of the federal Act or the removal or alteration
of any mark or label required by the order to identify the device as
detained;
(v) the failure to provide the notice required by
Section 412(b) or 412(c), the failure to make the reports required
by Section 412(d)(1)(B), or the failure to meet the requirements
prescribed under Section 412(d)(2) of the federal Act;
(w) except as provided under Subchapter M of this
chapter and Section 562.1085, Occupations Code, the acceptance by a
person of an unused prescription or drug, in whole or in part, for
the purpose of resale, after the prescription or drug has been
originally dispensed, or sold;
(x) engaging in the wholesale distribution of drugs or
operating as a distributor or manufacturer of devices in this state
without filing a licensing statement with the commissioner as
required by Section 431.202 or having a license as required by
Section 431.272, as applicable;
(y) engaging in the manufacture of food in this state
or operating as a food wholesaler in this state without having a
license as required by Section 431.222; or
(z) unless approved by the United States Food and Drug
Administration pursuant to the federal Act, the sale, delivery,
holding, or offering for sale of a self-testing kit designed to
indicate whether a person has a human immunodeficiency virus
infection, acquired immune deficiency syndrome, or a related
disorder or condition.
SECTION 3. Section 32.028, Human Resources Code, is amended
by adding Subsections (i), (j), and (k) to read as follows:
(i) The Health and Human Services Commission shall adopt
rules governing the determination of the amount of reimbursement or
credit for restocking drugs under Section 562.1085, Occupations
Code, that recognize the costs of processing the drugs, including
the cost of:
(1) reporting the drug's prescription number and date
of original issue;
(2) verifying whether the drug's expiration date or
the drug's recommended shelf life exceeds 120 days;
(3) determining the source of payment; and
(4) preparing credit records.
(j) The commission shall provide an electronic system for
the issuance of credit for returned drugs that complies with the
Health Insurance Portability and Accountability Act of 1996 (Pub.
L. No. 104-191), as amended. To ensure a cost-effective system,
only drugs for which the credit exceeds the cost of the restocking
fee by at least 100 percent are eligible for credit.
(k) The commission shall establish a task force to develop
the rules necessary to implement Subsections (i) and (j). The task
force must include representatives of nursing facilities and
pharmacies.
SECTION 4. If before implementing any provision of this Act
a state agency determines that a waiver or authorization from a
federal agency is necessary for implementation of that provision,
the agency affected by the provision shall request the waiver or
authorization and may delay implementing that provision until the
waiver or authorization is granted.
SECTION 5. The Health and Human Services Commission shall
adopt the rules required by Sections 32.028(i) and (j), Human
Resources Code, as added by this Act, not later than December 1,
2003.
SECTION 6. (a) The Texas State Board of Pharmacy shall
adopt the rules required by Section 562.1085, Occupations Code, as
added by this Act, not later than December 1, 2003.
(b) Notwithstanding Section 562.1085, Occupations Code, as
added by this Act, a pharmacy is not required to accept unused drugs
from a health care facility before January 1, 2004.
SECTION 7. This Act takes effect immediately if it receives
a vote of two-thirds of all the members elected to each house, as
provided by Section 39, Article III, Texas Constitution. If this
Act does not receive the vote necessary for immediate effect, this
Act takes effect September 1, 2003.
______________________________ ______________________________
President of the Senate Speaker of the House
I certify that H.B. No. 3486 was passed by the House on May
10, 2003, by the following vote: Yeas 131, Nays 0, 1 present, not
voting; and that the House concurred in Senate amendments to H.B.
No. 3486 on May 30, 2003, by the following vote: Yeas 143, Nays 0,
2 present, not voting.
______________________________
Chief Clerk of the House
I certify that H.B. No. 3486 was passed by the Senate, with
amendments, on May 28, 2003, by the following vote: Yeas 31, Nays
0.
______________________________
Secretary of the Senate
APPROVED: __________________
Date
__________________
Governor