|
A BILL TO BE ENTITLED
|
|
AN ACT
|
|
relating to the licensing and regulation of wholesale distributors |
|
of prescription drugs; providing penalties. |
|
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
|
SECTION 1. Section 431.401, Health and Safety Code, is |
|
amended by amending Subdivisions (3), (5), and (11) and adding |
|
Subdivisions (3-a), (3-b), (4-a), (4-b), (10-a), and (12) to read |
|
as follows: |
|
(3) "Pharmacy [Chain pharmacy] warehouse" means a |
|
location for which a person holds a wholesale drug distribution |
|
license under this subchapter, that serves [primarily] as a central |
|
warehouse for drugs or devices, and from which intracompany sales |
|
or transfers of drugs or devices are made to a group of pharmacies |
|
under common ownership and control. |
|
(3-a) "Co-licensed product partner" means one of two |
|
or more parties that have the right to engage in the manufacturing |
|
or marketing of a prescription drug consistent with the United |
|
States Food and Drug Administration's regulations and guidances |
|
implementing the Prescription Drug Marketing Act of 1987 (Pub. L. |
|
No. 100-293). |
|
(3-b) "Drop shipment" means the sale of a prescription |
|
drug to a wholesale distributor by the manufacturer of the |
|
prescription drug, or by the manufacturer's co-licensed product |
|
partner, third-party logistics provider, or exclusive distributor, |
|
in which: |
|
(A) the wholesale distributor takes title but not |
|
physical possession of the prescription drug; |
|
(B) the wholesale distributor invoices the |
|
pharmacy, pharmacy warehouse, or other person authorized by law to |
|
dispense or administer the drug to a patient; and |
|
(C) the pharmacy, pharmacy warehouse, or other |
|
authorized person receives delivery of the prescription drug |
|
directly from the manufacturer or the manufacturer's third-party |
|
logistics provider or exclusive distributor. |
|
(4-a) "Manufacturer" means a person licensed or |
|
approved by the United States Food and Drug Administration to |
|
engage in the manufacture of drugs or devices, consistent with the |
|
federal agency's definition of "manufacturer" under the agency's |
|
regulations and guidances implementing the Prescription Drug |
|
Marketing Act of 1987 (Pub. L. No. 100-293). The term does not |
|
include a pharmacist engaged in compounding that is done within the |
|
practice of pharmacy and pursuant to a prescription drug order or |
|
initiative from a practitioner for a patient or prepackaging that |
|
is done in accordance with Section 562.154, Occupations Code. |
|
(4-b) "Manufacturer's exclusive distributor" means a |
|
person who holds a wholesale distributor license under this |
|
subchapter, who contracts with a manufacturer to provide or |
|
coordinate warehousing, distribution, or other services on behalf |
|
of the manufacturer, and who takes title to, but does not have |
|
general responsibility to direct the sale or disposition of, the |
|
manufacturer's prescription drug. A manufacturer's exclusive |
|
distributor must be an authorized distributor of record to be |
|
considered part of the normal distribution channel. |
|
(5) "Normal distribution channel [chain]" means a |
|
chain of custody for a prescription drug, either directly or by drop |
|
shipment, from the manufacturer of the prescription drug, the |
|
manufacturer to the manufacturer's co-licensed product partner, |
|
the manufacturer to the manufacturer's third-party logistics |
|
provider, or the manufacturer to the manufacturer's exclusive |
|
distributor, to: |
|
(A) [a manufacturer to an authorized distributor
|
|
of record or to a wholesale distributor licensed under this
|
|
subchapter to] a pharmacy [or practitioner] to: |
|
(i) a patient; or |
|
(ii) another designated person authorized |
|
by law to dispense or administer the drug to a patient; |
|
(B) an authorized distributor of record to: |
|
(i) a pharmacy to a patient; or |
|
(ii) another designated person authorized |
|
by law to dispense or administer the drug to a patient; |
|
(C) [a manufacturer to] an authorized |
|
distributor of record to a pharmacy warehouse to the pharmacy |
|
warehouse's intracompany pharmacy or another designated person |
|
authorized by law to dispense or administer the drug [one other
|
|
authorized distributor of record to a pharmacy or practitioner] to |
|
a patient; [or] |
|
(D) [(C) a manufacturer to an authorized
|
|
distributor of record to] a [chain] pharmacy warehouse to the |
|
pharmacy warehouse's intracompany pharmacy or another designated |
|
person authorized by law to dispense or administer the drug [a
|
|
pharmacy or practitioner] to a patient; or |
|
(E) a person authorized by law to prescribe a |
|
prescription drug that by law may be administered only under the |
|
supervision of the prescriber. |
|
(10-a) "Third-party logistics provider" means a |
|
person who holds a wholesale distributor license under this |
|
subchapter, who contracts with a prescription drug manufacturer to |
|
provide or coordinate warehousing, distribution, or other services |
|
on behalf of the manufacturer, and who does not take title to the |
|
prescription drug or have general responsibility to direct the |
|
prescription drug's sale or disposition. A third-party logistics |
|
provider must be an authorized distributor of record to be |
|
considered part of the normal distribution channel. |
|
(11) "Wholesale distribution" means distribution of |
|
prescription drugs to a person other than a consumer or patient[,
|
|
and includes distribution by a manufacturer, repackager, own label
|
|
distributor, broker, jobber, warehouse, retail pharmacy that
|
|
conducts wholesale distribution, or wholesaler]. The term does not |
|
include: |
|
(A) intracompany sales of prescription drugs, |
|
which means transactions or transfers of prescription drugs between |
|
a division, subsidiary, parent, or affiliated or related company |
|
that is under common ownership and control, or any transaction or |
|
transfer between co-license holders of a co-licensed product [of a
|
|
corporate entity]; |
|
(B) the sale, purchase, distribution, trade, or |
|
transfer of prescription drugs or the offer to sell, purchase, |
|
distribute, trade, or transfer a prescription drug for emergency |
|
medical reasons; |
|
(C) the distribution of prescription drug |
|
samples by a representative of a manufacturer; |
|
(D) the return of drugs by a hospital, health |
|
care entity, [retail pharmacy, chain pharmacy warehouse,] or |
|
charitable institution in accordance with 21 C.F.R. Section 203.23; |
|
[or] |
|
(E) the sale of reasonable quantities [delivery] |
|
by a retail pharmacy of a prescription drug to [a patient or a
|
|
patient's agent under the lawful order of] a licensed practitioner |
|
for office use; |
|
(F) the sale, purchase, or trade of a drug, an |
|
offer to sell, purchase, or trade a drug, or the dispensing of a |
|
drug under a prescription; |
|
(G) the sale, transfer, merger, or consolidation |
|
of all or part of the business of a pharmacy from or with another |
|
pharmacy, whether accomplished as a purchase and sale of stock or |
|
business assets; |
|
(H) the sale, purchase, distribution, trade, or |
|
transfer of a prescription drug from one authorized distributor of |
|
record to one additional authorized distributor of record if: |
|
(i) the manufacturer states in writing to |
|
the receiving distributor that the manufacturer is unable to supply |
|
the prescription drug; and |
|
(ii) the supplying distributor states in |
|
writing that the prescription drug being supplied had until that |
|
time been exclusively in the normal distribution channel; |
|
(I) the delivery of, or offer to deliver, a |
|
prescription drug by a common carrier solely in the common |
|
carrier's usual course of business of transporting prescription |
|
drugs, if the common carrier does not store, warehouse, or take |
|
legal ownership of the prescription drug; or |
|
(J) the sale or transfer from a retail pharmacy |
|
or pharmacy warehouse of expired, damaged, returned, or recalled |
|
prescription drugs to the original manufacturer or to a third-party |
|
returns processor. |
|
(12) "Wholesale distributor" means a person engaged in |
|
the wholesale distribution of prescription drugs, including a |
|
manufacturer, repackager, own-label distributor, private-label |
|
distributor, jobber, broker, manufacturer warehouse, distributor |
|
warehouse, or other warehouse, manufacturer's exclusive |
|
distributor, authorized distributor of record, drug wholesaler or |
|
distributor, independent wholesale drug trader, specialty |
|
wholesale distributor, third-party logistics provider, retail |
|
pharmacy that conducts wholesale distribution, and pharmacy |
|
warehouse that conducts wholesale distribution. |
|
SECTION 2. Section 431.4031, Health and Safety Code, is |
|
amended to read as follows: |
|
Sec. 431.4031. EXEMPTION FROM CERTAIN PROVISIONS FOR |
|
CERTAIN WHOLESALE DISTRIBUTORS. A wholesale distributor that |
|
distributes prescription drugs that are medical gases or a |
|
wholesale distributor that is a manufacturer or a third-party |
|
logistics provider on behalf of a manufacturer is exempt from |
|
Sections 431.404(a)(5) and (6), (b), [431.404(b)] and (c), |
|
431.4045, 431.405, 431.407, and 431.408[, 431.412, and 431.413]. |
|
SECTION 3. Subsections (a), (b), and (d), Section 431.404, |
|
Health and Safety Code, are amended to read as follows: |
|
(a) An applicant for a license under this subchapter must |
|
submit an application to the department on the form prescribed by |
|
the department. The application must contain: |
|
(1) the name, full business address, and telephone |
|
number of the applicant; |
|
(2) all trade or business names under which the |
|
business is conducted; |
|
(3) [(2)] the address, [and] telephone number, and |
|
name of a contact person for each of the applicant's places of |
|
business [of each place of business that is licensed]; |
|
(4) [(3)] the type of business entity and: |
|
(A) if the business is a sole proprietorship, the |
|
name of the proprietor; |
|
(B) if the business is a partnership, the name of |
|
the partnership and each of the partners; or |
|
(C) if the business is a corporation, the name of |
|
the corporation, the place of incorporation, and the name and title |
|
of each corporate officer and director [the name and residence
|
|
address of:
|
|
[(A) the proprietor, if the business is a
|
|
proprietorship;
|
|
[(B) all partners, if the business is a
|
|
partnership; or
|
|
[(C) all principals, if the business is an
|
|
association]; |
|
[(4) the date and place of incorporation, if the
|
|
business is a corporation;] |
|
(5) [the names and business addresses of the
|
|
individuals in an administrative capacity showing:
|
|
[(A) the managing proprietor, if the business is
|
|
a proprietorship;
|
|
[(B) the managing partner, if the business is a
|
|
partnership;
|
|
[(C) the officers and directors, if the business
|
|
is a corporation; or
|
|
[(D) the persons in a managerial capacity, if the
|
|
business is an association;
|
|
[(6)] the name and[,] telephone number of, and any |
|
information necessary to complete a criminal history record check |
|
on, a designated representative of each place of business; and |
|
(6) [(7) the state of incorporation, if the business
|
|
is a corporation;
|
|
[(8)] a list of all licenses and permits issued to the |
|
applicant by any other state under which the applicant is permitted |
|
to purchase or possess prescription drugs[; and
|
|
[(9) the name of the manager for each place of
|
|
business]. |
|
(b) Each person listed in Subsection (a)(5) [Subsections
|
|
(a)(6) and (a)(9)] shall provide the following to the department: |
|
(1) the person's places of residence for the past seven |
|
years; |
|
(2) the person's date and place of birth; |
|
(3) the person's occupations, positions of employment, |
|
and offices held during the past seven years; |
|
(4) the business name and address of any business, |
|
corporation, or other organization in which the person held an |
|
office under Subdivision (3) or in which the person conducted an |
|
occupation or held a position of employment; |
|
(5) a statement of whether during the preceding seven |
|
years the person was the subject of a proceeding to revoke a license |
|
or a criminal proceeding and the nature and disposition of the |
|
proceeding; |
|
(6) a statement of whether during the preceding seven |
|
years the person has been enjoined, either temporarily or |
|
permanently, by a court from violating any federal or state law |
|
regulating the possession, control, or distribution of |
|
prescription drugs, including the details concerning the event; |
|
(7) a written description of any involvement by the |
|
person as an officer or director with any business, including any |
|
investments, other than the ownership of stock in a publicly traded |
|
company or mutual fund during the past seven years, that |
|
manufactured, administered, prescribed, distributed, or stored |
|
pharmaceutical products and any lawsuits in which the businesses |
|
were named as a party; |
|
(8) a description of any misdemeanor or felony offense |
|
for which the person, as an adult, was found guilty, regardless of |
|
whether adjudication of guilt was withheld or whether the person |
|
pled guilty or nolo contendere; |
|
(9) a description of any criminal conviction of the |
|
person under appeal, a copy of the notice of appeal for that |
|
criminal offense, and a copy of the final written order of an appeal |
|
not later than the 15th day after the date of the appeal's |
|
disposition; and |
|
(10) a photograph of the person taken not earlier than |
|
180 [30] days before the date the application was submitted. |
|
(d) An applicant or license holder shall submit to [file
|
|
with] the department [a written notice of] any change in or |
|
correction to the information required under this section in the |
|
form and manner prescribed by the department. |
|
SECTION 4. Subchapter N, Chapter 431, Health and Safety |
|
Code, is amended by adding Section 431.4045 to read as follows: |
|
Sec. 431.4045. INSPECTION REQUIRED. The department may not |
|
issue a wholesale distributor license to an applicant under this |
|
subchapter unless the department: |
|
(1) conducts a physical inspection of the place of |
|
business at the address provided by the applicant under Section |
|
431.404; and |
|
(2) determines that the designated representative of |
|
the place of business meets the qualifications required by Section |
|
431.405. |
|
SECTION 5. Section 431.405, Health and Safety Code, is |
|
amended to read as follows: |
|
Sec. 431.405. QUALIFICATIONS FOR LICENSE. To qualify for |
|
the issuance or renewal of a wholesale distributor license under |
|
this subchapter, the designated representative of an applicant or |
|
license holder must: |
|
(1) be at least 21 years of age; |
|
(2) have been employed full-time for at least three |
|
years by a pharmacy or a wholesale distributor in a capacity related |
|
to the dispensing or distributing of prescription drugs, including |
|
recordkeeping for the dispensing or distributing of prescription |
|
drugs; |
|
(3) be employed by the applicant full-time in a |
|
managerial-level position; |
|
(4) be actively involved in and aware of the actual |
|
daily operation of the wholesale distributor; |
|
(5) be physically present at the applicant's place of |
|
business during regular business hours, except when the absence of |
|
the designated representative is authorized, including sick leave |
|
and vacation leave; |
|
(6) serve as a designated representative for only one |
|
applicant at any one time, except in a circumstance in which more |
|
than one licensed wholesale distributor is colocated in the same |
|
place of business and the wholesale distributors are members of an |
|
affiliated group, as defined by Section 1504, Internal Revenue Code |
|
of 1986; |
|
(7) not have been convicted of a violation of any |
|
federal, state, or local laws relating to wholesale or retail |
|
prescription drug distribution or the distribution of controlled |
|
substances; and |
|
(8) not have been convicted of a felony under a |
|
federal, state, or local law. |
|
SECTION 6. Section 431.408, Health and Safety Code, is |
|
amended by adding Subsections (a-1) and (c-1) to read as follows: |
|
(a-1) A pharmacy warehouse that is not engaged in wholesale |
|
distribution is exempt from the bond requirement under Subsection |
|
(a). |
|
(c-1) A single bond is sufficient to cover all places of |
|
business operated by a wholesale distributor in this state. |
|
SECTION 7. Subchapter N, Chapter 431, Health and Safety |
|
Code, is amended by adding Section 431.4095 to read as follows: |
|
Sec. 431.4095. RENEWAL NOTIFICATION; CHANGE OR RENEWAL. |
|
(a) Before the expiration of a license issued under this |
|
subchapter, the department shall send to each licensed wholesale |
|
distributor a form containing a copy of the information the |
|
distributor provided to the department under Section 431.404. |
|
(b) Not later than the 30th day after the date the wholesale |
|
distributor receives the form under Subsection (a), the wholesale |
|
distributor shall identify and state under oath to the department |
|
any change in or correction to the information. |
|
SECTION 8. Subchapter N, Chapter 431, Health and Safety |
|
Code, is amended by adding Sections 431.4101 and 431.4102 to read as |
|
follows: |
|
Sec. 431.4101. CONTINUING TRAINING. Designated |
|
representatives identified in Section 431.404(a)(5) shall |
|
successfully complete continuing training regarding applicable |
|
federal and state laws governing the wholesale distribution of |
|
prescription drugs as required by department rule. |
|
Sec. 431.4102. CONFIDENTIALITY. Information provided |
|
under Section 431.404 may not be disclosed to any person other than |
|
the department for licensing or monitoring purposes. |
|
SECTION 9. Section 431.411, Health and Safety Code, is |
|
amended by amending Subsection (a) and adding Subsections (a-1), |
|
(a-2), and (e) to read as follows: |
|
(a) A wholesale distributor shall receive prescription drug |
|
returns or exchanges from a pharmacy or [chain] pharmacy warehouse |
|
in accordance with the terms and conditions of the agreement |
|
between the wholesale distributor and the pharmacy or [chain] |
|
pharmacy warehouse. An expired, damaged, recalled, or otherwise |
|
nonsalable prescription drug that is returned to the wholesale |
|
distributor may be distributed by the wholesale distributor only to |
|
either the original manufacturer or a third-party returns |
|
processor. The returns or exchanges, salable or otherwise, |
|
received by the wholesale distributor as provided by this |
|
subsection, including any redistribution of returns or exchanges by |
|
the wholesale distributor, are not subject to the pedigree |
|
requirement under Section 431.412 if the returns or exchanges are |
|
exempt from pedigree under: |
|
(1) Section 503, Prescription Drug Marketing Act of |
|
1987 (21 U.S.C. Section 353(c)(3)(B)); |
|
(2) the regulations adopted by the secretary to |
|
administer and enforce that Act; or |
|
(3) the interpretations of that Act set out in the |
|
compliance policy guide of the United States Food and Drug |
|
Administration. |
|
(a-1) Each [In connection with the returned goods process,
|
|
a] wholesale distributor and pharmacy shall administer the process |
|
of drug returns and exchanges to ensure that the process is secure |
|
and does not permit [should establish appropriate business
|
|
practices and exercise due diligence designed to prevent] the entry |
|
of adulterated or counterfeit drugs into the distribution channel. |
|
(a-2) Notwithstanding any provision of state or federal law |
|
to the contrary, a person that has not otherwise been required to |
|
obtain a wholesale license under this subchapter and that is a |
|
pharmacy engaging in the sale or transfer of expired, damaged, |
|
returned, or recalled prescription drugs to the originating |
|
wholesale distributor or manufacturer and pursuant to federal |
|
statute, rules, and regulations, including the United States Food |
|
and Drug Administration's applicable guidances implementing the |
|
Prescription Drug Marketing Act of 1987 (Pub. L. No. 100-293), is |
|
exempt from wholesale licensure requirements under this |
|
subchapter. |
|
(e) A manufacturer or wholesale distributor may not accept |
|
payment for, or allow the use of a person's credit to establish an |
|
account for the purchase of, prescription drugs from any person |
|
other than the owner of record, the chief executive officer, or the |
|
chief financial officer listed on the license of a person legally |
|
authorized to receive prescription drugs. Any account for the |
|
purchase of prescription drugs must be established in the name of |
|
the license holder or the license holder's professional entity, as |
|
that term is defined by Section 301.003, Business Organizations |
|
Code. This subsection does not prohibit a pharmacy or pharmacy |
|
warehouse from receiving prescription drugs where the payment for |
|
the prescription drugs is processed through the pharmacy's or |
|
pharmacy warehouse's contractual wholesale distributor. |
|
SECTION 10. Section 431.412, Health and Safety Code, is |
|
amended by amending Subsections (a) and (d) and adding Subsection |
|
(b-1) to read as follows: |
|
(a) A person who is engaged in the wholesale distribution of |
|
a prescription drug, including a repackager but excluding the |
|
original manufacturer [and the original labeler of a prescription
|
|
drug], shall provide a pedigree for each prescription drug that |
|
leaves or at any time has left [is not distributed through] the |
|
normal distribution channel [chain] and is sold, traded, or |
|
transferred to any other person. |
|
(b-1) A retail pharmacy or pharmacy warehouse is required to |
|
comply with this section only if the pharmacy or warehouse engages |
|
in the wholesale distribution of a prescription drug. |
|
(d) A person who is engaged in the wholesale distribution of |
|
a prescription drug, including a repackager, but excluding the |
|
original manufacturer of the finished form of a prescription drug, |
|
and who is in possession of a pedigree for a prescription drug must |
|
verify before distributing the prescription drug that each |
|
transaction listed on the pedigree has occurred. |
|
SECTION 11. Section 431.413, Health and Safety Code, is |
|
amended by amending Subsections (a), (c), and (e) and adding |
|
Subsection (e-1) to read as follows: |
|
(a) A pedigree must include all necessary identifying |
|
information concerning each sale in the product's chain of |
|
distribution from the manufacturer, or from the manufacturer's |
|
third-party logistics provider, co-licensed product partner, or |
|
exclusive distributor, through acquisition and sale by a wholesale |
|
distributor or repackager, until final sale to a pharmacy or other |
|
person dispensing or administering the drug. At a minimum, the |
|
chain of distribution information must include: |
|
(1) the name, address, telephone number, and, if |
|
available, the e-mail address of each person who owns [or
|
|
possesses] the prescription drug and each wholesale distributor of |
|
the prescription drug[, except common carriers and logistics
|
|
providers]; |
|
(2) [the signature of each owner of the prescription
|
|
drug;
|
|
[(3)] the name and address of each location from which |
|
the product was shipped, if different from the owner's name and |
|
address; |
|
(3) [(4)] the transaction dates; and |
|
(4) [(5)] certification that each recipient has |
|
authenticated the pedigree. |
|
(c) Each pedigree statement must be: |
|
(1) maintained by the purchaser and the wholesale |
|
distributor for at least three years; and |
|
(2) available for inspection and photocopying not |
|
later than the fifth business day after the date [on] a request is |
|
submitted by the department or a peace officer in this state. |
|
(e) The department shall: |
|
(1) conduct a study on the implementation of |
|
electronic pedigrees; and |
|
(2) in conducting the study under Subdivision (1), |
|
consult with manufacturers, distributors, and pharmacies |
|
responsible for the sale and distribution of prescription drugs in |
|
this state[; and
|
|
[(3) based on the results of the study, establish an
|
|
implementation date, which may not be earlier than December 31,
|
|
2007, for electronic pedigrees]. |
|
(e-1) If, after consulting with manufacturers, |
|
distributors, and pharmacies responsible for the sale and |
|
distribution of prescription drugs in this state, the department |
|
determines that electronic track and trace pedigree technology is |
|
universally available across the entire prescription |
|
pharmaceutical supply chain, the department shall establish a |
|
targeted implementation date for electronic track and trace |
|
pedigree technology. After the department has established a |
|
targeted implementation date, the department may revise the date. |
|
The targeted implementation date may not be earlier than July 1, |
|
2010. |
|
SECTION 12. Section 431.414, Health and Safety Code, is |
|
amended by adding Subsection (a-1) to read as follows: |
|
(a-1) The commissioner of state health services may suspend |
|
or revoke a license if the license holder no longer meets the |
|
qualifications for obtaining a license under Section 431.405. |
|
SECTION 13. Section 431.415, Health and Safety Code, is |
|
amended by amending Subsection (a) and adding Subsection (a-1) to |
|
read as follows: |
|
(a) Except as provided by Subsection (a-1), the [The] |
|
commissioner of state health services shall issue an order |
|
requiring a person, including a [manufacturer,] distributor[,] or |
|
retailer of a prescription drug, to immediately cease distribution |
|
of the drug if the commissioner determines there is a reasonable |
|
probability that: |
|
(1) a wholesale distributor has: |
|
(A) violated this subchapter; |
|
(B) falsified a pedigree; or |
|
(C) sold, distributed, transferred, |
|
manufactured, repackaged, handled, or held a counterfeit |
|
prescription drug intended for human use that could cause serious |
|
adverse health consequences or death; and |
|
(2) other procedures would result in unreasonable |
|
delay. |
|
(a-1) This section does not authorize the commissioner of |
|
state health services to issue a cease and desist order against a |
|
manufacturer. |
|
SECTION 14. Subchapter N, Chapter 431, Health and Safety |
|
Code, is amended by adding Sections 431.416 and 431.417 to read as |
|
follows: |
|
Sec. 431.416. PROHIBITED ACTS. (a) The following acts and |
|
the causing of or aiding or abetting of the following acts within |
|
this state are unlawful and prohibited: |
|
(1) the failure to obtain a license in accordance with |
|
this subchapter; |
|
(2) operating without a valid license when a license |
|
is required by this subchapter; |
|
(3) the purchase or receipt of a prescription drug |
|
from a pharmacy in violation of Section 431.411(a) or (a-1); |
|
(4) if a license is required under Section 431.411(b), |
|
the sale, distribution, or transfer of a prescription drug to a |
|
person who is not authorized under the laws of the jurisdiction in |
|
which the person receives the prescription drug to receive the |
|
prescription drug; |
|
(5) the failure to deliver a prescription drug to a |
|
specified premise, as required by Section 431.411(c); |
|
(6) accepting payment or credit for the sale of a |
|
prescription drug in violation of Section 431.411(e); |
|
(7) the failure to maintain or provide a pedigree as |
|
required by this subchapter; |
|
(8) the failure to obtain, pass, or authenticate a |
|
pedigree as required by this subchapter; |
|
(9) providing this state or a representative of this |
|
state or a federal official with a false or fraudulent record |
|
regarding any matter covered under this subchapter; |
|
(10) making a false or fraudulent statement regarding |
|
any matter covered under this subchapter; |
|
(11) obtaining or attempting to obtain a prescription |
|
drug by fraud, deceit, or misrepresentation; |
|
(12) engaging in misrepresentation or fraud in the |
|
distribution of a prescription drug; |
|
(13) except for a manufacturer's wholesale |
|
distribution of a prescription drug that has been delivered into |
|
commerce pursuant to an application approved under federal law by |
|
the United States Food and Drug Administration, the manufacture, |
|
repacking, sale, transfer, delivery, or holding of, or offering for |
|
sale, any prescription drug that is adulterated, misbranded, |
|
counterfeit, or suspected of being counterfeit or has otherwise |
|
been rendered unfit for distribution; |
|
(14) except for a manufacturer's wholesale |
|
distribution of a prescription drug that has been delivered into |
|
commerce pursuant to an application approved under federal law by |
|
the United States Food and Drug Administration, the adulteration, |
|
misbranding, or counterfeiting of any prescription drug; |
|
(15) the receipt of a prescription drug that is |
|
adulterated, misbranded, stolen, obtained by fraud or deceit, |
|
counterfeit, or suspected of being counterfeit, and the delivery or |
|
proffered delivery of such a drug for payment or otherwise; and |
|
(16) the alteration, mutilation, destruction, |
|
obliteration, or removal of all or any part of the labeling of a |
|
prescription drug or the commission of any other act with respect to |
|
a prescription drug that results in the prescription drug being |
|
misbranded. |
|
(b) Subsection (a) does not apply to a prescription drug |
|
manufacturer, or an agent of a prescription drug manufacturer, who |
|
is obtaining or attempting to obtain a prescription drug for the |
|
sole purpose of testing the prescription drug for authenticity. |
|
Sec. 431.417. CRIMINAL PENALTIES. (a) A person commits an |
|
offense if the person knowingly or with criminal negligence engages |
|
in the wholesale distribution of prescription drugs in violation of |
|
this subchapter. |
|
(b) Except as otherwise provided by this section, an offense |
|
under this section is a felony punishable by imprisonment for a term |
|
not to exceed 15 years, a fine not to exceed $50,000, or both |
|
imprisonment and a fine. |
|
(c) If it is shown on the trial of an offense under this |
|
section that the person knowingly engaged in the wholesale |
|
distribution of prescription drugs in violation of this subchapter, |
|
the offense is a felony punishable by imprisonment for a term of not |
|
more than 99 years or less than 15 years, a fine not to exceed |
|
$500,000, or both imprisonment and a fine. |
|
(d) If conduct constituting an offense under this section |
|
also constitutes an offense under any other law, the actor may be |
|
prosecuted under this section, the other law, or both. |
|
SECTION 15. Subsections (a-1) and (a-2), Section 431.059, |
|
and Subsections (b) and (c), Section 431.412, Health and Safety |
|
Code, are repealed. |
|
SECTION 16. The executive commissioner of the Health and |
|
Human Services Commission shall adopt the rules necessary to |
|
implement the changes in law made by this Act not later than |
|
December 1, 2007. |
|
SECTION 17. The change in law made by this Act applies only |
|
to an offense committed on or after the effective date of this Act. |
|
An offense committed before the effective date of this Act is |
|
covered by the law in effect when the offense was committed, and the |
|
former law is continued in effect for that purpose. For purposes of |
|
this section, an offense was committed before the effective date of |
|
this Act if any element of the offense was committed before that |
|
date. |
|
SECTION 18. This Act takes effect September 1, 2007. |