By Van de Putte                                 H.B. No. 1075

      75R3605 SKB-D                           

                                A BILL TO BE ENTITLED

 1-1                                   AN ACT

 1-2     relating to prohibited acts, inspections, and emergency orders

 1-3     under the Texas Food, Drug, and Cosmetic Act.

 1-4           BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:

 1-5           SECTION 1.  Section 431.021, Health and Safety Code, is

 1-6     amended to read as follows:

 1-7           Sec. 431.021.  PROHIBITED ACTS.  The following acts and the

 1-8     causing of the following acts within this state are unlawful and

 1-9     prohibited:

1-10                 (a)  the introduction or delivery for introduction into

1-11     commerce of any food, drug, device, or cosmetic that is adulterated

1-12     or misbranded;

1-13                 (b)  the adulteration or misbranding of any food, drug,

1-14     device, or cosmetic in commerce;

1-15                 (c)  the receipt in commerce of any food, drug, device,

1-16     or cosmetic that is adulterated or misbranded, and the delivery or

1-17     proffered delivery thereof for pay or otherwise;

1-18                 (d)  the distribution in commerce of a consumer

1-19     commodity, if such commodity is contained in a package, or if there

1-20     is affixed to that commodity a label that does not conform to the

1-21     provisions of this chapter and of rules adopted under the authority

1-22     of this chapter;  provided, however, that this prohibition shall

1-23     not apply to persons engaged in business as wholesale or retail

1-24     distributors of consumer commodities except to the extent that such

 2-1     persons:

 2-2                       (1)  are engaged in the packaging or labeling of

 2-3     such commodities; or

 2-4                       (2)  prescribe or specify by any means the manner

 2-5     in which such commodities are packaged or labeled;

 2-6                 (e)  the introduction or delivery for introduction into

 2-7     commerce of any article in violation of Section 431.084, 431.114,

 2-8     or 431.115;

 2-9                 (f)  the dissemination of any false advertisement;

2-10                 (g)  the refusal to permit entry or inspection, or to

2-11     permit the taking of a sample or to permit access to or copying of

2-12     any record as authorized by Sections 431.042-431.044;  or the

2-13     failure to establish or maintain any record or make any report

2-14     required under Section 512(j), (l), or (m) of the federal Act, or

2-15     the refusal to permit access to or verification or copying of any

2-16     such required record;

2-17                 (h)  the sale [manufacture] within this state of any

2-18     food, drug, device, or cosmetic that is adulterated or misbranded;

2-19                 (i)  the giving of a guaranty or undertaking referred

2-20     to in Section 431.059, which guaranty or undertaking is false,

2-21     except by a person who relied on a guaranty or undertaking to the

2-22     same effect signed by, and containing the name and address of the

2-23     person residing in this state from whom the person received in good

2-24     faith the food, drug, device, or cosmetic;  or the giving of a

2-25     guaranty or undertaking referred to in Section 431.059, which

2-26     guaranty or undertaking is false;

2-27                 (j)  the removal or disposal of a detained or embargoed

 3-1     article in violation of Section 431.048;

 3-2                 (k)  the alteration, mutilation, destruction,

 3-3     obliteration, or removal of the whole or any part of the labeling

 3-4     of, or the doing of any other act with respect to a food, drug,

 3-5     device, or cosmetic, if such act is done while such article is held

 3-6     for sale after shipment in commerce and results in such article

 3-7     being adulterated or misbranded;

 3-8                 (l)(1)  forging, counterfeiting, simulating, or falsely

 3-9     representing, or without proper authority using any mark, stamp,

3-10     tag, label, or other identification device authorized or required

3-11     by rules adopted under this chapter or the regulations promulgated

3-12     under the provisions of the federal Act;

3-13                       (2)  making, selling, disposing of, or keeping in

3-14     possession, control, or custody, or concealing any punch, die,

3-15     plate, stone, or other thing designed to print, imprint, or

3-16     reproduce the trademark, trade name, or other identifying mark,

3-17     imprint, or device of another or any likeness of any of the

3-18     foregoing on any drug or container or labeling thereof so as to

3-19     render such drug a counterfeit drug;

3-20                       (3)  the doing of any act that causes a drug to

3-21     be a counterfeit drug, or the sale or dispensing, or the holding

3-22     for sale or dispensing, of a counterfeit drug;

3-23                 (m)  the using by any person to the person's own

3-24     advantage, or revealing, other than to the commissioner, an

3-25     authorized agent, a health authority or to the courts when relevant

3-26     in any judicial proceeding under this chapter, of any information

3-27     acquired under the authority of this chapter concerning any method

 4-1     or process that as a trade secret is entitled to protection;

 4-2                 (n)  the using, on the labeling of any drug or device

 4-3     or in any advertising relating to such drug or device, of any

 4-4     representation or suggestion that approval of an application with

 4-5     respect to such drug or device is in effect under Section 431.114

 4-6     or Section 505, 515, or 520(g) of the federal Act, as the case may

 4-7     be, or that such drug or device complies with the provisions of

 4-8     such sections;

 4-9                 (o)  the using, in labeling, advertising or other sales

4-10     promotion of any reference to any report or analysis furnished in

4-11     compliance with Sections 431.042-431.044 or Section 704 of the

4-12     federal Act;

4-13                 (p)  in the case of a [prescription] drug distributed

4-14     or offered for sale in this state, the failure of the manufacturer,

4-15     packer, or distributor of the drug to maintain for transmittal, or

4-16     to transmit, to any practitioner licensed by applicable law to

4-17     administer such drug who makes written request for information as

4-18     to such drug, true and correct copies of all printed matter that is

4-19     required to be included in any package in which that drug is

4-20     distributed or sold, or such other printed matter as is approved

4-21     under the federal Act.  Nothing in this subsection shall be

4-22     construed to exempt any person from any labeling requirement

4-23     imposed by or under other provisions of this chapter;

4-24                 (q)(1)  placing or causing to be placed on any drug or

4-25     device or container of any drug or device, with intent to defraud,

4-26     the trade name or other identifying mark, or imprint of another or

4-27     any likeness of any of the foregoing;

 5-1                       (2)  selling, dispensing, disposing of or causing

 5-2     to be sold, dispensed, or disposed of, or concealing or keeping in

 5-3     possession, control, or custody, with intent to sell, dispense, or

 5-4     dispose of, any drug, device, or any container of any drug or

 5-5     device, with knowledge that the trade name or other identifying

 5-6     mark or imprint of another or any likeness of any of the foregoing

 5-7     has been placed thereon in a manner prohibited by Subdivision (1)

 5-8     of this subsection; or

 5-9                       (3)  making, selling, disposing of, causing to be

5-10     made, sold, or disposed of, keeping in possession, control, or

5-11     custody, or concealing with intent to defraud any punch, die,

5-12     plate, stone, or other thing designed to print, imprint, or

5-13     reproduce the trademark, trade name, or other identifying mark,

5-14     imprint, or device of another or any likeness of any of the

5-15     foregoing on any drug or container or labeling of any drug or

5-16     container so as to render such drug a counterfeit drug;

5-17                 (r)  dispensing or causing to be dispensed a different

5-18     drug in place of the drug ordered or prescribed without the express

5-19     permission in each case of the person ordering or prescribing;

5-20                 (s)  the failure to register in accordance with Section

5-21     510 of the federal Act, the failure to provide any information

5-22     required by Section 510(j) or (k) of the federal Act, or the

5-23     failure to provide a notice required by Section 510(j)(2) of the

5-24     federal Act;

5-25                 (t)(1)  the failure or refusal to:

5-26                             (A)  comply with any requirement prescribed

5-27     under Section 518 or 520(g) of the federal Act; or

 6-1                             (B)  furnish any notification or other

 6-2     material or information required by or under Section 519 or 520(g)

 6-3     of the federal Act;

 6-4                       (2)  with respect to any device, the submission

 6-5     of any report that is required by or under this chapter that is

 6-6     false or misleading in any material respect;

 6-7                 (u)  the movement of a device in violation of an order

 6-8     under Section 304(g) of the federal Act or the removal or

 6-9     alteration of any mark or label required by the order to identify

6-10     the device as detained;

6-11                 (v)  the failure to provide the notice required by

6-12     Section 412(b) or 412(c), the failure to make the reports required

6-13     by Section 412(d)(1)(B), or the failure to meet the requirements

6-14     prescribed under Section 412(d)(2) of the federal Act;

6-15                 (w)  the acceptance by a person of an unused

6-16     prescription or drug, in whole or in part, for the purpose of

6-17     resale, after the prescription or drug has been originally

6-18     dispensed, or sold;

6-19                 (x)  engaging in the wholesale distribution of drugs or

6-20     operating as a distributor or manufacturer of devices in this state

6-21     without filing a licensing statement with the commissioner as

6-22     required by Section 431.202 or having a license as required by

6-23     Section 431.272, as applicable;

6-24                 (y)  engaging in the manufacture of food in this state

6-25     without first registering with the department as required by

6-26     Section 431.222; or

6-27                 (z)  unless approved by the United States Food and Drug

 7-1     Administration pursuant to the federal Act, the sale, delivery,

 7-2     holding, or offering for sale of a self-testing kit designed to

 7-3     indicate whether a person has a human immunodeficiency virus

 7-4     infection, acquired immune deficiency syndrome, or a related

 7-5     disorder or condition.

 7-6           SECTION 2.  Sections 431.042(b) and (c), Health and Safety

 7-7     Code, are amended to read as follows:

 7-8           (b)  The inspection of an establishment, including a factory,

 7-9     warehouse, or consulting laboratory, in which a [prescription]

7-10     drug, [or restricted] device, or cosmetic is manufactured,

7-11     processed, packed, or held for introduction into commerce extends

7-12     to any place or thing, including a record, file, paper, process,

7-13     control, or facility, in order to determine whether the drug, [or]

7-14     device, or cosmetic:

7-15                 (1)  is adulterated or misbranded;

7-16                 (2)  may not be manufactured, introduced into commerce,

7-17     sold, or offered for sale under this chapter; or

7-18                 (3)  is otherwise in violation of this chapter.

7-19           (c)  An inspection under Subsection (b) may not extend to:

7-20                 (1)  financial data that is not related to the

7-21     investigation  of the sale of a drug in violation of a purchasing

7-22     agreement;

7-23                 (2)  sales data other than shipment data;

7-24                 (3)  pricing data;

7-25                 (4)  personnel data other than data relating to the

7-26     qualifications of technical and professional personnel performing

7-27     functions under this chapter;

 8-1                 (5)  research data other than data:

 8-2                       (A)  relating to new drugs, antibiotic drugs, and

 8-3     devices;  and

 8-4                       (B)  subject to reporting and inspection under

 8-5     regulations issued under Section 505(i) or (j), 507(d) or (g), 519,

 8-6     or 520(g) of the federal Act;  or

 8-7                 (6)  data relating to other drugs or devices that, in

 8-8     the case of a new drug, would be subject to reporting or inspection

 8-9     under regulations issued under Section 505(j) of the federal Act.

8-10            SECTION 3.  Section 431.045(a), Health and Safety Code, is

8-11     amended to read as follows:

8-12           (a)  The commissioner or a person designated by the

8-13     commissioner may issue an emergency order, either mandatory or

8-14     prohibitory in nature, in relation to the sale [manufacture] of a

8-15     food, drug, device, or cosmetic in the department's jurisdiction if

8-16     the commissioner or the person designated by the commissioner

8-17     determines that:

8-18                 (1)  the sale [manufacture] of the food, drug, device,

8-19     or cosmetic creates or poses an immediate and serious threat to

8-20     human life or health; and

8-21                 (2)  other procedures available to the department to

8-22     remedy or prevent the occurrence of the situation will result in

8-23     unreasonable delay.

8-24           SECTION 4.  This Act takes effect September 1, 1997.

8-25           SECTION 5.  The importance of this legislation and the

8-26     crowded condition of the calendars in both houses create an

8-27     emergency and an imperative public necessity that the

 9-1     constitutional rule requiring bills to be read on three several

 9-2     days in each house be suspended, and this rule is hereby suspended.