By Maxey H.B. No. 2838
74R5531 MLR-F
A BILL TO BE ENTITLED
1-1 AN ACT
1-2 relating to the powers and duties of the Texas Department of Health
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 431.002(23), Health and Safety Code, is
1-6 amended to read as follows:
1-7 (23) "Manufacture" means preparing, propagating,
1-8 compounding, or processing prior to distribution of a food, drug,
1-9 or device from its original place of manufacture to a wholesale
1-10 distributor of food, drugs, or devices. The term includes:
1-11 (A) repackaging or otherwise changing the
1-12 container, wrapper, or labeling of any food, drug, or device
1-13 package; and
1-14 (B) transfilling compressed and liquid forms of
1-15 medical gases <the process of combining or purifying food and
1-16 packaging food for sale to a consumer at wholesale or retail>.
1-17 SECTION 2. Sections 431.042(b) and (c), Health and Safety
1-18 Code, are amended to read as follows:
1-19 (b) The inspection of an establishment, including a factory,
1-20 warehouse, or consulting laboratory, in which a <prescription> drug
1-21 or <restricted> device is manufactured, processed, packed, or held
1-22 for introduction into commerce extends to any place or thing,
1-23 including a record, file, paper, process, control, or facility, in
1-24 order to determine whether the drug or device:
2-1 (1) is adulterated or misbranded;
2-2 (2) may not be manufactured, introduced into commerce,
2-3 sold, or offered for sale under this chapter; or
2-4 (3) is otherwise in violation of this chapter.
2-5 (c) An inspection under Subsection (b) may not extend to:
2-6 (1) financial data other than invoices, receipts,
2-7 inventory records, and other similar information relating to the
2-8 manufacture of a food, drug, or device;
2-9 (2) sales data other than shipment data;
2-10 (3) pricing data;
2-11 (4) personnel data other than data relating to the
2-12 qualifications of technical and professional personnel performing
2-13 functions under this chapter;
2-14 (5) research data other than data:
2-15 (A) relating to new drugs, antibiotic drugs, and
2-16 devices; and
2-17 (B) subject to reporting and inspection under
2-18 regulations issued under Section 505(i) or (j), 507(d) or (g), 519,
2-19 or 520(g) of the federal Act; or
2-20 (6) data relating to other drugs or devices that, in
2-21 the case of a new drug, would be subject to reporting or inspection
2-22 under regulations issued under Section 505(j) of the federal Act.
2-23 SECTION 3. Sections 431.045(a) and (c), Health and Safety
2-24 Code, are amended to read as follows:
2-25 (a) The commissioner or a person designated by the
2-26 commissioner may issue an emergency order that is restrictive,
2-27 <either> mandatory, or prohibitory in nature<,> in relation to the
3-1 manufacture, sale, or offer for sale of a food, drug, device, or
3-2 cosmetic in the department's jurisdiction if the commissioner or
3-3 the person designated by the commissioner determines that:
3-4 (1) the manufacture, sale, or offer for sale of the
3-5 food, drug, device, or cosmetic creates or poses an immediate and
3-6 serious threat to human life or health; and
3-7 (2) other procedures available to the department to
3-8 remedy or prevent the occurrence of the situation will result in
3-9 unreasonable delay.
3-10 (c) If an emergency order is issued without a hearing, the
3-11 department shall determine a time and place for a hearing at which
3-12 the emergency order is affirmed, modified, or set aside. The
3-13 hearing shall be held under the contested case provisions of
3-14 Chapter 2001, Government Code, and the board's formal hearing
3-15 <departmental> rules.
3-16 SECTION 4. Sections 431.047(a) and (b), Health and Safety
3-17 Code, are amended to read as follows:
3-18 (a) The commissioner, an authorized agent, or a health
3-19 authority may petition the district court for a temporary
3-20 restraining order to restrain a continuing violation of this
3-21 chapter or a rule or order adopted under this chapter <Subchapter
3-22 B> or a threat of a continuing violation of this chapter or a rule
3-23 or order adopted under this chapter <Subchapter B> if the
3-24 commissioner, authorized agent, or health authority finds that:
3-25 (1) a person has violated, is violating, or is
3-26 threatening to violate this chapter or a rule or order adopted
3-27 under this chapter <Subchapter B>; and
4-1 (2) the violation or threatened violation creates an
4-2 immediate threat to the health and safety of the public.
4-3 (b) A district court, on petition of the commissioner, an
4-4 authorized agent, or a health authority, and on a finding by the
4-5 court that a person is violating or threatening to violate this
4-6 chapter or a rule or order adopted under this chapter <Subchapter
4-7 B> shall grant any injunctive relief warranted by the facts.
4-8 SECTION 5. Section 431.054(a), Health and Safety Code, is
4-9 amended to read as follows:
4-10 (a) The commissioner may assess an administrative penalty
4-11 against a person who violates this chapter or a rule <Subchapter B>
4-12 or <an> order adopted or registration issued under this chapter.
4-13 SECTION 6. Sections 431.0585(a) and (c), Health and Safety
4-14 Code, are amended to read as follows:
4-15 (a) At the request of the commissioner, the attorney general
4-16 or a district, county, or city attorney shall institute an action
4-17 in district court to collect a civil penalty from a person who has
4-18 violated this chapter or a rule or order adopted under this chapter
4-19 <Section 431.021>.
4-20 (c) The court shall consider the following in determining
4-21 the amount of the penalty:
4-22 (1) the person's history of any previous violations of
4-23 this chapter or a rule or order adopted under this chapter <Section
4-24 431.021>;
4-25 (2) the seriousness of the violation;
4-26 (3) any hazard posed to the public health and safety
4-27 by the violation; and
5-1 (4) demonstrations of good faith by the person
5-2 charged.
5-3 SECTION 7. This Act takes effect September 1, 1995.
5-4 SECTION 8. The importance of this legislation and the
5-5 crowded condition of the calendars in both houses create an
5-6 emergency and an imperative public necessity that the
5-7 constitutional rule requiring bills to be read on three several
5-8 days in each house be suspended, and this rule is hereby suspended.