By Maxey                                              H.B. No. 2838
          Substitute the following for H.B. No. 2838:
          By Berlanga                                       C.S.H.B. No. 2838
                                 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:
    1-8                    (A)  the process of combining or purifying food
    1-9  and packaging food for sale or to a consumer at wholesale or retail
   1-10  and includes repackaging or otherwise changing the container,
   1-11  wrapper, or labeling of any food;
   1-12                    (B)  the process of preparing, propagating,
   1-13  compounding, processing, packaging, holding, repackaging, labeling,
   1-14  testing and quality control of drugs and drug products;
   1-15                    (C)  the process of preparing, fabricating,
   1-16  assembling, processing, packing, repacking, labeling or relabeling
   1-17  a device;
   1-18                    (D)  the making of any cosmetic product by
   1-19  chemical, physical, biological, or other procedures, including
   1-20  manipulation, sampling, testing, or control procedures applied to
   1-21  the product <the process of combining or purifying food and
   1-22  packaging food for sale to a consumer at wholesale or retail>.
   1-23        SECTION 2.  Section 431.021(h), Health and Safety Code is
   1-24  amended to read as follows:
    2-1        (h)  the manufacture or sale within this state of any food,
    2-2  drug, device, or cosmetic that is adulterated or misbranded;
    2-3        SECTION 3.  Section 431.042(b), Health and Safety Code is
    2-4  amended to read as follows:
    2-5        (b)  The inspection of an establishment, including a factory,
    2-6  warehouse, or consulting laboratory, in which a <prescription>
    2-7  drug, <or restricted> device, or cosmetic is manufactured,
    2-8  processed, packed, or held for introduction into commerce extends
    2-9  to any place or thing, including a record, file, paper, process,
   2-10  control, or facility, in order to determine whether the drug, <or>
   2-11  device, or cosmetic:
   2-12              (1)  is adulterated or misbranded;
   2-13              (2)  may not be manufactured, introduced into commerce,
   2-14  sold or offered for sale under this chapter; or
   2-15              (3)  is otherwise in violation of this chapter.
   2-16        SECTION 4.  Sections 431.045(a) and (c), Health and Safety
   2-17  Code, are amended to read as follows:
   2-18        (a)  The commissioner or a person designated by the
   2-19  commissioner may issue an emergency order that is restrictive,
   2-20  <either> mandatory, or prohibitory in nature<,> in relation to the
   2-21  manufacture or sale of a food, drug, device, or cosmetic in the
   2-22  department's jurisdiction if the commissioner or the person
   2-23  designated by the commissioner determines that:
   2-24              (1)  the manufacture or sale of the food, drug, device,
   2-25  or cosmetic creates or poses an immediate and serious threat to
   2-26  human life or health; and
   2-27              (2)  other procedures available to the department to
    3-1  remedy or prevent the occurrence of the situation will result in
    3-2  unreasonable delay.
    3-3        (c)  If an emergency order is issued without a hearing, the
    3-4  department shall determine a time and place for a hearing at which
    3-5  the emergency order is affirmed, modified, or set aside.  The
    3-6  hearing shall be held under the contested case provisions of
    3-7  Chapter 2001, Government Code, and the board's formal hearing
    3-8  <departmental> rules.
    3-9        SECTION 5.  Section 431.221(4), Health and Safety Code, is
   3-10  amended to read as follows:
   3-11              (4)  "Manufacture" means the process of combining or
   3-12  purifying food and packaging food for sale to a consumer at
   3-13  wholesale or retail and includes repackaging or otherwise changing
   3-14  the container, wrapper, or labeling of any food.
   3-15        SECTION 6.  This Act takes effect September 1, 1995.
   3-16        SECTION 7.  The importance of this legislation and the
   3-17  crowded condition of the calendars in both houses create an
   3-18  emergency and an imperative public necessity that the
   3-19  constitutional rule requiring bills to be read on three several
   3-20  days in each house be suspended, and this rule is hereby suspended,
   3-21  and that this Act take effect and be in force from and after its
   3-22  passage, and it is so enacted.