1. (a) Licensing requirements.

   1. (1) It is unlawful for a person to provide radioactive drug services unless such provision is performed by a person licensed to act as an authorized nuclear pharmacist, as defined by the board, or is a person acting under the direct supervision of an authorized nuclear pharmacist acting in accordance with the Act and its rules, and the regulations of the Texas Department of Health, Bureau of Radiation Control. Subsection (a) of this section does not apply to:

      1. (A) a licensed practitioner or his or her designated agent for administration to his or her patient, provided no person may receive, possess, use, transfer, own, acquire, or dispose of radiopharmaceuticals except as authorized in a specific or a general license as provided in Texas Regulations for Control of Radiation, Part 41, Texas Department of Health, or the Act;
      2. (B) institutions and/or facilities with nuclear medicine services operated by practitioners and who are licensed by the Texas Department of Health, Bureau of Radiation Control, to prescribe, administer, and dispense radioactive materials (drugs and/or devices).
   2. (2) An applicant for a Class B pharmacy shall provide evidence to the board of the possession of a Texas Department of Health Radiation Control Number.
   3. (3) A Class B pharmacy shall register annually with the board on a pharmacy license application provided by the board, following the procedures specified in §291.1 of this title (relating to Pharmacy License Application).
   4. (4) A Class B pharmacy which changes ownership shall notify the board within ten days of the change of ownership and apply for a new and separate license as specified in §291.4 of this title (relating to Change of Ownership).
   5. (5) A Class B pharmacy which changes location and/or name shall notify the board within ten days of the change and file for an amended license as specified in §291.2 of this title (relating to Change of Location and/or Name).
   6. (6) A Class B pharmacy owned by a partnership or corporation which changes managing officers shall notify the board in writing of the names of the new managing officers within ten days of the change, following the procedures in §291.3 of this title (relating to Change of Managing Officers).
   7. (7) A Class B pharmacy shall notify the board in writing within ten days of closing, following the procedures in §291.5 of this title (relating to Closed Pharmacies).
   8. (8) A separate license is required for each principal place of business and only one pharmacy license may be issued to a specific location.
   9. (9) A fee as specified in §291.6 of this title (relating to Pharmacy License Fees) will be charged for the issuance and renewal of a license and the issuance of an amended license.
   10. (10) A Class B pharmacy, licensed under the provisions of the Act, §560.051(a)(2), which also operates another type of pharmacy which would otherwise be required to be licensed under the Act, §560.051(a)(1), concerning community pharmacy (Class A), is not required to secure a license for such other type of pharmacy; provided, however, such licensee is required to comply with the provisions of §291.31 of this title (relating to Definitions); §291.32 of this title (relating to Personnel); §291.33 of this title (relating to Operational Standards); §291.34 of this title (relating to Records); and §291.35 of this title (relating to Official Prescription Requirements), to the extent such rules are applicable to the operation of the pharmacy.
   11. (11) A Class B pharmacy engaged in nonsterile compounding of drug products shall comply with the provisions of §291.25 of this title (relating to Pharmacies Compounding Non-Sterile Pharmaceuticals)
   12. (12) A Class B pharmacy engaged in sterile compounding of pharmaceutical drug products other than radiopharmaceuticals shall comply with the provisions of §291.26 of this title (relating to Pharmacies Compounding Sterile Pharmaceuticals).

2. (b) Risk levels for compounded sterile pharmaceuticals. Risk Levels for sterile compounded preparations shall be as outlined in USP/NF Chapter 797 Pharmacy Compounding Sterile Preparations and as listed below.

   1. (1) Low-risk level compounded sterile pharmaceuticals.

      1. (A) Low-risk level compounded sterile pharmaceuticals are those compounded under all of the following conditions.

         1. (i) The compounded sterile preparations are compounded with aseptic manipulations entirely within ISO Class 5 or better air quality using only sterile ingredients, products, components, and devices.
         2. (ii) The compounding involves only transfer, measuring, and mixing manipulations with closed or sealed packaging systems that are performed promptly and attentively.
         3. (iii) Manipulations are limited to aseptically opening ampuls, penetrating sterile stoppers on vials with sterile needles and syringes, and transferring sterile liquids in sterile syringes to sterile administration devices and packages of other sterile products.
         4. (iv) For a low-risk preparation, in the absence of passing a sterility test, the storage periods cannot exceed the following periods: before administration, 48 hours at controlled room temperature, for not more than 14 days if stored in cold temperatures, and for 45 days if stored in a frozen state at minus 20 degrees Celsius or colder). For delayed activation device systems, the storage period begins when the device is activated.

      2. (B) Examples of low-risk compounding include the following.

         1. (i) Single transfers of sterile dosage forms from ampuls, bottles, bags, and vials using sterile syringes with sterile needles, other administration devices, and other sterile containers. The contents of ampuls require sterile filtration to remove glass particles.
         2. (ii) Manually measuring and mixing no more than three manufactured products to compound drug admixtures and nutritional solutions.

   2. (2) Medium-risk level compounded sterile pharmaceuticals.

      1. (A) Medium-risk level compounded sterile pharmaceuticals are those compounded aseptically under low-risk conditions and one or more of the of the following conditions exists.

         1. (i) Multiple individual or small doses of sterile products are combined or pooled to prepare a compounded sterile pharmaceutical that will be administered either to multiple patients or to one patient on multiple occasions.
         2. (ii) The compounding process includes complex aseptic manipulations other than the single-volume transfer.
         3. (iii) The compounding process requires unusually long duration, such as that required to complete the dissolution or homogenous mixing.
         4. (iv) The sterile compounded pharmaceutical's do not contain broad-spectrum bacteriostatic substances, and they are administered over several days.
         5. (v) For a medium-risk preparation, in the absence of passing sterility test, the storage periods cannot exceed the following time periods: before administration, the compounded sterile preparations are properly stored and are exposed for not more than 30 hours at controlled room temperature for not more than 7 days at a cold temperature, and for 45 days in solid frozen state at minus 20 degrees or colder.

      2. (B) Examples of medium-risk compounding include the following.

         1. (i) Compounding of total parenteral nutrition fluids using a manual or automated device during which there are multiple injections, detachments, and attachments of nutrient source products to the device or machine to deliver all nutritional components to a final sterile container.
         2. (ii) Filling of reservoirs of injection and infusion devices with multiple sterile drug products and evacuations of air from those reservoirs before the filled device is dispensed.
         3. (iii) Filling of reservoirs of injection and infusion devices with volumes of sterile drug solutions that will be administered over several days at ambient temperatures between 25 and 40 degrees Celsius (77 and 104 degrees Fahrenheit).
         4. (iv) Transfer of volumes from multiple ampuls or vials into a single, final sterile container or product.

   3. (3) High-risk level compounded sterile pharmaceuticals.

      1. (A) High-risk level compounded sterile pharmaceuticals are those compounded under any of the following conditions.

         1. (i) Non-sterile ingredients, including manufactured products are incorporated, or a non-sterile device is employed before terminal sterilization.
         2. (ii) Sterile ingredients, components, devices, and mixtures are exposed to air quality inferior to ISO Class 5. This includes storage in environments inferior to ISO Class 5 of opened or partially used packages of manufactured sterile products that lack antimicrobial preservatives.
         3. (iii) Non-sterile preparations are exposed no more than 6 hours before being sterilized.
         4. (iv) It is assumed, and not verified by examination of labeling and documentation from suppliers or by direct determination, that the chemical purity and content strength of ingredients meet their original or compendial specifications in unopened or in opened packages of bulk ingredients.
         5. (v) For a high-risk preparation, in the absence of passing sterility test, the storage periods cannot exceed the following time periods: before administration, the compounded sterile preparations are properly stored and are exposed for not more than 24 hours at controlled room temperature for not more than 3 days at a cold temperature, and for 45 days in solid frozen state at minus 20 degrees or colder.

      2. (B) Examples of high-risk compounding include the following.

         1. (i) Dissolving non-sterile bulk drug and nutrient powders to make solutions, which will be terminally sterilized.
         2. (ii) Sterile ingredients, components, devices, and mixtures are exposed to air quality inferior to ISO Class 5. This includes storage in environments inferior to ISO Class 5 of opened or partially used packages of manufactured sterile products that lack antimicrobial preservatives.
         3. (iii) Measuring and mixing sterile ingredients in non-sterile devices before sterilization is performed.
         4. (iv) Assuming, without appropriate evidence or direct determination, that packages of bulk ingredients contain at least 95% by weight of their active chemical moiety and have not been contaminated or adulterated between uses.

3. (c) Environment.

   1. (1) Generic Substitution. A pharmacist may substitute on a prescription drug order issued for a brand name product provided the substitution is authorized and performed in compliance with Chapter 309 of this title (relating to Generic Substitution).

   2. (2) Special requirements for the compounding of sterile radiopharmaceuticals. When the pharmacy compounds sterile radiopharmaceuticals, the following is applicable.

      1. (A) A drug dispensed pursuant to a radioactive prescription drug order shall be dispensed in an appropriate immediate inner container as follows.

         1. (i) If a drug is susceptible to light, the drug shall be dispensed in a light-resistant container.
         2. (ii) If a drug is susceptible to moisture, the drug shall be dispensed in a tight container.
         3. (iii) The container should not interact physically or chemically with the drug product placed in it so as to alter the strength, quality, or purity of the drug beyond the official requirements.

      2. (B) Controlled area.

         1. (i) Low and Medium Risk Preparations. The pharmacy shall have a designated controlled area for the compounding of sterile radiopharmaceuticals that is functionally separate from areas for the preparation of non-sterile pharmaceuticals and is constructed to minimize the opportunities for particulate and microbial contamination. This controlled area for the preparation of sterile pharmaceuticals shall:

            1. (I) have a controlled environment that is aseptic or contains an aseptic environmental control device(s). If the aseptic environmental control device is located within the controlled area, the controlled area must extend a minimum of six feet from the device and clearly marked to identify the separation between the controlled and non-controlled area;
            2. (II) be clean, well lighted, and of sufficient size to support sterile compounding activities;
            3. (III) be used only for the compounding of sterile pharmaceuticals;
            4. (IV) be designed to avoid outside traffic and air flow;
            5. (V) be designed such that hand sanitizing and gowning occurs outside the controlled area but accessible without use of the hands of the compounding personnel;
            6. (VI) have non-porous and washable floors or floor covering to enable regular disinfection;
            7. (VII) be ventilated in a manner not interfering with aseptic environmental control conditions;
            8. (VIII) have walls, ceilings, and fixtures, shelving, counters, and cabinets that are smooth, impervious, free from cracks and crevices, and nonshedding. (acoustical ceiling tiles that are coated with an acrylic paint are acceptable);
            9. (IX) have drugs and supplies stored on shelving areas above the floor to permit adequate floor cleaning; and
            10. (X) contain only the appropriate compounding supplies and not be used for bulk storage for supplies and materials. Objects that shed particles may not be brought into the controlled area.
         2. (ii) High-risk Preparations. In addition to the requirements in subclause (I), when high-risk preparations are compounded, the aseptic environment control device(s) shall be located in a controlled area that maintains at least an ISO Class 8 (formerly Class 100,000) environment.
      3. (C) Automated compounding device(s). If automated compounding device(s) are used, the pharmacy shall have a method to calibrate and verify the accuracy of automated compounding devices used in aseptic processing and document the calibration and verification on a routine basis.

   3. (3) Security requirements.

      1. (A) All areas occupied by a pharmacy shall be capable of being locked by key or combination, so as to prevent access by unauthorized personnel when a pharmacist is not on-site.
      2. (B) The pharmacy may authorize personnel to gain access to that area of the pharmacy containing dispensed sterile radiopharmaceuticals, in the absence of the pharmacist, for the purpose of retrieving dispensed prescriptions to deliver to patients. If the pharmacy allows such after-hours access, the area containing the dispensed sterile radiopharmaceuticals shall be an enclosed and lockable area separate from the area containing undispensed prescription drugs. A list of the authorized personnel having such access shall be in the pharmacy's policy and procedure manual.
      3. (C) Each pharmacist while on duty shall be responsible for the security of the prescription department, including provisions for effective control against theft or diversion of prescription drugs, and records for such drugs

4. (d) Prescription dispensing and delivery.

   1. (1) Generic Substitution. A pharmacist may substitute on a prescription drug order issued for a brand name product provided the substitution is authorized and performed in compliance with Chapter 309 of this title (relating to Generic Substitution).

   2. (2) Prescription containers (immediate inner containers).

      1. (A) A drug dispensed pursuant to a radioactive prescription drug order shall be dispensed in an appropriate immediate inner container as follows.

         1. (i) If a drug is susceptible to light, the drug shall be dispensed in a light-resistant container.
         2. (ii) If a drug is susceptible to moisture, the drug shall be dispensed in a tight container.
         3. (iii) The container should not interact physically or chemically with the drug product placed in it so as to alter the strength, quality, or purity of the drug beyond the official requirements.
      2. (B) Immediate inner prescription containers or closures shall not be re-used.

   3. (3) Delivery containers (outer containers).

      1. (A) Prescription containers may be placed in suitable containers for delivery which will transport the radiopharmaceutical safely in compliance with all applicable laws and regulations.
      2. (B) Delivery containers may be re-used provided they are maintained in a manner to prevent cross contamination.

   4. (4) Labeling.

      1. (A) The immediate inner container of a radiopharmaceutical shall be labeled with:

         1. (i) standard radiation symbol;
         2. (ii) the words "caution-radioactive material";
         3. (iii) the name of the radiopharmaceutical; and
         4. (iv) the unique identification number of the prescription.

      2. (B) The outer container of a radiopharmaceutical shall be labeled with:

         1. (i) the name, address, and phone number of the pharmacy;
         2. (ii) the date dispensed;
         3. (iii) the directions for use, if applicable;
         4. (iv) the unique identification number of the prescription;
         5. (v) the name of the patient if known, or the statement, "for physician use" if the patient is unknown;
         6. (vi) the standard radiation symbol;
         7. (vii) the words "caution-radioactive material";
         8. (viii) the name of the radiopharmaceutical;
         9. (ix) the amount of radioactive material contained in millicuries (mCi), microcuries (uCi), or bequerels (Bq) and the corresponding time that applies to this activity, if different from the requested calibration date and time;
         10. (x) the name or initials of the person preparing the product and the authorized nuclear pharmacist who checked and released the final product unless documents are maintained in the pharmacy identifying these individuals for each prescription dispensed;
         11. (xi) if a liquid, the volume in milliliters;
         12. (xii) the requested calibration date and time; and
         13. (xiii) the expiration date and/or time.
      3. (C) The amount of radioactivity shall be determined by radiometric methods for each individual preparation immediately at the time of dispensing and calculations shall be made to determine the amount of activity that will be present at the requested calibration date and time, due to radioactive decay in the intervening period, and this activity and time shall be placed on the label per requirements set out in paragraph (4) of this subsection.

5. (e) Pharmaceutical Care Services.

   1. (1) The following minimum level of pharmaceutical care services shall be provided whenever a therapeutic prescription drug order is dispensed and, when in the professional judgement of the pharmacist dispensing a diagnostic prescription drug order, the services are necessary to protect the patient's health while striving to produce positive patient outcomes. When it is determined that the following services are necessary, the dispensing pharmacist shall assure that efforts are made to gather the information necessary to properly perform the services.

      1. (A) Drug utilization review. A systematic ongoing process of drug utilization review shall be designed, followed, and documented to increase the probability of desired patient outcomes and decrease the probability of undesired outcomes from drug therapy with radiopharmaceuticals.

      2. (B) Drug regimen review.

         1. (i) For the purpose of promoting therapeutic appropriateness, an authorized nuclear pharmacist shall, prior to or at the time of dispensing, evaluate therapeutic prescription drug orders and patient medication history for:

            1. (I) known allergies;
            2. (II) rational therapy contraindications;
            3. (III) reasonable dose and route of administration;
            4. (IV) reasonable directions for use;
            5. (V) duplication of therapy;
            6. (VI) drug-drug interactions;
            7. (VII) drug-food interactions;
            8. (VIII) drug-disease interactions;
            9. (IX) adverse drug reactions;
            10. (X) proper utilization, including overutilization or underutilization; and
            11. (XI) clinical laboratory or clinical monitoring methods to monitor and evaluate drug effectiveness, side effects, toxicity, or adverse effects, and appropriateness to continued use of the drug in its current regimen.
         2. (ii) Upon identifying any clinically significant conditions, situations, or items listed in clause (i) of this subparagraph, the authorized nuclear pharmacist shall take appropriate steps to avoid or resolve the problem including consultation with the prescribing practitioner.
         3. (iii) The drug regimen review may be conducted by remotely accessing the pharmacy's electronic data base from outside the pharmacy by an individual Texas licensed pharmacist employee of the pharmacy, provided the pharmacy establishes controls to protect the privacy of the patient and the security of confidential records.

   2. (2) Other pharmaceutical care services which may be provided by authorized nuclear pharmacists include, but are not limited to, the following:

      1. (A) managing drug therapy as delegated by a practitioner as allowed under the provisions of the Medical Practice Act;
      2. (B) managing patient compliance programs;
      3. (C) providing preventative health care services; and
      4. (D) providing case management of patients who are being treated with high-risk or high-cost drugs, or who are considered "high risk" due to their age, medical condition, family history, or related concern.

6. (f) Equipment. The following minimum equipment is required in a nuclear pharmacy:

   1. (1) vertical laminar flow hood;
   2. (2) dose calibrator;
   3. (3) refrigerator and a system or device (i.e., thermometer) to monitor the temperature and humidity to ensure that proper storage requirements are met, if sterile pharmaceuticals are stored in the refrigerator;
   4. (4) Class A prescription balance, and accurate weights or balance of greater sensitivity if compounding occurs in the pharmacy which requires weighing;
   5. (5) scintillation analyzer;
   6. (6) microscope and hemocytometer;

   7. (7) equipment and utensils necessary for the proper compounding of prescription drug or medication orders. Such equipment and utensils used in the compounding process shall be:

      1. (A) of appropriate design, appropriate capacity, and be operated within designed operational limits;
      2. (B) of suitable composition so that surfaces that contact components, in-process material, or drug products shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond acceptable standards;
      3. (C) cleaned and sanitized immediately prior to each use; and
      4. (D) routinely inspected, calibrated (if necessary), or checked to ensure proper performance;
   8. (8) appropriate disposal containers for used needles, syringes, etc., and if applicable, cytotoxic waste from the preparation of chemotherapeutic agents, and/or biohazardous waste;

   9. (9) all necessary supplies, including:

      1. (A) disposable needles, syringes, and other aseptic mixing;
      2. (B) disinfectant cleaning solutions;
      3. (C) hand washing agents with bactericidal action;
      4. (D) disposable, lint free towels or wipes;
      5. (E) appropriate filters and filtration equipment;
      6. (F) cytotoxic spill kits, if applicable; and
      7. (G) masks, caps, coveralls or gowns with tight cuffs, shoe covers, and gloves, as applicable.
   10. (10) adequate glassware, utensils, gloves, syringe shields and remote handling devices, and adequate equipment for product quality control;
   11. (11) adequate shielding material;
   12. (12) typewriter or comparable equipment;
   13. (13) radiation dosimeters for visitors and personnel and log entry book;
   14. (14) exhaust/fume hood with monitor, for storage and handling of all volatile radioactive drugs if applicable, to be determined by the Texas Radiation Control Bureau;
   15. (15) calculator; and
   16. (16) adequate radiation monitor(s).

7. (g) Library. A nuclear pharmacy shall maintain a reference library which shall include the following in hard copy or electronic format:

   1. (1) United States Pharmacopoeia/National Formulary with supplements;
   2. (2) federal and state laws and regulations relating to Texas pharmacy;
   3. (3) Texas Regulations for Control of Radiation;
   4. (4) reference on the safe handling of radioactive materials;
   5. (5) a minimum of three texts dealing with nuclear medicine science;
   6. (6) reference on sterile product preparation; and
   7. (7) Code of Federal Regulations, Title 49, Parts 106-199, with recent amendments.

8. (h) Radiopharmaceuticals and/or radioactive materials.

   1. (1) General requirements.

      1. (A) Radiopharmaceuticals may only be dispensed pursuant to a radioactive prescription drug order.
      2. (B) An authorized nuclear pharmacist may distribute radiopharmaceuticals to authorized users for patient use. A nuclear pharmacy may also furnish radiopharmaceuticals for departmental or physicians' use if such authorized users maintain a Texas radioactive materials license, and the radiopharmaceutical is labeled "for physician use," provided such distribution is documented in the control system.
      3. (C) An authorized nuclear pharmacist may transfer to authorized users radioactive materials not intended for drug use in accordance with Part 41 of the Texas Regulations for Control of Radiation, Texas Department of Health.
      4. (D) The transportation of radioactive materials from the nuclear pharmacy must be in accordance with current state and federal transportation regulations.

   2. (2) Procurement and storage.

      1. (A) The pharmacist-in-charge shall have the responsibility for the procurement and storage of drugs, but may receive input from other appropriate staff relative to such responsibility.
      2. (B) Prescription drugs and devices shall be stored within the prescription department or a locked storage area.

      3. (C) All drugs shall be stored at the proper temperature, as defined by the following terms.

         1. (i) Cold--Any temperature not exceeding 8 degrees Centigrade (46 degrees Fahrenheit). A refrigerator is a cold place in which the temperature is maintained thermostatically between 2 and 8 degrees Centigrade (36 and 46 degrees Fahrenheit). A freezer is a cold place in which the temperature is maintained thermostatically between -20 and -10 degrees Centigrade (-4 and -14 degrees Fahrenheit).
         2. (ii) Cool--Any temperature between 8 and 15 degrees Centigrade (46 and 59 degrees Fahrenheit). An article for which storage in a cool place is directed may, alternatively, be stored in a refrigerator unless otherwise specified in the labeling.
         3. (iii) Room temperature--The temperature prevailing in a working area. Controlled room temperature is a temperature thermostatically between 15 and 30 degrees Centigrade (59 and 86 degrees Fahrenheit).
         4. (iv) Warm--Any temperature between 30 and 40 degrees Centigrade (86 and 104 degrees Fahrenheit).
         5. (v) Excessive heat--Temperature above 40 degrees Centigrade (104 degrees Fahrenheit).
         6. (vi) Protection from freezing where, in addition to the risk of breakage of the container, freezing subjects a product to loss of strength or potency, or to destructive alteration of the dosage form, the container label bears an appropriate instruction to protect the product from freezing.

   3. (3) Out-of-date and other unusable drugs or devices.

      1. (A) Any drug or device bearing an expiration date shall not be dispensed beyond the expiration date of the drug or device.
      2. (B) Outdated and other unusable drugs or devices shall be removed from dispensing stock and shall be quarantined together until such drugs or devices are disposed of properly.

9. (i) Loading bulk drugs into automated compounding devices.

   1. (1) Automated compounding device may be loaded with bulk drugs only by an authorized nuclear pharmacist or by supportive personnel under the direction and direct supervision of an authorized pharmacist.
   2. (2) The label of an automated compounding device container shall indicate the brand name and strength of the drug; or if no brand name, then the generic name, strength, and name of the manufacturer or distributor.

   3. (3) Records of loading bulk drugs into an automated compounding device shall be maintained to show:

      1. (A) name of the drug, strength, and dosage form;
      2. (B) manufacturer or distributor;
      3. (C) manufacturer's lot number;
      4. (D) expiration date;
      5. (E) quantity added to the automated compounding device;
      6. (F) date of loading;
      7. (G) name, initials, or electronic signature of the person loading the automated compounding device; and
      8. (H) name, initials, or electronic signature of the responsible authorized nuclear pharmacist.
   4. (4) The automated compounding device shall not be used until an authorized nuclear pharmacist verifies that the system is properly loaded and affixes his or her signature or electronic signature to the record specified in paragraph (3) of this subsection.

10. (j) Sterile radiopharmaceuticals.

    1. (1) Expiration date.

       1. (A) The expiration date assigned shall be based on:

          1. (i) established manufacturer's guidelines;
          2. (ii) published literature; or
          3. (iii) in-house or contracted stability studies.
       2. (B) The method for establishing expiration dates shall be documented.

    2. (2) Radioactive Drug Quality control. There shall be a documented, ongoing quality control program that monitors and evaluates personnel performance, equipment and facilities. Procedures shall be in place to assure that the pharmacy is capable of consistently preparing radiopharmaceuticals which are sterile and stable. Quality control procedures shall include, but are not limited to, the following:

       1. (A) recall procedures;
       2. (B) storage and dating;
       3. (C) documentation of appropriate functioning of refrigerator, freezer, and other equipment;
       4. (D) documentation of aseptic environmental control device(s) certification at least every year and the regular replacement of pre-filters as necessary;
       5. (E) a process to evaluate and confirm the quality of the prepared radiopharmaceutical; and
       6. (F) documentation of facility maintenance such as cleaning and environmental testing.

Source Note:The provisions of this §291.54 adopted to be effective March 19, 1998, 23 TexReg 2815; amended to be effective June 1, 2002, 27 TexReg 1781; amended to be effective June 23, 2003, 28 TexReg 4638; amended to be effective June 6, 2004, 29 TexReg 5362.