The following words and terms, when used in these sections, shall have the following meanings, unless the context clearly indicates otherwise. Any term not defined in this section shall have the definition set forth in the Act, §5.

1. (1) Act--The Texas Pharmacy Act, Texas Civil Statutes, Article 4542a-1, as amended.

2. (2) Accurately as prescribed--Dispensing, delivering, and/or distributing a prescription drug order or radioactive prescription drug order:

   1. (A) to the correct patient (or agent of the patient) for whom the drug or device was prescribed;
   2. (B) with the correct drug in the correct strength, quantity, and dosage form ordered by the practitioner; and
   3. (C) with correct labeling (including directions for use) as ordered by the practitioner. Provided, however, that nothing herein shall prohibit pharmacist substitution if substitution is conducted in strict accordance with applicable laws and rules, including §40 of the Texas Pharmacy Act.

3. (3) Administer--The direct application of a prescription drug and/or radiopharmaceutical, by injection, inhalation, ingestion, or any other means to the body of a patient by:

   1. (A) a practitioner, an authorized agent under his supervision, or other person authorized by law; or
   2. (B) the patient at the direction of a practitioner.

4. (4) Airborne particulate cleanliness class--The level of cleanliness specified by the maximum allowable number of particles per cubic foot of air as specified in Federal Standard 209E, et seq. For example:

   1. (A) Class 100 is an atmospheric environment which contains less than 100 particles no greater than 0.5 microns in diameter per cubic foot of air;
   2. (B) Class 10,000 is an atmospheric environment which contains less than 10,000 particles no greater than 0.5 microns in diameter per cubic foot of air; and
   3. (C) Class 100,000 is an atmospheric environment which contains less than 100,000 particles no greater than 0.5 microns in diameter per cubic foot of air.
5. (5) Authentication of product history--Identifying the purchasing source, the intermediate handling, and the ultimate disposition of any component of a radioactive drug.
6. (6) Authorized nuclear pharmacist--A pharmacist who has completed the specialized training requirements specified by these rules for the preparation and distribution of radiopharmaceuticals.
7. (7) Authorized user--Any individual named on a Texas radioactive material license, issued by the Texas Department of Health, Bureau of Radiation Control.
8. (8) Automated compounding or drug dispensing device--An automated device that compounds, measures, counts, packages, and/or labels a specified quantity of dosage units for a designated drug product.
9. (9) Biological Safety Cabinet--Containment unit suitable for the preparation of low to moderate risk agents where there is a need for protection of the product, personnel, and environment, according to National Sanitation Foundation (NSF) Standard 49.
10. (10) Board--The Texas State Board of Pharmacy.
11. (11) Class B pharmacy license or nuclear pharmacy license--A license issued to a pharmacy dispensing or providing radioactive drugs or devices for administration to an ultimate user.
12. (12) Clean room--A room in which the concentration of airborne particles is controlled and there are one or more clean zones according to Federal Standard 209E, et seq.
13. (13) Clean zone--A defined space in which the concentration of airborne particles is controlled to meet a specified airborne particulate cleanliness class.
14. (14) Controlled area--A controlled area is the area designated for preparing sterile radiopharmaceuticals.
15. (15) Controlled substance--A drug, immediate precursor, or other substance listed in Schedules I-V or Penalty Groups 1-4 of the Texas Controlled Substances Act, as amended, or a drug, immediate precursor, or other substance included in Schedule I, II, III, IV, or V of the Federal Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended (Public Law 91-513).

16. (16) Dangerous drug--A device, drug, or radioactive drug that is unsafe for self medication and that is not included in Penalty Groups I through IV of Chapter 481 (Texas Controlled Substances Act). The term includes a device, drug, or radiopharmaceutical that bears or is required to bear the legend:

    1. (A) "Caution: Federal Law Prohibits Dispensing Without a Prescription"; or
    2. (B) "Caution: Federal Law Restricts This Drug To Be Used By or on the Order of a Licensed Veterinarian."
17. (17) Data communication device--An electronic device that receives electronic information from one source and transmits or routes it to another (e.g., bridge, router, switch, or gateway).
18. (18) Deliver or delivery--The actual, constructive, or attempted transfer of a prescription drug or device, radiopharmaceutical, or controlled substance from one person to another, whether or not for a consideration.

19. (19) Designated agent--

    1. (A) a licensed nurse, physician assistant, pharmacist, or other individual designated by a practitioner, and for whom the practitioner assumes legal responsibility, who communicates radioactive prescription drug orders to a pharmacist; or
    2. (B) a licensed nurse, physician assistant, or pharmacist employed in a health care facility to whom the practitioner communicates a radioactive prescription drug order.
20. (20) Device--An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related articles, including any component parts or accessory that is required under federal or state law to be ordered or prescribed by a practitioner.
21. (21) Diagnostic prescription drug order--A radioactive prescription drug order issued for a diagnostic purpose.
22. (22) Dispense--Preparing, packaging, compounding, or labeling for delivery a prescription drug or device, or a radiopharmaceutical in the course of professional practice to an ultimate user or his agent by or pursuant to the lawful order of a practitioner.
23. (23) Dispensing pharmacist--The authorized nuclear pharmacist responsible for the final check of the dispensed prescription before delivery to the patient.
24. (24) Distribute--The delivering of a prescription drug or device, or a radiopharmaceutical other than by administering or dispensing.
25. (25) Electronic radioactive prescription drug order--A radioactive prescription drug order which is transmitted by an electronic device to the receiver (pharmacy).
26. (26) Internal test assessment--Validation of tests for quality control necessary to insure the integrity of the test.
27. (27) Nuclear pharmacy technique--The mechanical ability required to perform the nonjudgmental, technical aspects of preparing and dispensing radiopharmaceuticals.

28. (28) Original prescription--The:

    1. (A) original written radioactive prescription drug orders; or
    2. (B) original verbal or electronic radioactive prescription drug orders reduced to writing either manually or electronically by the pharmacist.
29. (29) Pharmacist-in-charge--The pharmacist designated on a pharmacy license as the pharmacist who has the authority or responsibility for a pharmacy's compliance with laws and rules pertaining to the practice of pharmacy.
30. (30) Pharmacy technician/Supportive Personnel--Those individuals utilized in pharmacies whose responsibility it shall be to provide technical services that do not require professional judgment concerned with the preparation and distribution of drugs or radiopharmaceuticals under the direct supervision of and responsible to a pharmacist.
31. (31) Process validation--Documented evidence providing a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.
32. (32) Radiopharmaceutical--A prescription drug or device that exhibits spontaneous disintegration of unstable nuclei with the emission of a nuclear particle(s) or photon(s), including any nonradioactive reagent kit or nuclide generator that is intended to be used in preparation of any such substance.
33. (33) Radioactive drug quality control--The set of testing activities used to determine that the ingredients, components (e.g., containers), and final radiopharmaceutical prepared meets predetermined requirements with respect to identity, purity, non-pyrogenicity, and sterility and the interpretation of the resulting data in order to determine the feasibility for use in humans and animals including internal test assessment, authentication of product history, and the keeping of mandatory records.
34. (34) Radioactive drug service--The act of distributing radiopharmaceuticals; the participation in radiopharmaceutical selection and the performance of radiopharmaceutical drug reviews.
35. (35) Radioactive prescription drug order--An order from a practitioner or a practitioner's designated agent for a radiopharmaceutical to be dispensed.
36. (36) Sterile radiopharmaceutical--A dosage form of a radiopharmaceutical free from living micro-organisms.
37. (37) Therapeutic prescription drug order--A radioactive prescription drug order issued for a specific patient for a therapeutic purpose.
38. (38) Ultimate user--A person who has obtained and possesses a prescription drug or radiopharmaceutical for his or her own use or for the use of a member of his or her household.

Source Note:The provisions of this §291.52 adopted to be effective March 19, 1998, 23 TexReg 2815.