Texas Occupations Code

§ 562.151 — DEFINITIONS

OC § 562.151Title 3. HEALTH PROFESSIONS · Part J. PHARMACY AND PHARMACISTS · Ch. 562. PRACTICE BY LICENSE HOLDER · Art. D. COMPOUNDED AND PREPACKAGED DRUGS

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In this subchapter:

(1)"Office use" means the provision and administration of a compounded drug to a patient by a practitioner in the practitioner's office or by the practitioner in a health care facility or treatment setting, including a hospital, ambulatory surgical center, or pharmacy in accordance with Chapter 563.

(2)"Prepackaging" means the act of repackaging and relabeling quantities of drug products from a manufacturer's original container into unit dose packaging or a multiple dose container for distribution within a facility licensed as a Class C pharmacy or to other pharmacies under common ownership for distribution within those facilities. The term as defined does not prohibit the prepackaging of drug products for use within other pharmacy classes.

(3)"Reasonable quantity" with reference to drug compounding means an amount of a drug that:

(A)does not exceed the amount a practitioner anticipates may be used in the practitioner's office before the expiration date of the drug;

(B)is reasonable considering the intended use of the compounded drug and the nature of the practitioner's practice; and

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Legislative history

Acts 2005, 79th Leg., Ch. 28 (S.B. 492), Sec. 4, eff. September 1, 2005.