; . 4. Definitions Subsection (e) of section 503A of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 353a ) is amended to read as follows: (e) Definitions In this section: (1) Compounding The term compounding does not include mixing, reconstituting, or other such acts that are performed in accordance with directions contained in approved labeling provided by the product’s manufacturer and other manufacturer directions consistent with that labeling. (2) Distribute or distribution The terms distribute or distribution do not include the act of dispensing of a compounded drug product in accordance with this section. (3) Dispense The term dispense means for a drug product compounded in accordance with this section, the act of the drug product leaving the facility in which it was compounded for delivery to a patient, patient’s agent, or health care facility (including a hospital, physician’s office, or other health care setting) pursuant to a valid prescription order for an identified patient. . 5. Applicability of records exemption for compounding pharmacies (a) In general Section 704(a)(2)(A) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 374(a)(2)(A) ) is amended to read as follows: (A) pharmacies which maintain establishments in conformance with any applicable local laws regulating the practice of pharmacy and medicine and, for compounding pharmacies, the provisions of section 503A, and which are regularly engaged in dispensing or distributing prescription drugs or devices, upon prescriptions or drug orders of practitioners licensed to administer such drugs or devices to patients under the care of such practitioners in the course of their professional practice, and which do not, either through a subsidiary or otherwise, manufacture, prepare, propagate, compound, or process drugs or devices for sale other than in the regular course of their business