(a) is engaged in the compounding of sterile drugs;

(b) is currently registered as an outsourcing facility with the Secretary of Health and Human Services; and

(c) complies with all applicable requirements of federal and state law, including the Federal Food, Drug and Cosmetic Act. 26. "Sterile drug" means a drug that is intended for parenteral administration, an ophthalmic or oral inhalation drug in aqueous format, or a drug that is required to be sterile under federal or state law. * 27. "Biological product" means a biological product as defined in subsection (i) of section 351 of the Public Health Service Act, 42 U.S.C. Section 262(i). * NB Expires October 23, 2022 * 28. "Interchangeable biological product" means a biological product licensed by the United States Food and Drug Administration pursuant to 42 U.S.C. Section 262(k)(4) as set forth in the latest edition or supplement of the United States Food and Drug Administration Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations, sometimes referred to as the "Purple Book," or a biological product determined by the United States Food and Drug Administration to be therapeutically equivalent as set forth in the latest edition or supplement of the United States Food and Drug Administration Approved Drug Products with Therapeutic Equivalence Evaluations, sometimes referred to as the "Orange Book." * NB Expires October 23, 2022