Page:United States Statutes at Large Volume 111 Part 3.djvu/240

 Ill STAT. 2328 PUBLIC LAW 105-115—NOV. 21, 1997 (B) by redesignating subparagraphs (B) and (C) as subparagraphs (A) and (B), respectively. (2) Section 503(b)(3) (21 U.S.C. 353(b)(3)) is amended by striking "section 502(d) and". (3) Section 102(9)(A) of the Controlled Substances Act (21 U.S.C. 802(9)(A)) is amended— (A) in clause (i), by striking "(i)"; and (B) by striking "(ii)" and all that follows. SEC. 127. APPLICATION OF FEDERAL LAW TO PRACTICE OF PHAR- • MACY COMPOUNDING. (a) AMENDMENT.— Chapter V is amended by inserting after section 503 (21 U.S.C. 353) the following: 21 USC 353a. "SEC. 503A. PHARMACY COMPOUNDING. "(a) IN GENERAL.—Sections 501(a)(2)(B), 502(f)(1), and 505 shall not apply to a drug product if the drug product is compounded for an identified individual patient based on the unsolicited receipt of a valid prescription order or a notation, approved by the prescribing practitioner, on the prescription order that a compounded product is necessary for the identified patient, if the drug product meets the requirements of this section, and if the compounding— " (l)isby- "(A) a licensed pharmacist in a State licensed pharmacy or a Federal facility, or "(B) a licensed physician, on the prescription order for such individual patient made by a licensed physician or other licensed practitioner authorized by State law to prescribe drugs; or "(2)(A) is by a licensed pharmacist or licensed physician in limited quantities before the receipt of a valid prescription order for such individual patient; and "(B) is based on a history of the licensed pharmacist or licensed physician receiving valid prescription orders for the compounding of the drug product, which orders have been generated solely within an established relationship between— "(i) the licensed pharmacist or licensed physician; and "(ii)(I) such individual patient for whom the prescription order will be provided; or "(II) the physician or other licensed practitioner who will write such prescription order. " (b) COMPOUNDED DRUG. — "(1) LICENSED PHARMACIST AND LICENSED PHYSICIAN. — A drug product may be compounded under subsection (a) if the licensed pharmacist or licensed physician— "(A) compounds the drug product using bulk drug substances, as defined in regulations of the Secretary published at section 207.3(a)(4) of title 21 of the Code of Federal Regulations— "(i) that— "(I) comply with the standards of an applicable United States Pharmacopoeia or National Formulary monograph, if a monograph exists, and the United States Pharmacopoeia chapter on pharmacy compounding; "(II) if such a monograph does not exist, are drug substances that are components of drugs approved by the Secretary; or

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