To amend the Federal Food, Drug, and Cosmetic Act to provide for the compounding of drug products.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Verifying Authority and Legality In Drug Compounding Act of 2012''.
SEC. 2. APPLICATION OF FEDERAL LAW TO PRACTICE OF PHARMACY COMPOUNDING.
(a) Amendment.--Section 503A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353a) is amended to read as follows:
``SEC. 503A. PHARMACY COMPOUNDING.
``(a) In General.--Sections 501(a)(2)(B) and 505 shall not apply with respect to a drug product if each of the following applies: ``(1) The drug product is compounded for an identified individual patient based on the receipt of-- ``(A) a valid prescription order; or ``(B) a notation, approved by the prescribing practitioner, on the prescription order that a compounded product is necessary for the identified patient. ``(2) The drug product is compounded by a licensed pharmacist in a State-licensed pharmacy or a Federal facility, or by a licensed physician, pursuant to such prescription order or notation. ``(3) The drug product is compounded exclusively from-- ``(A) ingredients that comply with the standards of an applicable United States Pharmacopoeia or National Formulary monograph; or ``(B) if such a monograph does not exist, ingredients that are ingredients in a drug-- ``(i) for which an approval of an application filed under subsection (b) or (j) of section 505 is in effect; or ``(ii)...