Replaces language in 21 U.S.C. 360eee(13) concerning homeopathic products, changing the phrase 'homeopathic drugs marketed in accordance with applicable guidance under this Act' to 'homeopathic drug products marketed in accordance with this Act.'

Revises the definition of 'nonprescription drug' in 21 U.S.C. 379aa(a)(2) to specify nonprescription drugs are not subject to section 503(b) or to approval under section 505, and to explicitly include a 'homeopathic drug product.'

Adds language to 42 U.S.C. 262(i)(1) stating that 'Such term does not include a homeopathic drug product (as defined in section 201 of the Federal Food, Drug, and Cosmetic Act).'

Inserts a new section 503E (Homeopathic drug products) into Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic Act. The new section defines which chapter provisions apply to homeopathic drug products, sets adulteration and manufacturing practice standards (including incorporation of the Homeopathic Pharmacopoeia of the United States or accredited voluntary consensus standards), prescribes labeling and misbranding rules, provides registration/listing designations, prohibits premarket approval for homeopathic drug products, establishes a Homeopathic Drug Product Advisory Committee and its membership/operations, requires Federal inspectors dealing with homeopathic drug products to be familiar with the section, and addresses non-preemption of State law and burden of proof.

Amends section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) by (1) revising paragraph (p) to insert an exception phrase, (2) inserting text into paragraph (v) before the terminal period, and (3) adding new paragraphs (tt) and (uu) to define 'homeopathic drug product' and 'homeopathic ingredient'.