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- Articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them.
- Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.
- Articles (other than food) intended to affect the structure or any function of the body of man or other animals
- Articles intended for use as a component of any article specified above.