By definition, a pharmaceutical grade substance is an FDA-approved veterinary or human drug. A database is available at http://www.accessdata.fda.gov/scripts/cder/drugsatfda.
NOTE: Drug compounds sold by chemical manufacturers (e.g., Sigma-Aldrich®) are typically reagent grade and NOT pharmaceutical grade.
Any non-FDA approved substance is therefore considered to be non-pharmaceutical grade and requires justification in the IACUC application. These substances are available in a spectrum of quality and consistency. The following order of choice should be applied:
- Drug compounded from an FDA-approved drug or an active pharmaceutical ingredient manufactured in conformance with current Good Manufacturing Practice and meeting United States Pharmacopeia/National Formulary/British Pharmacopeia (USP/NF/BP) standards. This includes drugs acquired from a Pharmacy Compounding Accreditation Board or FDA-registered compounding pharmacy.
- USP-grade chemical or substance used to formulate a needed dosage form (e.g., electrolytes, amino acids, DMSO, dextrose, or methylcellulose powder).
- Non-pharmaceutical grade or non-USP grade compounds: (e.g., analytical, or reagent grade chemicals, such as those from Sigma-Aldrich®; peptides; or oligonucleotides used to compound or formulate a needed dosage form).
NOTE: Dilutions or formulation modifications to an FDA-approved veterinary or human drug or biologic also require IACUC approval to ensure safety, efficacy, proper storage, and assignment of expiration dates.