Guidance For Industry - Assessment Of Abuse Potential Of Drugs - U.s. Department Of Health And Human Services - 2017 Page 15
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37Contains Nonbinding Recommendations
A. Chemistry and Manufacturing
Data from the chemistry, manufacturing, and controls (CMC) section of the NDA that are
relevant to the abuse potential of the drug substance and drug product under investigation should
be submitted as part of, or be cross-referenced to, the abuse potential assessment section.
The chemistry part of the abuse potential assessment section for an NME should include the
following information about the drug substance:
• Chemical structure
• Molecular formula and molecular weight (salt and base, as applicable)
• Chemical Abstracts Service (CAS) Registry Number(s)
• Chemical name (such as the name generated using the nomenclature conventions of the
International Union of Pure and Applied Chemistry (IUPAC), the name listed in the
United States Adopted Names (USAN) Counsel dictionary, drug development program
codes, and established or generic names)
• Description of isomers, e.g., optical, existence of diastereomers, geometric, and
positional isomers
• Physicochemical properties of the drug substance, for both salt and free acid/base forms,
e.g., melting point, boiling point, dissociation equilibrium constants, and solubility in
various solvents, such as aqueous media, buffered solutions, alcohol, and organic
solvents
• Description of the manufacturing process for the drug substance, specifically addressing
whether it involves a precursor that is a controlled substance or a List I or List II
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chemical (21 CFR 1310.02)
The composition and physicochemical properties of the drug product should be discussed in the
abuse potential assessment section in the context of their possible impact on the abuse potential
of the drug substance, and relative to the drug schedule of already-marketed formulations
containing the same drug substance if it is a controlled substance.
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Note that if the new drug involves an immediate precursor to a drug already controlled under the CSA it may be
subject to scheduling by a different process than that described above at III.E. See 21 U.S.C. 811(e), 21 CFR
1308.47.
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