How will FDA deal with compounders that do not register as outsourcers but fail to comply with the requirements of section 503A of the FDCA?

11. How will FDA deal with compounders that do not register as outsourcers but fail to comply with the requirements of section 503A of the FDCA?

If a compounded drug does not qualify for the exemptions under either section 503A or 503B of the FDCA, it would be subject to all of the requirements of the FDCA that are applicable to drugs made by conventional manufacturers, including the new drug approval, adequate directions for use, and CGMP requirements.

FDA issued a draft guidance that describes FDA’s intention with regard to the provisions of section 503A that require rulemaking or other action to implement. This draft guidance also describes the provisions of the law that are applicable to compounded drugs that do not qualify for the exemptions described above, and the other provisions of the FDCA applicable to compounded drugs regardless of whether they qualify for the exemptions under section 503A.

source FDA Questions and Answers on Compounding