CPG Sec. 400.100 Drugs, Human - Failure to Register

Administrative guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.

CPG Sec. 400.100 Drugs, Human - Failure to Register
BACKGROUND:
Sections 510(b)&(c) of the Act requires the registration of all producers of drugs and devices. When the
legislation amending the Act was passed, Congress found and declared that in order to make the
regulation of interstate commerce in drugs effective, it was necessary to provide for the registration and
inspection of all establishments in which drugs were manufactured, prepared, propagated,
compounded, or processed; as the products of such establishments were likely to enter interstate
commerce; and that the regulation of interstate commerce in drugs without provision for registration
and inspection of establishments engaged only intrastate commerce of drugs would discriminate against
and depress interstate commerce of such drugs, and adversely burden, obstruct, and affect such
interstate commerce. Section 510(h) requires that each registrant be inspected for compliance every
two years.
REGULATORY ACTION GUIDANCE:
If an establishment is required to register and has failed to do so, then every reasonable effort should be
made to convince management to register the establishment on a voluntary basis during the initial
inspection. If this effort is unsuccessful then an informal discussion between the appropriate Division
Director within the Office of Pharmaceutical Quality Operations and the establishment's management
should be held. If registration is not accomplished after these initial steps then the issuance of a
*warning* letter will be considered by the *CDER*.
*Material between asterisks is new or revised*
Issued: 10/1/80
Revised: 3/95