The Investigations Operations Manual (IOM) is the primary policy guide for FDA investigators and other field employees to perform investigational activities in support of the agency's public health mission.
Although primarily used internally by FDA staff, it is available publicly so that regulated industry and other external stakeholders can better understand FDA operations. Here we mention two important topics - FD&C and Drug Inspections.
FEDERAL FOOD, DRUG, AND COSMETIC ACT
This Act, as amended, and its regulations provide the basic authority for most operations. Examinations, Investigations, and Samples - Collecting samples is an important and critical part of FDA's regulatory activities. While inspections and investigations may precede sample collection, a case under the law does not normally begin until a sample has been obtained. Proper sample collection is the keystone of effective enforcement action.
The basic authority for FDA to take samples falls under the statutory provisions of section 702(a) of the FD&C Act [21 USC 372(a)], which authorizes examinations and investigations for the purposes of this Act. For tobacco products, section 702(a)(1)(B) of the FD&C Act directs FDA to contract with states to inspect retailers within that state in connection with the enforcement of the Act when feasible.
Section 702(b) of the FD&C Act [21 USC 372(b)] requires FDA to furnish, upon request, a portion of an official sample for examination or analysis to any person named on the label of an article, the owner thereof, or his attorney or agent. In a precedent case, "United States v. 75 Cases, More or Less, Each Containing 24 Jars of Peanut Butter, the U.S. Circuit Court of Appeals for the Fourth Circuit held the taking of samples is authorized under section 702(b) of the FD&C Act [21 U.S.C. 372(b)], since this section "clearly contemplates the taking of samples." See Kleinfeld and Dunn 1938-1949 at 126. The FD&C Act also refers to samples in sections 704(c) and 704(d) [21 USC 374(c) and 374(d)].
FDA DRUG INSPECTIONS
In the case of drug inspections, FDA has explicit authority to address the delay, denial, limiting, or refusal of an inspection, under Section 707 of the Food and Drug Administration Safety and Innovation Act (FDASIA), which created new Section 501(j) of the FD&C Act [21 U.S.C. 351(j)]. Section 501(j) deems adulterated any drug that is manufactured in an establishment that delays, limits, denies or refuses to permit entry or inspection.
FDA issued draft guidance with examples of the types of conduct that FDA considers to be in violation of Section 501(j) of the FD&C Act. This guidance also specified that under certain circumstances delaying, denying, limiting or refusing a request for records in advance or in lieu of an inspection under Section 706 may also result in a manufacturer’s drugs being adulterated under the FD&C Act.
