FD&C Act Section 301 - Prohibited Acts

What it says

Section 301 enumerates prohibited acts under the Act, including the introduction into interstate commerce of any drug that is adulterated or misbranded, the adulteration or misbranding of a drug while held for sale after shipment, and refusal to permit a properly authorised inspection.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• This section is where the adulteration and misbranding determinations under Sections 501 and 502 actually become legally actionable prohibited conduct, connecting the definitional provisions to enforceable legal violations.
• The prohibition applies broadly across the supply chain, covering not just the original manufacturer but potentially others who adulterate or misbrand a product while it is held for sale after initial shipment.
• Criminal liability can attach to violations of this section in certain circumstances, distinguishing it from purely civil or administrative regulatory consequences.

What FDA inspectors look for

• This is a foundational statutory enforcement provision rather than a specific manufacturing practice - it is the legal mechanism through which adulteration and misbranding determinations become the basis for actual FDA enforcement action.
• The practical relevance for quality professionals is understanding that manufacturing and labeling deficiencies are not merely internal compliance matters but can constitute specific prohibited acts carrying legal consequences.

Related regulations