Module 3 - Strategic case studies in practice

ATTACHMENT A 25

REGULATORY REQUIREMENTS

1.

The Federal Food, Drug, and Cosmetic Act

a.

Section 501

A drug or device shall be deemed to be adulterated “if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health” (section 501(a)(3)); or “if it is a drug and the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this Act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess (section 501(a)(2)(B)).

b.

Section 502

A drug or device shall be deemed to be misbranded:

C “[i]f it purports to be a drug the name of which is recognized in an official compendium, unless it is packaged and labeled as prescribed therein” (section 502(g))

C “[i]f it is a drug and its container is so made, formed, or filled as to be misleading” (section 502(i)(1))

C “[i]f it is a drug and its packaging or labeling is in violation of an applicable regulation issued pursuant to section 3 or 4 of the Poison Prevention Packaging Act of 1970" (section 502(p))

c.

Section 505

“No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to subsection (b) or (j) is effective with respect to such drug” (section 505(a)).

Section 505(b)(1)(D) requires "a full description of the methods used in, and the

Applicants should check the appropriate sources directly for the most up-to-date information. 25

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