Question

Which of the following is true:

A. As an agency created under administrative law, FDA can make changes to the Food Drug and

Cosmetic Act through rule making.

B. The relevant regulations for FDA are not just found in 21 CFR but also 45 CFR

Guidances explain the law and regulations and the “advice” they provide is as binding as a

regulation.

C. Regulations do not have the same enforceability as Statues, they are only one way to comply

with the law.

D. New guidances must go through the same notice‐and‐comment rulemaking required of new

regulations

Answer 1

The United States Federal Food, Drug and Cosmetic Act (FFDCA/FDCA/FD&C) is the laws passed by United State Congress in 1938. The authority of this section was given to US Food and Drug Administration (FDA) for the safety measuses of food, cosmetic, drugs, medicines, and such other materials. The regulations are governed by US congress and interpreted by FDA. Title 21 of the Code of Federal Regulations (21 CFR) governs food and drugs within US for the FDA, DEA and ONDCP whereas Title 45 of CFR is for the public welfare by the department of health and human services. New guidances should follow Good guidance practices and 21 CFR for guideline agenda and then publicly released for notice-and-comment rulemaking.

In this question, (A) and (D) both are right answers.