ABSTRACT
According to the Federal Food, Drug, and Cosmetic Act (the Act), Section 501(a)(3), a drug is 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.” In addition, section 502 of the Act states that a drug is considered misbranded if there are packaging omissions. Also, section 505 of the Act requires a full description of the methods used in, and the facilities and controls used for, the packaging of drugs. Section 505(b)(1)(D) of the Act states that an application shall include a full description of the methods used in the manufacturing, processing, and packing of such drug. This includes facilities and controls used in the packaging a drug product.
