The question of where, when, and how to label a product, whether it be a prescription drug, OTC product under an approved application, or an OTC product marketed under the monograph system has always been kind of a guessing game for manufacturers, packagers, and repackagers. Now, a new Guidance titled “Child-Resistant Packaging Statements in Drug Product Labeling” answers many of those questions and provides guidance as to how to be in compliance with the FDA regulatory scheme.
The Guidance notes (which is good background for all) that – “[i]n 1970, the Poison Prevention Packaging Act (PPPA) was enacted to protect children (under 5 years of age) from unintentional exposure to household substances, including food, drugs, and cosmetics. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), a drug that has packaging or labeling that is in violation of a regulation issued pursuant to Sections 3 or 4 of the PPPA, is deemed to be misbranded. FDA was responsible for enforcing the PPPA until 1973, when jurisdiction was transferred to the U.S. Consumer Product Safety Commission (CPSC). Because of FDA’s authority to regulate labeling for prescription and nonprescription drug products, if firms choose to make statements in their labeling for such products about child-resistant packaging, such statements must comply with FDA’s statutory and regulatory requirements.”
Also, it is important to note that, if a claim is made that the product meets the child-resistant standards of the PPPA and CPSC, then the FDA expects a sponsor to retain the data supporting such testing and also include a statement that the testing complies with the “standards set forth by the CPSC in 16 CFR 1700”. The FDA will not ask to see the testing, but requires that the statement of compliance be included in the application. In addition, for drug products marketed under the OTC monograph where no preapproval submission is required, the firm must maintain the data supporting the CRC testing that supports the claim. A full copy of the Guidance document can be found here.