MPJE Study Guide 2026

Federal law requires prescription drug labeling to bear the statement 'Rx only,' indicating that the drug may only be dispensed pursuant to a valid prescription.

The FDA requires a standardized 'Drug Facts' label on all OTC medications, which must list, in a specific order, the active ingredient(s), uses, warnings, directions, and inactive ingredients. The purpose of each active ingredient must be stated. While the NDC, lot number, and expiration date are required on the packaging, they are not part of the standardized 'Drug Facts' panel itself.

Under the FD&C Act, a drug is adulterated if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it has been prepared under unsanitary conditions.

Products that are unsafe or flawed and may result in significant injury are subject to Class I recalls. Recalls under Class II are made for goods that might momentarily harm consumers' health. Products unlikely to cause any health issues are subject to Class III recalls.

Final prescription verification—the clinical check ensuring accuracy, appropriateness, and safety—is a pharmacist-only function and cannot be delegated to technicians.

For healthcare providers with direct treatment relationships, such as a pharmacy, HIPAA requires that they provide the NPP to the patient no later than the date of the first service delivery. The pharmacy must also make a good faith effort to obtain a written acknowledgment from the patient that they have received the notice. While posting the notice is also required, the key obligation upon first service is providing the copy and attempting to get acknowledgment.