When would the FDA require mandatory information ie a medica

When would the FDA require mandatory information, i.e., a medication guide?

Solution

When FDA intends to exercise enforcement discretion regarding when a Medication Guide must be provided with a drug or biological product that is dispensed to a healthcare professional for administration to a patient4 instead of being dispensed directly to the patient for self-administration or to the patient’s caregiver for administration to the patient. • When a Medication Guide will be required as part of a risk evaluation and mitigation strategy (REMS).

In 1998, FDA issued final regulations establishing requirements for the distribution of patient labeling for certain prescription drug and biological products used primarily on an outpatient basis without direct supervision by a healthcare professional (63 FR 66378, December 1, 1998). These regulations, codified in 21 CFR part 208, apply to certain drug and biological products that FDA determines pose a serious and significant public health concern requiring the distribution of FDA-approved patient medication information that is necessary to patients’ safe and effective use of the drug products (a Medication Guide). All Medication Guides are subject to the standard in § 208.1 and the requirements of part 208. Section 208.1(a) states that Medication Guides apply primarily to human prescription drug products used on an outpatient basis without direct supervision by a healthcare professional and are applicable to both new and refill prescriptions.

Section 208.1(c) authorizes FDA to require a Medication Guide if FDA determines one or more of the following circumstances exist: (1) The drug product is one for which patient labeling could help prevent serious adverse effects. (2) The drug product is one that has serious risk(s) (relative to benefits) of which patients should be made aware because information concerning the risks could affect patients’ decision to use, or continue to use, the product. (3) The drug product is important to health and patient adherence to directions for use is crucial to the drug’s effectiveness.