5 These regulations now apply to virtually all prescription drugs introduced to the market in the United States. 4 The latest requirements for “Content and Format of Labeling for Human Prescription Drug and Biological Products” went into effect on June 30, 2006, and are outlined in Title 21 of the Code of Federal Regulations (CFR), specifically part 201, sections 201.56 and 201.57. ![]() The PI is different from the Patient Package Insert (PPI), which contains information intended for patients, notwithstanding that the PPI may be required as part of the FDA-approved labeling for the drug. ![]() The regulations governing labeling of OTC medications, formalized in 1972, are different. 2 The rationale behind this doctrine is that the complexity of the information involving prescription drugs necessitates an intermediary who can explain or interpret the benefits and risks associated with the use of the drug to the ultimate user-the patient. Instead, when it comes to prescription drugs, the manufacturer’s duty is to provide prescribing physicians with information about the proper use and risks of the product so that the prescriber is then better equipped to educate the consumer/patient about the drug’s use and risks this is referred to as the learned intermediary doctrine. Although a manufacturer of any product generally carries the responsibility to warn the user about the risks associated with the product’s use, manufacturers of prescription drugs are not required to warn each patient who uses their products. 1 Thus, the importance of educating consumers about products they use is well recognized. The 1966 Fair Packaging and Labeling Act requires all consumer products in interstate commerce to be honestly and informatively labeled, with the FDA enforcing these provisions on foods, drugs, cosmetics, and medical devices. Its availability, ease of use, contents, and legal weight make the PI the resource that should often be the starting point when initiating a search for drug information. One important information source that pharmacists as well as other practitioners have access to, but sometimes overlook, is the drug’s label, also known as the prescribing information or the package insert (PI). Thus, when searching for drug information, many times the problem facing a pharmacist is not a lack of resources, but rather too many resources from which to choose. Specifically, pharmacists have access to drug information from a variety of resources, including print publications, subscription-based electronic databases (e.g., Clinical Pharmacology, Facts & Comparisons eAnswers, Lexicomp Online, Micromedex Solutions, UpToDate), and/or free Internet resources (e.g.,, ). A vast amount of practice-related information is available to today’s healthcare practitioner.
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