Does FDA approve the information given out by pharmacies when I pick up my medicine?
FDA reviews and approves some of the information consumers may receive with their medication. When picking up medicine at a pharmacy, consumers may receive information about the drug, including some or all of the following:
- Medication Guides are information sheets, developed by the manufacturer, but required by FDA for medications FDA has determined have particularly noteworthy risks. If a Medication Guide has been developed for the medicine, it must be given out with the drug. Medication Guides are reviewed and approved by FDA.
- Consumer Medication Information (CMI) is usually written by drug information companies and provided to pharmacies that use their services. Pharmacies sometimes modify this information, such as shortening it to make it easier to read. Pharmacies usually provide CMI with every prescription drug they dispense. CMI is currently not reviewed or approved by FDA. FDA is considering how to make CMI more useful and more uniform from pharmacy to pharmacy.
- A small number of prescription products are shipped with Patient Package Inserts (PPIs), which are developed by the manufacturer and contain risk information about the drug in consumer-friendly language. PPIs are given out with certain products, such as birth control pills and products that contain similar ingredients to them (for example, products that contain estrogen). PPIs are also reviewed and approved by FDA.
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- Materials from Webinar on Access to Investigational Drugs
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- FDA Basic Video: Interview with John Jenkins on New Drugs (Video)
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- What is a Warning Letter?
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