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Which amendment allowed for the removal of grandfathered drugs from the market until safety can be proven if the drugs were thought to be hazardous to the public?
When did the FDA initiate a scientific review known as the OTC Drug Review which reviewed 300,000 OTC products and started the use of therapeutic OTC classes?
True or False: A new drug can come to the OTC product only if it is Rx first, then reclassified to nonprescription.
Which of the following was not approved directly as an OTC drug, but rather was an Rx item first: Nicotrol Patch, Motrin 200 mg, Nicotrol Lozenge, or Alli.
What provides the FDA with evidence that a new drug is safe and effective for intended use and shows that the drug's benefits outweigh the risks?
What must a second manufacturer submit if they want to manufacture a drug already approved by the FDA?
True or False: Manufacturers can only use certain ingredients with FDA approval when manufacturing a drug.
No mandated timelines
Which of the following is a perceived benefit from a manufacturer's standpoint to market a drug from the OTC Monograph process: Confidentiality, Marketing exclusivity, or no mandated timelines?
Which category of OTC ingredient is considered to have sufficient evidence of safety and effectiveness?
Indications, Warnings, Directions for use
What are the three labeling requirements for OTC products?
True or False: OTC products that do not have a dosage limit and are stable for at least 3 years do not have to indicate an expiration date on its labeling.
Dulcolax Stool Softener
Which of the following contain(s) docusate sodium: Dulcolax Stool Softener, Dulcolax tablets, or Dulcolax Milk of Magnesia.
Manufacturer, Packer or Distributor
The Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006 mandates who to report serious OTC adverse events?
True or False: The FDA can prevent further sale of an OTC drug if it's misbranded, adulterated, or unapproved without court injunction.
False (notifying consumers if necessary)
True or False: Pharmacists are not responsible for any part of an OTC product recall.
What classification of OTC product recall is defined by a product that is unlikely to cause any adverse health reaction but violates FDA labeling or manufacturing regulations?
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