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36 terms

Self Care Legal and Regulatory Issues

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FDCA 1938
Which act mandated safety of OTC drugs?
Durham-Humphrey 1951
Which amendment established 2 separate classes of drugs?
Kefauver-Harris 1962
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?
1972
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?
False
True or False: A new drug can come to the OTC product only if it is Rx first, then reclassified to nonprescription.
FDCA 1938
Which act requires all new drugs to have an NDA?
Nicotrol Patch
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.
NDA
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?
Manufacturing
What preserves a drug's identity, strength, quality, and purity?
True
True or False: An approved NDA is manufacturer specific.
aNDA
What must a second manufacturer submit if they want to manufacture a drug already approved by the FDA?
OTC Monograph
What develops a listing of therapeutic OTC classes for GRAS/E ingredients?
False
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?
True
True or False: The OTC Monograph process is a public process.
False
True of False: The OTC Monograph process requires pre-market approval.
True
True or False: The OTC Monograph process does not require actual use studies.
Category I
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?
sNDA
What does a manufacturer need to submit in order to request an Rx product be switched to OTC?
False (over 80)
True or False: Only 40 drugs have switched from Rx to OTC since 1976.
True
True or False: An OTC product lacking the "Drug Facts" box would be considered misbranded.
Use
What term is required on OTC Drug Fact Labeling in place of the term "indications"?
True
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.
True
True or False: OTC insulin products are not required to have tamper-evident packaging.
False
True or False: Manufacturers are not allowed to capitalize on OTC products.
Dulcolax Stool Softener
Which of the following contain(s) docusate sodium: Dulcolax Stool Softener, Dulcolax tablets, or Dulcolax Milk of Magnesia.
FTC
Who regulates OTC product advertising for print or broadcast?
FDA
Who regulates Rx product advertising for print or broadcast?
False (FDA)
True or False: The FTC regulates OTC product claims on packaging.
Manufacturer, Packer or Distributor
The Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006 mandates who to report serious OTC adverse events?
Manufacturer
Who is responsible for notifying sellers (ie., pharmacists) of OTC product recalls?
False
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.
Class III
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?
Class I
What classification of OTC product recall is defined by a dangerous or defective product that predictably could cause serious health problems or death?