Self Care Legal and Regulatory Issues
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36 terms
Terms | Definitions |
|---|---|
 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? |
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