1.
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?
2.
aNDA: What must a second manufacturer submit if they want to manufacture a drug already approved by the FDA?
3.
Category I: Which category of OTC ingredient is considered to have sufficient evidence of safety and effectiveness?
4.
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?
5.
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?
6.
Dulcolax Stool Softener: Which of the following contain(s) docusate sodium: Dulcolax Stool Softener, Dulcolax tablets, or Dulcolax Milk of Magnesia.
7.
Durham-Humphrey 1951: Which amendment established 2 separate classes of drugs?
8.
False: True or False: Manufacturers can only use certain ingredients with FDA approval when manufacturing a drug.
9.
False: True or False: The FDA can prevent further sale of an OTC drug if it's misbranded, adulterated, or unapproved without court injunction.
10.
False: True or False: Manufacturers are not allowed to capitalize on OTC products.
11.
False: True of False: The OTC Monograph process requires pre-market approval.
12.
False: True or False: A new drug can come to the OTC product only if it is Rx first, then reclassified to nonprescription.
13.
False (FDA): True or False: The FTC regulates OTC product claims on packaging.
14.
False (notifying consumers if necessary): True or False: Pharmacists are not responsible for any part of an OTC product recall.
15.
False (over 80): True or False: Only 40 drugs have switched from Rx to OTC since 1976.
16.
FDA: Who regulates Rx product advertising for print or broadcast?
17.
FDCA 1938: Which act requires all new drugs to have an NDA?
18.
FDCA 1938: Which act mandated safety of OTC drugs?
19.
FTC: Who regulates OTC product advertising for print or broadcast?
20.
Indications, Warnings, Directions for use: What are the three labeling requirements for OTC products?
21.
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?
22.
Manufacturer: Who is responsible for notifying sellers (ie., pharmacists) of OTC product recalls?
23.
Manufacturer, Packer or Distributor: The Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006 mandates who to report serious OTC adverse events?
24.
Manufacturing: What preserves a drug's identity, strength, quality, and purity?
25.
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?
26.
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.
27.
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?
28.
OTC Monograph: What develops a listing of therapeutic OTC classes for GRAS/E ingredients?
29.
sNDA: What does a manufacturer need to submit in order to request an Rx product be switched to OTC?
30.
True: True or False: The OTC Monograph process is a public process.
31.
True: True or False: An approved NDA is manufacturer specific.
32.
True: True or False: The OTC Monograph process does not require actual use studies.
33.
True: True or False: An OTC product lacking the "Drug Facts" box would be considered misbranded.
34.
True: True or False: OTC insulin products are not required to have tamper-evident packaging.
35.
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.
36.
Use: What term is required on OTC Drug Fact Labeling in place of the term "indications"?
