Herbs/supplements Flashcards Preview

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Flashcards in Herbs/supplements Deck (12)
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1
Q

Regulation that mandates safety of medications

A

Federal Food, Drug and Cosmetic Act

2
Q

Amendment to FDC act that established prescription vs non-prescription medications

A

Durham-Humphrey Amendment

3
Q

Amendment to FDC act that mandated efficacy as well as safety and resulted in the OTC drug review process

A

Kafauver-Harris Amendment

4
Q

Group that is responsible for OTC oversite

A

FDA and code of federal regulations

5
Q

5 labeling criteria for dietary supplements based on Dietary Supplement Health and Education Act (DSHEA)

A
  1. body structure and function claims
  2. cannot make therapeutic claims
  3. must state not approved by FDA
  4. must have manufacturers name and address
  5. not required to have lot #, expiration date, or CIs
6
Q

Amendment to FDC act that requires manufacturers to report serious AEs for OTC drugs and dietary supplements within 15 business days of receipt and have address and phone # on labels

A

Dietary Supplement and Nonprescription Drug Consumer Act (Adverse Event Reports Bill)

7
Q

Active constituents of Fish oils

A

EPA and DHA

8
Q

1st FDA approved omega-3 FA containing EPA and DHA that is indicated as adjunct treatment to diet for hypertriglyceridemia

A

Lovaza

9
Q

FDA approved omega-3 FA that contains only EPA that is indicated as adjunct treatment to diet for hypertriglyceridemia

A

Vascepa

10
Q

1st omega-3 in free FA form (EPA + DHA) that is marketed as easier to absorb on low fat diet

A

Epanova

11
Q

Active component of milk thistle

A

silymarin

12
Q

7 qualities of symptoms to ask about in self-care

A

location, quality, severity, timing, setting, remitting/exacerbating factors, associated symptoms