Week 8 Final: NR566 / NR-566
(Latest Update )
Advanced Pharmacology for Care of
the Family | Test Module Questions
& Answers | 100% Correct | Grade
A - Chamberlain
Question:
Laws related to CAM
Dietary Supplement and Nonprescription Drug Consumer Protection Act of
2006
Answer:
mandates the reporting of serious adverse events for nonprescription drugs
and dietary supplements. The following events should be reported: deaths,
hospitalizations, life-threatening experiences, persistent or significant
disabilities, and birth defects. Manufacturers and distributors must report
these to the FDA within 15 days.
, Question:
Laws related to CAM
Current Good Manufacturing Practices (CGMP) ruling of 2007
Answer:
designed to ensure that dietary supplements be devoid of adulterants,
contaminants, and impurities and that package labels accurately reflect the
identity, purity, quality, and strength of what is inside. In addition, the label
should indicate not only active ingredients but also inactive ingredients. The
CGMP also mandates that manufacturers establish quality-control
procedures, with the objective of preventing mislabeled, underfilled, or
overfilled formulations; variations in tablet size, color, or potency; and
contamination with drugs, bacteria, pesticides, glass, lead, and other
potential contaminants.
Question:
Laws related to CAM
Dietary Supplement Health and Education Act (DSHEA) of 1994
Answer:
requires that conventional drugs—both prescription and over-the-counter
agents—undergo rigorous evaluation of safety and efficacy before receiving
FDA approval for marketing.
The DSHEA does impose some restrictions on labeling. All herbal products
must be labeled as dietary supplements. In addition, the label must not claim
that the product can be used to diagnose, prevent, treat, or cure a disease. In
fact, it must state the opposite: this product is not intended to diagnose, treat,
cure, or prevent any disease. However, the label is allowed to make claims
about the product's ability to favorably influence body structure or function.
