Chapter 2

  1. Reasons for fedral drug regulation
    • •Protection of the public against adulterated and misbranded drug products
    • aldulterated: adding inferior ingredients
    • •Necessity of balancing “direct regulation” and “indirect regulation”

    • - Direct regulation: keep off drugs that did not met government safety standard
    • - Indirect regulation: labels

  2. What is  housed under DHHS?
    • - CMS (Centers for Medicare and Medicaid Services)
    • - FDA (Food and Drug Administration)

    CMS previously knon as HCFA (Health Care Financing Administration)
  3. Federal Food And Drug Administration (FDA)
    •Housed under the.................
    •Authority for administering the...........
    •FDA secretary appointed by.......with confirmation of.......
    • •Housed under the Department of Health & Human Services (DHHS)
    • •Authority for administering the FDCA Food, Drug and Cosmetic ACT
    • •FDA secretary appointed by President with confirmation of Senate
  4. Structure of FDA
    • - Biologics Evaluation & Research
    • - Drug Evaluation and Research
    • - Food Safety and Applied Nutrition
    • - Veterinary Medicine
    • - Devices & Radiological Health
  5. Functions of FDA
    • •Rulemaking (Regulations)
    • •Issue guidance documents
    • •Incorporate advice from standing advisory committees of outside experts
  6. What is a Drug?
    Articles intended for use in diagnosis, cure, mitigation, treatment or prevention of disease (Part B)

    Articles other than food intended to affect the structure or function of the body (Part C)

  7. Evidence A Product is a Drug
    • •Labeling
    • •Advertising
    • •Nature of product
  8. Food Categories
    • 1 •Legal categories created by FDCA
    • –Special dietary foods, 
    •          food for pregnancy, infancy, hypertension,   overweight, underweight, control the
    • intake of sodium
    • –Medical foods, 
    •             food formulated without the amino acid phenylalanine for phenylketonuria

    • 2•Publicly conceived categories
    • –Nutraceuticals & functional foods
    • –Nutraceuticals provide health or medical benefits 
  9. .................created a new special category of
    food called “dietary supplements” (DSs)
  10. Definition of DS (Dietary Supplement)?
    vitamin, mineral, herb or other botanical, amino acid, or substance used to supplement the diet by increasing total dietary intake
  11. DSHEA only permits DS manufacturers to make health claims if
    What is the exception
    • 1-  FDA approves the claim by regulation or by
    • 2- Significant scientific agreement test.

    Pearson v. Shalala, however, held that DS manufacturers could make health claims not approved by the FDA provided they are not false or misleading and accompanied by a disclaimer
  12. DSHEA excludes an article as a DS if it 
    was approved as a drug prior to it being marketed as a DS
  13. Definition of device
    • Excludes eliminate articles that achieve their purpose through chemical action and metabolism.
    • Ex
    • pregnancy testing kit 
  14. Definition of cosmetic 
    Topical articles intended for cleansing, beautifying or altering appearance
  15. USP
    Sets uniform standards

    Official Compendia (USP and HPUS)
  16. FDA Enforcement Authority
    • Warning letters
    • Seizure of products: take off the products from the pharmacy
    • Injunction court order 
    • Criminal action
  17. Three classes of recalls
    • - Class I recalls: product will cause SERIOUS adverse health consequences or death
    • - Class II recalls: product will cause TEMPORAR or medically reversible adverse health consequences
    • - Class III recalls: product will not likely to cause adverse health consequences
  18. •Adulteration provisions focus on both................
    • •Adulteration provisions focus on both the facility and the product. 
    • •Drug is adulterated if its strength, quality, or purity differs from compendia standards unless plainly stated on label

    •Drug is adulterated if its strength, quality, or purity differs from label 
  19. Misbranding
    - Labeling must not be false or misleading 

    • •Labeling must include
    • 1- listing of active ingredients and quantity and listing of inactive ingredients in alpha order
    • 2-  “adequate directions for use” and
    • 3- “adequate warnings against use” by children and others for whom use might be dangerous

    If drug cannot be labeled with “adequate directions for use”, it must contain “adequate information for use”

    •It is misbranding if a drug imitates mimics another drug
  20. What is the format for non prescription Drug Labeling?
    • User friendly format including
    • - pharmacological category or principal intended use,
    • - cautions
    • - warnings, adequate directions for use
    • - “Drug Facts” panel (Active ingredient- Purpose- Use- Warnings- Directions- other information- Inactive ingredient- Questions)
  21. Black Box Warnings
    • •Required in labeling when use of a drug may lead to death or serious injury.
    • •Required for about 450 prescription drugs
  22. Five catogories of risk in pregnancy 
    • - Category A: well-controlled studies in pregnant women- have not demonstrated a risk to the fetus “only if clearly needs”
    • - Category B: Animal studies have failed to demonstrate a risk to the fetus- the are no we controlled studies in pregnant women- “only if clearly needed”
    • Category C: Either animal studied have shown an adverse effect on the fetus- “only if the potential benefit justifies
    • the potential risk to the fetus”
    • Category D: Positive evidence of fetal risk

    Category X: Studied on animals or humans have demonstrated fetal risk, and that risk in pregnant women clearly outweighs any benefits- “may cause fetal harm when administrated to a pregnant women”
  23. National Drug Code Number NDC
    • •11-digit three segment code
    • (00000-0000-00)

    • •The first segment identifies manufacturer or distributor,
    • the second segment identifies the drug (strength, dosage for and formulation 
    • the third segmant identifies package size and type of drug.
  24. Defenition of New Drug
    Drug that is not generally recognized by qualified experts as safe and effective (GRASE) for use under the conditions recommended in the drug’s labeling; and, have been used for a material extent and time for conditions recommended in labeling.
  25. An approved drug can become a new drug under certain conditions
    • Addition of new substance
    • New combination of approved drugs
    • Change in proportion of ingredients
    • New intended use
    • Dosagemethod, or duration of administration or application is changed
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Chapter 2
Chapter 2