Chapter 2

• •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

• - CMS (Centers for Medicare and Medicaid Services)
• - FDA (Food and Drug Administration)

CMS previously knon as HCFA (Health Care Financing Administration)

• •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

• - Biologics Evaluation & Research
• - Drug Evaluation and Research
• - Food Safety and Applied Nutrition
• - Veterinary Medicine
• - Devices & Radiological Health

• •Rulemaking (Regulations)
• •Issue guidance documents
• •Incorporate advice from standing advisory committees of outside experts

•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)

• •Labeling
• •Advertising
• •Nature of product

• 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 

DSHEA

vitamin, mineral, herb or other botanical, amino acid, or substance used to supplement the diet by increasing total dietary intake

• 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

was approved as a drug prior to it being marketed as a DS

• Excludes eliminate articles that achieve their purpose through chemical action and metabolism.
• Ex
• pregnancy testing kit 

Topical articles intended for cleansing, beautifying or altering appearance

Sets uniform standards

Official Compendia (USP and HPUS)

• Warning letters
• Seizure of products: take off the products from the pharmacy
• Injunction court order 
• Criminal action

• - 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

• •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 

- 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

• 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)

• •Required in labeling when use of a drug may lead to death or serious injury.
• •Required for about 450 prescription drugs

• - 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”

• •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.

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.

• Addition of new substance
• New combination of approved drugs
• Change in proportion of ingredients
• New intended use
• Dosage, method, or duration of administration or application is changed