Notes on Laws & Requirements - Definitions / References

Question 1

Red Book

Answer 1

Drug Pricing

Question 2

Orange Book

Answer 2

Therapeutic Equivalence (TE)

TE Codes:
* A: TE
* AB: TE [Actual or potential bioequivalence (BE) issues resolved w/ adequate medical evidence (in vivo/vitro)]
* AA, AN, AO, AP, or AT: No in vivo BE issue known/suspected. Designation depends on dosage form.
* B: Not TE
* BC, BD, BE, BN, BP, BR, BS, BT, BX, or B: Actual or potential BE issues NOT resolved w/ adequate medical evidence (in vivo/vitro). Problem is more likely to be with specific dosage forms rather than active ingredients.
* NR: Not Rated (no FDA-approved generic equivalents)
* NA: Not Applicable (Pre-1938 Rx’s & Vitamins/Supplements)
* Off Market: Approved FDA-drugs that have been discontinued or never marketed.

Question 3

Yellow Book

Answer 3

International Travel Vaccines

Question 4

Green Book

Answer 4

FDA-Approved Animal Drug Products

Question 5

Pink Book

Answer 5

Epidemiology & Vaccine-Preventable Diseases
(Has Most Vaccine Information Besides Travel. Travel = Yellow.)

Question 6

Purple Book

Answer 6

Biologic Products: Biosimilarity & Interchangability

• What is A Reference Product?: single FDA-approved biological product vs. proposed biosimilar comparison
• What is A Biosimilar Product?: A biosimilar is a highly similar biologic w/ no meaningful clinical differences from existing FDA-approved reference product.
• What is An Interchangeable Product?: Means that the reference medicine can be replaced by biosimilar without changes in clinical effect. Impacts ease of access, same clinical benefit without extra side effects or safety concerns.
• Conventional Drug: Structure Known (Chemically Sythesized)
• Biologic Drug: Not Easily Identified or Characterized Complex Mixtures (Microorganism, Plant-Cell, Animal-Cell, Small Molecule, etc. Derived Drug via Biotechnology). Used to Diagnose, Prevent, Treat, & Cure Diseases.
• Biologic Drug Examples: Vaccines (Influenza, Tetanus) & Monoclonal Antibodies (adalimumab for RA)

Question 7

USP 795

Answer 7

Nonsterile Compounding

Question 8

USP 797

Answer 8

Sterile Compounding

Question 9

USP 800

Answer 9

Hazardous Drug Handling