Orange Book (FDA Approved Drug Products)
The Orange Book is the FDA publication officially titled "Approved Drug Products with Therapeutic Equivalence Evaluations" that lists all FDA-approved drugs and assigns therapeutic equivalence (TE) ratings to determine which generic drugs can be substituted for brand-name products.
Exam Tip
Orange Book = FDA guide for generic substitution. AB-rated = therapeutically equivalent (CAN substitute). B-rated = NOT equivalent (CANNOT substitute). Most common rating is AB for conventional dosage forms.
What Is the Orange Book?
The Orange Book, officially titled "Approved Drug Products with Therapeutic Equivalence Evaluations," is published by the FDA and is the definitive reference for determining whether generic drugs are therapeutically equivalent to their brand-name counterparts. It is essential for pharmacy practice because TE ratings determine whether a pharmacist can legally substitute a generic for a brand-name drug.
Therapeutic Equivalence Ratings
| Rating | Meaning | Can Substitute? |
|---|---|---|
| A-rated (e.g., AB, AN, AP) | Therapeutically equivalent to reference product | Yes |
| B-rated (e.g., BN, BP, BS) | NOT therapeutically equivalent | No |
Common A-Ratings
| Code | Drug Type |
|---|---|
| AB | Conventional dosage forms (tablets, capsules) - most common |
| AN | Aerosol/nasal products |
| AO | Injectable oil solutions |
| AP | Injectable aqueous solutions |
| AT | Topical products |
Common B-Ratings
| Code | Reason |
|---|---|
| BN | Extended-release products not yet proven equivalent |
| BP | Active ingredients/dosage forms with documented bioequivalence problems |
| BS | Drug products with known deficiencies |
| BX | Insufficient data for equivalence determination |
How the Orange Book Is Used
| User | Application |
|---|---|
| Pharmacists | Determine if generic substitution is appropriate |
| Pharmacy technicians | Identify correct generic alternatives during dispensing |
| Insurance/PBMs | Set formulary and reimbursement policies |
| Manufacturers | Identify opportunities for generic drug development |
Orange Book vs. Purple Book
| Feature | Orange Book | Purple Book |
|---|---|---|
| Covers | Small-molecule drugs | Biological products |
| Equivalence term | Therapeutic equivalence | Biosimilarity/interchangeability |
| Rating system | A/B ratings | Biosimilar/interchangeable designation |
Exam Alert
The Orange Book falls under the Medications domain and Order Entry and Processing domain on the PTCE. Know that AB-rated = can substitute, B-rated = cannot substitute. The Orange Book is the FDA's reference for generic substitution decisions.
Study This Term In
Related Terms
Therapeutic Equivalence (Orange Book)
Therapeutic equivalence is the FDA designation indicating that a generic drug product is both pharmaceutically equivalent and bioequivalent to a reference brand-name drug, as published in the FDA's Orange Book with AB-rated approval codes.
DAW Codes (Dispense As Written)
DAW codes are standardized numeric codes (0-9) used on pharmacy claims to indicate whether a brand-name or generic drug should be dispensed and who is requesting the specific product.
Formulary
A formulary is a list of prescription drugs approved for coverage by a health insurance plan, pharmacy benefit manager (PBM), or healthcare institution, organized into tiers that determine patient cost-sharing.
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