Orange Book (FDA Approved Drug Products)
The Orange Book is the FDA publication officially titled "Approved Drug Products with Therapeutic Equivalence Evaluations" that lists approved drug products within its scope and therapeutic equivalence evaluations for approved multisource prescription products; substitution also depends on state law and the prescription.
Exam Tip
Orange Book ratings inform substitution; state law and the prescription still apply. A = FDA therapeutic equivalence within the applicable group; B = not currently established. Match numbered AB groups. BC = extended-release; BN = aerosol-nebulizer systems; BP = potential bioequivalence issues.
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 inform product selection, while state law, the prescription, and any applicable restrictions determine whether substitution is permitted.
Therapeutic Equivalence Ratings
| Rating | Meaning | Can Substitute? |
|---|---|---|
| A-rated (e.g., AB, AN, AP) | FDA considers products therapeutically equivalent within the applicable group | Potentially; follow state law and prescription restrictions |
| B-rated (e.g., BN, BP, BS) | FDA does not currently consider the products therapeutically equivalent | Do not assume automatic substitution; consult the pharmacist |
Common A-Ratings
| Code | Drug Type |
|---|---|
| AA | Conventional dosage forms without known or suspected bioequivalence problems |
| AB | Actual or potential bioequivalence issues resolved with adequate evidence; match numbered groups such as AB1/AB2 |
| AN | Solutions and powders for aerosolization in general-use delivery systems |
| AO | Injectable oil solutions |
| AP | Injectable aqueous solutions |
| AT | Topical products |
Common B-Ratings
| Code | Reason |
|---|---|
| BC | Extended-release products lacking adequate equivalence evidence |
| BN | Products in aerosol-nebulizer drug delivery systems |
| BD | Active ingredients/dosage forms with documented bioequivalence problems |
| BP | Active ingredients/dosage forms with potential 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 A ratings establish FDA therapeutic equivalence within the relevant group; they do not override state substitution law or a prescriber restriction. AB1 and AB2 are different groups. The Orange Book is the FDA's reference for generic substitution decisions.
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Therapeutic Equivalence (Orange Book)
Therapeutic equivalence is the FDA determination that approved pharmaceutical equivalents meet its criteria, including bioequivalence, and are expected to have the same clinical effect and safety under labeled conditions. Orange Book A ratings include AB and several other 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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