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1. Regulatory concepts

2. Orange book: APPROVED DRUG PRODUCTS with THERAPEUTIC EQUIVALENCE EVALUATIONS
identifies drug products approved on the basis of safety and effectiveness by the Food
andDrug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (theFD&C Act).
Orange Book contains therapeutic equivalence evaluations for approved multisource
prescription drug products. These evaluations have been prepared to serve as public
information and advice to state health agencies, prescribers, and pharmacists to promote
public education in the area of drugproduct selection.
The first publication of the Orange Book in October 1980, concurrent with finalization of the
rule, incorporated appropriate revisions. Each subsequent edition has included new approvals
and made appropriate changes in data.

3. The Orange Book is composed of four parts:
(1) approved prescription drug products with therapeutic equivalence evaluations;
(2) approved over-the-counter (OTC) drug products for those drugs that may not be marketed
without NDAs or ANDAs because they are not covered under existing OTC monographs;
(3) drug products with approval under Section 505 of the FD&C Act administered by the Center
for Biologics Evaluation and Research (CBER); and
(4) a cumulative list of approved products that have never been marketed, are for exportation,
are for military use, have been discontinued from marketing

4. Therapeutic Equivalence-Related Terms :
Pharmaceutical Equivalents: Pharmaceutical equivalents are drug products in identical
dosage forms and route(s) of administration that contain identical amounts of the identical
active drug ingredient, i.e., the same salt or ester of the same therapeutic moiety, do not
necessarily contain the same inactive ingredients; and meet the identical compendial or other
applicable standard of identity, strength, quality, and purity, including potency and, where
applicable, content uniformity, disintegration times, and/or dissolution rates.
They may differ in characteristics such as shape, scoring configuration, release
mechanisms, packaging, excipients (including colors, flavors, preservatives),
expirationdate/time, and, within certain limits, labeling.

5. Pharmaceutical Alternatives: Pharmaceutical alternatives are drug products that contain the
identical therapeutic moiety, or its precursor, but not necessarily in the same amount or
dosage form, or the same salt or ester
(e.g., tetracycline hydrochloride, 250mg capsules vs. tetracycline phosphate complex, 250mg
capsules; quinidine sulfate, 200mg tablets vs. quinidine sulfate, 200mg capsules).
Therapeutic Equivalents: Approved drug products are considered to be therapeutic
equivalents if they are pharmaceutical equivalents for which bioequivalence has been
demonstrated, and they can be expected to have the same clinical effect and safety profile
when administered to patients under the conditions specified in the labeling

6. Strength: Strength refers to the amount of drug substance contained in, delivered, or deliverable
from a drug product, which includes: (1)(a) the total quantity of drug substance in mass or units
of activity in a dosageunit or container closure (e.g., weight/unit dose, weight/volume
orweight/weight in a container closure, or units/volume or units/weight in acontainer closure);
and/or, as applicable, (b) the concentration of the drug substance in mass or units of activity per
unit volume or mass (e.g., weight/weight, weight/volume, or units/volume);
Bioavailability.: Bioavailability is the rate and extent to which the active ingredient or active
moiety is absorbed from a drug product and becomes available at the site of drug action.
Bioequivalence: Bioequivalence is the absence of a significant differencein the rate and extent to
which the active ingredient or active moiety inpharmaceutical equivalents or pharmaceutical
alternatives becomes available at the site of drug action when administered at the same molar
dose under similar conditions in an appropriately designed study

7. Section 505(j)(8)(B) of the FD&C Act describes certain conditions under which a test drug and
reference listed drug shall be considered bioequivalent:
I)the rate and extent of absorption of the [test] drug do not show a significant difference from
the rate and extent of absorption of the [reference] listed drug when administered at the same
molar dose of the therapeutic ingredient under similar experimental conditions in either a single
dose or multiple doses; or
(ii)the extent of absorption of the [test] drug does not show a significant difference from the
extent of absorption of the[reference] listed drug when administered at the same molar dose of
the therapeutic ingredient under similar experimental conditions in either a single dose or
multiple doses

8. A" CODES
Drug products that are considered to be therapeutically equivalent to other pharmaceutically
equivalent products
AA Products in conventional dosage forms not presenting bioequivalence problems
AB, AB1, AB2, AB3... Products meeting necessary bioequivalence requirements
AN Solutions and powders for aerosolization
AO Injectable oil solutions
AT Topical products
B" CODES
Drug products that FDA, at this time, considers not to be therapeutically equivalent to other
pharmaceutically equivalent products

9. Drug Product Lists: The Prescription and OTC Drug Product Lists,arranged alphabetically by
active ingredient(s), contain product identification information (active ingredients, dosage
forms, routes of administration, product names, applicants, strengths) for single and
multiple ingredient drug products.
The application number preceded by an “A” is an Abbreviated NewDrug Application (ANDA
or commonly the generic).
Product Name Index: (Prescription and OTC Drug Product Lists). This is an index of drug
products by trade name or established name of the active ingredient, if no trade name exists

10. Federal Register (FR)
Each day Federal agencies publish documents and announcements in the Federal Register (FR),
including:
Final rules and regulations
Proposed rules (including petitions to agencies from the public)
Public notices (such as meetings open to the public, notice of availability of guidance for
industry, and availability of grant applications)
Presidential actions
The Federal Register website is designed to make it easier for citizens and communities to
understand the regulatory process and to participate in government decision-making. The
home page is organized into six major topic sections, similar to a web journal (Money,
Environment, World, Science & Technology, Business & Industry, and Health & Public Welfare)
https://www.federalregister.gov/

11. Code of Federal Regulations (CFR):
The Code of Federal Regulations (CFR) is the codification of the general and permanent rules
that were published in the Federal Register by the departments and agencies of the Federal
Government.
It is divided into 50 subject titles that represent broad topic areas subject to Federal regulation.
Each title of the CFR is updated once each calendar year.
Title 21 of the CFR is reserved for rules of the Food and Drug Administration. It is divided
into chapters and parts such as food for humans, drugs, food & drugs for animals, cosmetics,
medical devices, and tobacco products.

13. Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and
Biosimilarity or Interchangeability Evaluations

14. The Purple Book database contains information on all FDA-licensed (approved) biological
products regulated by the Center for Drug Evaluation and Research (CDER), including licensed
biosimilar and interchangeable products, and their reference products.
The Purple Book also contains information about all FDA-licensed allergenic, cellular and gene
therapy, hematologic, and vaccine products regulated by the Center for Biologics Evaluation
and Research (CBER).
Enter a product's proprietary (brand) name or the nonproprietary (proper) name to find
biological products. As you type, a list of potential results will begin to appear below the
search box based on what you are typing. The results page for your selected product will
include all biological products that share a core name (i.e., biosimilar, interchangeable,
reference, and related biological products).

15. Some of the information you can find in the Purple Book includes:
The date on which a biological product was licensed under section 351(a) or 351(k) of the
Public Health Service Act (PHS Act).
Whether a biological product licensed under section 351(k) of the PHS Act has been
determined by the FDA to be biosimilar to or interchangeable with a reference biological
product (an already-licensed FDA biological product).
The date of expiration of applicable exclusivity for a biological product if FDA has determined
that the biological product is eligible for reference product exclusivity under section
Patent information for certain licensed biological products
The Purple Book database contains information for multiple users (patients, the general public,
healthcare providers, manufacturers, and researchers)