As to the first part, it depends on your state law. PA require that the products be A rated.
AA Products in conventional dosage forms not presenting bioequivalence problems
Products coded as
AA contain active ingredients and dosage forms that are not regarded as presenting either actual or potential bioequivalence problems or drug quality or standards issues. However, all oral dosage forms must, nonetheless, meet an appropriate
in vitro bioequivalence standard that is acceptable to the Agency in order to be approved.
AB, AB1, AB2, AB3... Products meeting necessary bioequivalence requirements
Multisource drug products listed under the same heading (i.e., identical active ingredients(s), dosage form, and route(s) of administration) and having the same strength (see
Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded
AB if a study is submitted demonstrating bioequivalence.
In certain instances, a number is added to the end of the
AB code to make a three character code (i.e.,
AB1, AB2, AB3, etc.). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against. For example, Adalat® CC (Miles) and Procardia XL® (Pfizer), extended-release tablets, are listed under the active ingredient nifedipine. These drug products, listed under the same heading, are not bioequivalent to each other. Generic drug products deemed by FDA to be bioequivalent to Adalat® CC and Procardia XL® have been approved, Adalat® CC and Procardia XL® have been assigned ratings of
AB1 and
AB2, respectively. The generic drug products bioequivalent to Adalat® CC would be assigned a rating of
AB1 and those bioequivalent to Procardia XL® would be assigned a rating of
AB2. (The assignment of an
AB1 or
AB2 rating to a specific product does not imply product preference.) Even though drug products of distributors and/or repackagers are not included in the List, they are considered therapeutically equivalent to the application holder's drug product if the application holder's drug product is rated either with an
AB or three-character code or is single source in the List. Drugs coded as
AB under a heading are considered therapeutically equivalent only to other drugs coded as
AB under that heading. Drugs coded with a three-character code under a heading are considered therapeutically equivalent only to other drugs coded with the same three-character code under that heading.
AN Solutions and powders for aerosolization
Uncertainty regarding the therapeutic equivalence of aerosolized products arises primarily because of differences in the drug delivery system. Solutions and powders intended for aerosolization that are marketed for use in any of several delivery systems are considered to be pharmaceutically and therapeutically equivalent and are coded
AN. Those products that are compatible only with a specific delivery system or those products that are packaged in and with a specific delivery system are coded
BN, unless they have met an appropriate bioequivalence standard. Solutions or suspensions in a specific delivery system will be coded
AN if the bioequivalence standard is based upon
in vitro methodology, if bioequivalence needs to be demonstrated by
in vivo methodology then the drug products will be coded
AB.
AO Injectable oil solutions
The absorption of drugs in injectable (parenteral) oil solutions may vary substantially with the type of oil employed as a vehicle and the concentration of the active ingredient. Injectable oil solutions are therefore considered to be pharmaceutically and therapeutically equivalent only when the active ingredient, its concentration, and the type of oil used as a vehicle are all identical.
AP Injectable aqueous solutions and, in certain instances, intravenous non-aqueous solutions
It should be noted that even though injectable (parenteral) products under a specific listing may be evaluated as therapeutically equivalent, there may be important differences among the products in the general category,
Injectable; Injection. For example, some injectable products that are rated therapeutically equivalent are labeled for different routes of administration. In addition, some products evaluated as therapeutically equivalent may have different preservatives or no preservatives at all. Injectable products available as dry powders for reconstitution, concentrated sterile solutions for dilution, or sterile solutions ready for injection are pharmaceutical alternative drug products. They are not rated as therapeutically equivalent (AP) to each other even if these pharmaceutical alternative drug products are designed to produce the same concentration prior to injection and are similarly labeled. Consistent with accepted professional practice, it is the responsibility of the prescriber, dispenser, or individual administering the product to be familiar with a product's labeling to assure that it is given only by the route(s) of administration stated in the labeling.
Certain commonly used large volume intravenous products in glass containers are not included on the List (e.g., dextrose injection 5%, dextrose injection 10%, sodium chloride injection 0.9%) since these products are on the market without FDA approval and the FDA has not published conditions for marketing such parenteral products under approved NDAs. When packaged in plastic containers, however, FDA regulations require approved applications prior to marketing. Approval then depends on, among other things, the extent of the available safety data involving the specific plastic component of the product. All large volume parenteral products are manufactured under similar standards, regardless of whether they are packaged in glass or plastic. Thus, FDA has no reason to believe that the packaging container of large volume parenteral drug products that are pharmaceutically equivalent would have any effect on their therapeutic equivalence.
The strength of parenteral drugs products is defined as the total drug content of the container. Until recently the strength of liquid parenteral drug products in the Orange Book have not been displayed. The concentration of the liquid parenteral drug product in the Orange Book has been shown as xmg/ml. The amount of dry powder or freeze dried powder in a container has always been identified as the strength.
With the finalization of the Waxman-Hatch amendments that characterized each strength of a drug product as a listed drug it became evident that the format of the Orange Book should be changed to reflect each strength of a parenteral solution. To this end the OGD has started to display the strength of all new approvals of parenteral solutions. Previously we would have displayed only the concentration of an approved parenteral solution, e.g. 50mg/ml. If this drug product had a 20 ml and 60 ml container approved the two products would be shown as 1Gm / 20ml (50mg/ml) and 3Gm / 60ml (50mg/ml).
AT Topical products
There are a variety of topical dosage forms available for dermatologic, ophthalmic, otic, rectal, and vaginal administration, including creams, gels, lotions, oils, ointments, pastes, solutions, sprays and suppositories. Even though different topical dosage forms may contain the same active ingredient and potency, these dosage forms are not considered pharmaceutically equivalent. Therefore, they are not considered therapeutically equivalent. All solutions and DESI drug products containing the same active ingredient in the same topical dosage form for which a waiver of
in vivo bioequivalence has been granted and for which chemistry and manufacturing processes are adequate to demonstrate bioequivalence, are considered therapeutically equivalent and coded
AT. Pharmaceutically equivalent topical products that raise questions of bioequivalence, including all post-1962 non-solution topical drug products, are coded
AB when supported by adequate bioequivalence data, and
BT in the absence of such data.
Drugs not considered equivalent are B rated:
"B" CODES
Drug products that FDA, at this time, considers not to be therapeutically equivalent to other pharmaceutically equivalent products.
"
B" products, for which actual or potential bioequivalence problems have not been resolved by adequate evidence of bioequivalence, often have a problem with specific dosage forms rather than with the active ingredients. Drug products designated with a "
B" code fall under one of three main policies:
(1) the drug products contain active ingredients or are manufactured in dosage forms that have been identified by the Agency as having documented bioequivalence problems or a significant potential for such problems and for which no adequate studies demonstrating bioequivalence have been submitted to FDA; or
(2) the quality standards are inadequate or FDA has an insufficient basis to determine therapeutic equivalence; or
(3) the drug products are under regulatory review.
The specific coding definitions and policies for the "
B" sub-codes are as follows:
B* Drug products requiring further FDA investigation and review to determine therapeutic equivalence
The code
B* is assigned to products previously assigned an
A or
B code when FDA receives new information that raises a significant question regarding therapeutic equivalence that can be resolved only through further Agency investigation and/or review of data and information submitted by the applicant. The
B* code signifies that the Agency will take no position regarding the therapeutic equivalence of the product until the Agency completes its investigation and review.
BC Extended-release dosage forms (capsules, injectables and tablets)
Extended-release tablets are formulated in such a manner as to make the contained medicament available over an extended period of time following ingestion.
Although bioavailability studies have been conducted on these dosage forms, they may be subject to bioavailability differences, primarily because firms developing extended-release products for the same active ingredient rarely employ the same formulation approach. FDA, therefore, does not consider different extended-release dosage forms containing the same active ingredient in equal strength to be therapeutically equivalent unless equivalence between individual products in both rate and extent has been specifically demonstrated through appropriate bioequivalence studies. Extended-release products for which such bioequivalence data have not been submitted are coded
BC, while those for which such data are available have been coded
AB.
BD Active ingredients and dosage forms with documented bioequivalence problems
The
BD code denotes products containing active ingredients with known bioequivalence problems and for which adequate studies have not been submitted to FDA demonstrating bioequivalence. Where studies showing bioequivalence have been submitted, the product has been coded
AB.
BE Delayed-release oral dosage forms
Where the drug may be destroyed or inactivated by the gastric juice or where it may irritate the gastric mucosa, the use of “enteric” coatings is indicated. Such coatings are intended to delay the release of the medication until the tablet has passed through the stomach. Drug products in delayed-release dosage forms containing the same active ingredients are subject to significant differences in absorption. Unless otherwise specifically noted, the Agency considers different delayed-release products containing the same active ingredients as presenting a potential bioequivalence problem and codes these products
BE in the absence of
in vivo studies showing bioequivalence. If adequate
in vivo studies have demonstrated the bioequivalence of specific delayed-release products, such products are coded
AB.
BN Products in aerosol-nebulizer drug delivery systems
This code applies to drug solutions or powders that are marketed only as a component of, or as compatible with, a specific drug delivery system. There may, for example, be significant differences in the dose of drug and particle size delivered by different products of this type. Therefore, the Agency does not consider different metered aerosol dosage forms containing the same active ingredient(s) in equal strengths to be therapeutically equivalent unless the drug products meet an appropriate bioequivalence standard, such products are coded
AB.
BP Active ingredients and dosage forms with potential bioequivalence problems
FDA's bioequivalence regulations (21 CFR 320.33) contain criteria and procedures for determining whether a specific active ingredient in a specific dosage form has a potential for causing a bioequivalence problem. It is FDA's policy to consider an ingredient meeting these criteria as having a potential bioequivalence problem even in the absence of positive data demonstrating inequivalence. Pharmaceutically equivalent products containing these ingredients in oral dosage forms are coded
BP until adequate
in vivo bioequivalence data are submitted, such products are coded
AB. Injectable suspensions containing an active ingredient suspended in an aqueous or oleaginous vehicle have also been coded
BP. Injectable suspensions are subject to bioequivalence problems because differences in particle size, polymorphic structure of the suspended active ingredient, or the suspension formulation can significantly affect the rate of release and absorption. FDA does not consider pharmaceutical equivalents of these products bioequivalent without adequate evidence of bioequivalence, such products would be coded
AB.
BR Suppositories or enemas that deliver drugs for systemic absorption
The absorption of active ingredients from suppositories or enemas that are intended to have a systemic effect (as distinct from suppositories administered for local effect) can vary significantly from product to product. Therefore, FDA considers pharmaceutically equivalent systemic suppositories or enemas bioequivalent only if
in vivo evidence of bioequivalence is available. In those cases where
in vivo evidence is available, the product is coded
AB. If such evidence is not available, the products are coded
BR.
BS Products having drug standard deficiencies
If the drug standards for an active ingredient in a particular dosage form are found by FDA to be deficient so as to prevent an FDA evaluation of either pharmaceutical or therapeutic equivalence, all drug products containing that active ingredient in that dosage form are coded
BS. For example, if the standards permit a wide variation in pharmacologically active components of the active ingredient such that pharmaceutical equivalence is in question, all products containing that active ingredient in that dosage form are coded
BS.
BT Topical products with bioequivalence issues
This code applies mainly to post-1962 dermatologic, ophthalmic, otic, rectal, and vaginal products for topical administration, including creams, ointments, gels, lotions, pastes, and sprays, as well as suppositories not intended for systemic drug absorption. Topical products evaluated as having acceptable clinical performance, but that are not bioequivalent to other pharmaceutically equivalent products or that lack sufficient evidence of bioequivalence, will be coded
BT.
BX Drug products for which the data are insufficient to determine therapeutic equivalence
The code
BX is assigned to specific drug products for which the data that have been reviewed by the Agency are insufficient to determine therapeutic equivalence under the policies stated in this document. In these situations, the drug products are presumed to be therapeutically inequivalent until the Agency has determined that there is adequate information to make a full evaluation of therapeutic equivalence.
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm079068.htm#Therapeutic Equivalence Evaluations Codes
Only the Watson/Actavis brand is A rated because it is made by Concerta's manufacturer. All other brands (K-U, Mallincrodt) are NOT equivalent.
Bad app, not updated, don't use it. What else is not up to date?
Depends, usually yes. If the original drug withdraws it's
NDA, the generic goes away with it. If the brand name just ceased manufacture, the generic is still good to go.
Bad app. As to the rest of the question, that's what you will learn in school. Each case is different.
CDC Vaccine Schedule (Updated yearly)
Apps available.
