first edition (1980) of the Orange Book - FDA Law Blog

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products that have been approved" it contains FDA's advice to the public andto the states regarding an important p.1blic health matter. These evaluationsdo not constitute determinations that any products are in violation ofthe act or that any products are preferable to others. As explained in theFederal Register proposal of January 12, 1979 (44 FR 2932, at pp. 2937-2947), these evaluations are based on the application of certain criteria toinformation contained in FDA files to make these nonregulatory evaluations.E. PRECAUTIONS '10 USERS OF THE LIST1. Need for usual professional care and performance in using the List.The evaluations of therapeutic equivalence in this List are scientificand medical evaluations by FDA. Products evaluated as therapeuticallyequivalent can be expected, in the judgment of the FDA, to have equivalenttherapeutic effect and equivalent potential for adverse effects when usedunder the conditioos of labeling. HOIlever, these products may differ inother characteristics such as, for example, taste, color, packaging, expirationtime, and, in sane instances, labeling. If such products are substitutedfor each other, there is a potential for suchproblerns as patientconfusion due to differences in color or shape of tablets, less patientacceptance of certain products because of flavor, better stability of oneproduct over another under adverse conditions of storage, allergic reactionsin rare cases due to a color ing ingredient, as well as differences inp.1rchase price to the patient. An FDA evaluation of therapeutic equivalencein 00 way relieves practitioners of their professional responsibilities inprescribing and dispensing such products with due care and with appropriateinformation to individual patients. In those uncorrmon circumstances wherethe characteristics of a specific product, other than its active ingredient,are important in the therapy of a particular . patient , the physician'sspecification of that product is appropriate. Pharmacists must also befamiliar with the expiratioo times and labeling conditions for storage,particularly for reconstituted products, to assure that patients areproperly advised when one product is substituted for another.2. Only currently marketed prescription drug products are included on theList.The List includes only those prescription drug products that have beenapproved for marketing under sections 505 and 507 of the act, and which arecurrently being marketed. FDA will remove from the List any drug productwhich is no longer being marketed, even though there remains an approvedapplication for that product. Unrnarketed products may periodically appearon the List, hOIlever, until FDA becomes aware of their non-marketed status ..I - 6
Conversely, when FDA becomes aware through the awlication review processthat an awroved drug prodoct is being re-marketed, it will again beincluded on the List.Consistent with our p::>licy to include only currently marketed prescriptiendrug prodocts, approved antibiotic prodocts will be listed only after theinitial batch has been certified for marketing.3. Multisource and single source drug products are included on the List.In constrocting the List, FDA has evaluated for therapeutic equivalenceonly multisource drug prodocts, i.e., those pharmaceutical equivalentsavailable from more than one manufacturer. For all mul tisource products atherapeutic equivalence code is included and, in additien, those prodoctswhich are therapeutically equivalent are highlighted in bold face and underlined.Those prodocts with awroved applicatiens that are single source arealso included on the List for the sake of completeness, but no therapeuticequivalence code is included with such prodocts. The details of these codesand the p::>licies underlying them are discussed in Section F.4. Products on the List are identified by the names of·holders of approvedapplications.The products en the List are identified by the names of the holders ofawroved awlicatiens, rather than by the names of the actual manufacturersthemselves. This is because the awlicatioo holder may have, for example,had its prodoct manufactured by a contract manufacturer and may simply bedistr ibuting the product for which it has obtained awroval. In mostinstances, hCMever, the manufacturer of the prodoct is the awlicationholder.Although the products on the List are identified by the names of theholders of awroved awlicatioos, several circumstances, such as changingcorp::>rate profiles, have made this determination a difficult one. However,based en intensive and continuing document reviews and en concurrencethrough corrmunicatioo with firms, the awlicatioo holder designatioos en theList, in most cases, are correct.As a general rule, the products 00 the List are not identified by thenames of the distributors of those prodocts. FDA does not believe thatthere is a feasible way at this time to maintain an up-to-date and canpletelist linking the prodocts of each awroved awlication holder with thedistributors and relabelers handling those products. Products subject to anawroved application are frequently manufactured for distributors, under thedistr ibutor I s labeling, for marketing by the distributor. Because thesedistributors often shift their source of suWly in the carmercialmarketplace without informing FDA, even if FDA were to attempt to expand theList to link distributors with holders of approved applicatiens, it \'K)uldnot have ready access to the information necessary to do so.I - 7
Page 5: RXD AND DRUG ACMINISTRATIONAPProVED
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PRESCRIPTION DRUG PRODUCTS DEEMED A
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