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

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