The Code of Federal Regulations of the United States of AmericaU.S. Government Printing Office, 1992 The Code of Federal Regulations is the codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government. |
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1.–5. rezultāts no 100.
33. lappuse
... package inserts for oral contraceptives . ( a ) Requirement for a patient pack- age insert . The safe and effective use of oral contraceptive drug products re- quires that patients be fully informed of the benefits and the risks ...
... package inserts for oral contraceptives . ( a ) Requirement for a patient pack- age insert . The safe and effective use of oral contraceptive drug products re- quires that patients be fully informed of the benefits and the risks ...
49. lappuse
... package insert in or with each package of the drug product that the manufacturer or distributor in- tends to be dispensed to a patient . ( 2 ) In the case of estrogen drug products in bulk packages intended for multiple dispensing , and ...
... package insert in or with each package of the drug product that the manufacturer or distributor in- tends to be dispensed to a patient . ( 2 ) In the case of estrogen drug products in bulk packages intended for multiple dispensing , and ...
51. lappuse
... packages intend- ed for multiple dispensing , a sufficient number of patient - labeling pieces shall be included in or shall accompany each bulk package to assure that one can be included with each package dis- pensed to every patient ...
... packages intend- ed for multiple dispensing , a sufficient number of patient - labeling pieces shall be included in or shall accompany each bulk package to assure that one can be included with each package dis- pensed to every patient ...
237. lappuse
... package , as provided in § 429.45 ( b ) ( 1 ) . ( b ) On the outside container or wrapper of the retail package , the statement " Keep in a cold place , avoid freezing . " ( c ) If the batch contains 40 or 100 U.S.P. Units of insulin ...
... package , as provided in § 429.45 ( b ) ( 1 ) . ( b ) On the outside container or wrapper of the retail package , the statement " Keep in a cold place , avoid freezing . " ( c ) If the batch contains 40 or 100 U.S.P. Units of insulin ...
238. lappuse
... packages , and the labels on the immediate containers of each po- tency of insulin injection shall be dis- tinguished by the following colors : Red , if it contains 40 U.S.P. Units of insu- lin per milliliter . White , if it contains ...
... packages , and the labels on the immediate containers of each po- tency of insulin injection shall be dis- tinguished by the following colors : Red , if it contains 40 U.S.P. Units of insu- lin per milliliter . White , if it contains ...
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300 milligrams accurately weighed acid active ingredients addition to complying agar diffusion assay amdinocillin amended ampicillin azlocillin batch for potency Calculate cefotiam cefpiramide ceftazidime ceftriaxone cefuroxime chapter chromatograph clavulanic acid crystallinity cyclacillin described in paragraph dicloxacillin dilute to volume Dissolve distilled water dosage forms drug product Food and Drug Further dilute gentamicin hetacillin hydrochloride immediate containers injection labeled in accordance less than 90 loss on drying lution master standard means a specific methods of assay-(1 micrograms milligrams milliliter milliliter estimated mobile phase monohydrate nafcillin neomycin neomycin sulfate number of milligrams oxacillin peak penicillin ples polymyxin potassium phosphate preparing the sample Proceed as directed products containing pyrogens reagent represented to contain request shall contain Requests for certification Requirements for certification Results of tests sample solution sodium solu standard solution Standards of identity stock solution Subpart tablets tests and assays Tests and methods tests except sterility ticarcillin tion volumetric flask
Populāri fragmenti
94. lappuse - The responsibility for the human subject must always rest with a medically qualified person and never rest on the subject of the research, even though the subject has given his or her consent.
135. lappuse - As used in this subsection and subsection (e), the term "substantial evidence" means evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibly be, concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended,...
95. lappuse - The refusal of the patient to participate in a study must never interfere with the physician-patient relationship. 5. If the physician considers it essential not to obtain informed consent, the specific reasons for this proposal should be stated in the experimental protocol for transmission to the independent committee (I, 2). 6. The physician can combine medical research with professional care, the objective being the acquisition of new medical knowledge, only to the extent that medical research...
125. lappuse - Secretary when the application was approved, shows that such drug is not shown to be safe for use under the conditions of use upon the basis of which the application was approved...
125. lappuse - ... drug are inadequate to assure and preserve its identity, strength, quality, and purity and were not made adequate within a reasonable time after receipt of written notice from the...
286. lappuse - ... of the act if shipped or sold to, or in the possession of, persons regularly and lawfully engaged in instruction in pharmacy, chemistry, or medicine not involving clinical use; or in law enforcement; or in research not involving clinical use; or in chemical analysis or physical testing, provided they are to be used only for such instruction, law enforcement, research, analysis, or testing, and provided further that their labels bear the statement "Not for drug use.
95. lappuse - In any medical study, every patient — including those of a control group, if any — should be assured of the best proven diagnostic and therapeutic method.
234. lappuse - If offered for use in arthritis or rheumatism, in juxtaposition therewith, the statement: Caution— If pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age, consult a physician immediately.
94. lappuse - Because it is essential that the results of laboratory experiments be applied to human beings to further scientific knowledge and to help suffering humanity...
134. lappuse - A person who requests a hearing may not rely upon allegations or denials but is required to set forth specific facts showing that there is a genuine and substantial issue of fact that requires a hearing with respect to a particular drug product specified in the request for hearing. (i) Where a specific notice of opportunity for hearing (as defined in paragraph (b)(l) of this section) is used, the Commissioner will enter summary judgment against a person who requests a hearing, making findings and...