Code of Federal Regulations: Containing a Codification of Documents of General Applicability and Future Effect as of December 31, 1948, with Ancillaries and IndexDivision of the Federal Register, the National Archives, 1998 Special edition of the Federal Register, containing a codification of documents of general applicability and future effect ... with ancillaries. |
No grāmatas satura
6.–10. rezultāts no 100.
332. lappuse
... batch shall submit with his request the following information and samples : ( 1 ) The batch mark of the drug . ( 2 ) The quantity of each ingredient used in making the batch and a state- ment that each such ingredient con- forms to the ...
... batch shall submit with his request the following information and samples : ( 1 ) The batch mark of the drug . ( 2 ) The quantity of each ingredient used in making the batch and a state- ment that each such ingredient con- forms to the ...
333. lappuse
... batch . ( 11 ) If such batch or any part thereof is to be packaged with a sterile diluent or sterile dispenser , such request shall also be accompanied by a statement that such diluent or dispenser is sterile and conforms to the ...
... batch . ( 11 ) If such batch or any part thereof is to be packaged with a sterile diluent or sterile dispenser , such request shall also be accompanied by a statement that such diluent or dispenser is sterile and conforms to the ...
335. lappuse
... batch so included is re- quested , such certificate shall continue to be effective for a reasonable time to permit certification of such batch which is part of such combination ; ( 4 ) With respect to any package when the drug therein ...
... batch so included is re- quested , such certificate shall continue to be effective for a reasonable time to permit certification of such batch which is part of such combination ; ( 4 ) With respect to any package when the drug therein ...
342. lappuse
... batch certifi- cation requirements . ( a ) If at any time an exemption from batch certification requirements for an antibiotic drug for human use has been granted , the Commissioner finds on the basis of new information before the ...
... batch certifi- cation requirements . ( a ) If at any time an exemption from batch certification requirements for an antibiotic drug for human use has been granted , the Commissioner finds on the basis of new information before the ...
343. lappuse
... batch from which any shipment or delivery is made to such establishment unless it is exempt under section 801 ( d ) of the act or § 433.17 ; that he will not remove any of such antibiotic drug from such estab- lishment unless it ...
... batch from which any shipment or delivery is made to such establishment unless it is exempt under section 801 ( d ) of the act or § 433.17 ; that he will not remove any of such antibiotic drug from such estab- lishment unless it ...
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abbre abbreviated application abbreviated new drug acid active ingredient adverse drug experience agency amended antibiotic application or abbreviated bacitracin bioavailability bioequivalence cation Center for Drug certification chapter clinical hold clinical investigation conducted control number copy Cosmetic Act digoxin dosage form dose Drug Administration drug application Drug Evaluation drug prod drug product Drug products containing drug substance Evaluation and Research Federal Food Food and Drug graph gredients hearing hydrochloride identified information requirements ap insulin intended inves investigational new drug labeling manufacturer marketing meet ment milligrams milliliters misbranded neomycin notice oral dosage orphan drug OTC drug product package paragraph percent person plication polymyxin proposed protocol recognized as safe reference listed drug request safe and effective safety section 502 Sodium sponsor statement submission Subpart sulfate tained tigational tion tive treatment treatment IND vestigational viated warning