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Regulations last checked for updates: Nov 24, 2024
Title 21 - Food and Drugs last revised: Nov 21, 2024
All Titles
Title 21
Chapter I
Part 4
Subpart A - Subpart A—Current Good Manufacturing Practice Requirements for Combination Products
§ 4.1 - What is the scope of this subpart?
§ 4.2 - How does FDA define key terms and phrases in this subpart?
§ 4.3 - What current good manufacturing practice requirements apply to my combination product?
§ 4.4 - How can I comply with these current good manufacturing practice requirements for a co-packaged or single-entity combination product?
authority:
21 U.S.C. 321
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331
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351
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352
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353
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355
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360
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360
b-360f,
360
h-360j,
360
l,
360
hh-360ss,
360
aaa-360bbb,
371
,
372
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379e
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381
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383
,
394
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42 U.S.C. 216
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262
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263a
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264
,
271
source:
78 FR 4321, Jan. 22, 2013, unless otherwise noted.
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