21 C.F.R. § 4.1
What is the scope of this subpart?
This subpart applies to combination products. It establishes which current good manufacturing practice requirements apply to these products. This subpart clarifies the application of current good manufacturing practice regulations to combination products, and provides a regulatory framework for designing and implementing the current good manufacturing practice operating system at facilities that manufacture co-packaged or single-entity combination products.
Notes of Decisions
Cited in 3
cases, 1975–1997 · leading case: Johnnie Louis McAlpine v. United States of Am. & Bureau of Indian Affairs, 112 F.3d 1429 (10th Cir. 1997).
Johnnie Louis McAlpine v. United States of Am. & Bureau of Indian Affairs, 112 F.3d 1429 (10th Cir. 1997). “On appeal of the Area Director’s decision to the Secretary of the Interior, the Interior Board of Indian Appeals (IBIA) — to which the Secretary’s authority is delegated, *1431 see 21 C.F.R. § 4.1 (1990) 2 — affirmed, concluding that the administrative record demonstrated that…”
Apicella v. McNeil Labs., Inc., 66 F.R.D. 78 (E.D.N.Y 1975). “45 CFR § 5 and 21 CFR § 4.1 . See also Pub.L. 93-502, 88 Stat.”
McAlpine v. United States (10th Cir. 1997). “On appeal of the Area Director’s decision to the Secretary of the Interior, the Interior Board of Indian Appeals (IBIA)--to which the Secretary’s authority is delegated, see 21 C.F.R. § 4.1 (1990)2--affirmed, concluding that the administrative record demonstrated that the BIA…”
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