§316.36. Insufficient quantities of orphan drugs. — Inbound Citations
21 C.F.R. § 316.36
Statutory Authority
Cited by 1 regulation in release Current.
Citations to 21 C.F.R. § 316.36 as a whole
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(4) Failure of the holder of exclusive approval to assure a sufficient quantity of the drug under section 527 of the act and § 316.36.