Examples of Combination Products in a sentence
Combination Products may also be subject to UDI requirements (see 21 CFR 801.30).
The obligations set forth in Sections 3.1, 3.2 and 3.3 with respect to Licensee’s supply of API shall not apply to active pharmaceutical ingredients other than API that Licensee may incorporate into Combination Products.
If the device or combination product has been modified or the indications for use have been modified since the RFD, the RFD determination may no longer be applicable and jurisdiction may need to be reevaluated by the Office of Combination Products (OCP).
The Office of Combination Products (Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
See Drug Enforcement Administration, “Schedules of Controlled Substances: Rescheduling of Hydrocodone Combination Products From Schedule III to Schedule II,” 79 FR 49661 (August 22, 2014).