The FDA has proposed measures to ease manufacturers' regulatory burden concerning constituent materials used in biologics. The rule would grant additional leeway to the biologics and drug center directors to approve "exceptions or alternatives" to current requirements.
The regulator cites advances in developing and manufacturing "safe, pure and potent biological products." The advances, in some cases, render "too prescriptive and unnecessarily restrictive" the existing regulations for such constituents as preservatives, diluents, adjuvants, extraneous protein and antibiotics.
One example: devices that ensure aseptic withdrawal of the biologic. Such devices offer an alternative to the use of preservatives in multiple-dose containers, according to the regulator. "Providing the option to manufacture vaccine in multiple-dose containers without use of a preservative would be acceptable, provided that appropriate safeguards, such as adequate storage, aseptic withdrawing techniques and timely use of the product are followed."
Comments to the proposal are due by late June.
- see the proposed rule