DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
March 31, 2010
CFR Citation: 21 CFR Part 610
Docket ID: [Docket No. FDA-2010-N-0099]
RIN ID: RIN 0910-AG15
NOTICE: PROPOSED RULES
DOCUMENT ACTION: Proposed rule.
The Food and Drug Administration (FDA) is proposing to amend the biologics regulations to permit the Director of the Center for Biologics Evaluation and Research (CBER) or the Director of the Center for Drug Evaluation and Research (CDER), as appropriate, to approve exceptions or alternatives to the regulation for constituent materials. FDA is taking this action due to advances in developing and manufacturing safe, pure, and potent biological products licensed under a section of the Public Health Service Act (the PHS Act) that, in some instances, render the existing constituent materials regulation too prescriptive and unnecessarily restrictive. This rule provides manufacturers of licensed biological products with flexibility, as appropriate, to employ advances in science and technology as they become available, without diminishing public health protections.
Constituent materials regulated under Sec. 610.15 (21 CFR 610.15) include ingredients, preservatives, diluents, adjuvants, extraneous protein and antibiotics that are contained in a biological product. FDA is proposing to amend the regulation for constituent materials at Sec. 610.15 to allow the Director of CBER or the Director of CDER, as appropriate, to approve an exception or alternative to the requirements under Sec. 610.15, when data submitted with the exception or alternative establish the safety, purity, and potency of the biological product. This proposed rule provides manufacturers of biological products with flexibility, as appropriate, to employ advances in science and technology as they become available, without diminishing public health protections. Examples of how the proposed rule would provide flexibility to manufacturers in the use of preservatives and aluminum in biological products are provided below. However, the proposed rule would also provide flexibility to the existing requirements regarding extraneous protein and antibiotics (Sec. 610.15(b) and (c)), provided that each request for an alternative or exception to these requirements is submitted with data that establish the safety, purity, and potency of the biological product.
Standards for certain constituent materials present in biological products are provided under Sec. 610.15. Section 610.15(a) requires that all ingredients used in a licensed product, and any diluent provided as an aid in the administration of the product, meet generally accepted standards of purity and quality. Any preservative used shall be sufficiently nontoxic so that the amount present in the recommended dose of the product will not be toxic to the recipient, and in the combination used it shall not denature the specific substances in the product to result in a decrease below the minimum acceptable potency within the dating period when stored at the recommended temperature. Products in multipledose containers shall contain a preservative, except that a preservative need not be added to Yellow Fever Vaccine; Poliovirus Vaccine Live Oral; viral vaccines labeled for use with the jet injector; dried vaccines when the accompanying diluent contains a preservative; or to an Allergenic Product in 50 percent or more volume in volume glycerin. An adjuvant shall not be introduced into a product unless there is satisfactory evidence that it does not affect adversely the safety or potency of the product.
These regulations also require that the amount of aluminum in the recommended individual dose of a biological product not exceed the following: