FDA, USP and CHPA Team Up to Address OTC Drug Impurity Problems

A committee comprised of experts representing FDA, the US Pharmacopeia (USP) and the Consumer Healthcare Products Association (CHPA) is considering how to strengthen the control of impurities in over-the-counter (OTC) products.

Formed over the summer, the new FDA-USP-CHPA committee met for the first time in late September to explore options for tightening the gap between the impurity requirements for OTC-monograph drugs and those approved through NDAs. The options range from creating new regulations and/or guidance to updating USP compendial methods.

Speaking at the Consumer Healthcare Products Association (CHPA) Manufacturing Controls Seminar (MCS) in New Brunswick, NJ in mid-October, CDER Division of Nonprescription Regulation Development Director Scott Furness, who serves on the new committee, noted that an initial two-pronged approach to enhancing the compendia has been suggested in the early discussions.

The first prong would consist of modernization of the individual API and drug product monographs using a risk-based prioritization approach.

The second facet under consideration is the creation of a new USP general chapter that would focus on establishing consistency in critical quality attributes (CQAs) in the same product class – topical, transdermal, solid oral, inhalation, parenterals, etc. – in line with the approach in ICH’s specifications guideline Q6.

Furness pointed to a rewrite of USP General Chapter 3, presented in its Pharmacopeial Forum 36 (6), as indicating where USP may go in this regard. “Think of these new critical quality attribute general chapters as being very analogous to what ICH Q6 said in terms of what the general expectations are.”

A further idea put on the committee’s table was to engage the USP to strengthen its general chapters on impurities (<1086>). The committee generally agreed that a combination of all these approaches may be necessary to comprehensively address the concern.

In his CHPA presentation, Furness provided the broad context for the issues the new committee will be considering. The CDER expert addressed why the issues are important, the implications of the NDA versus monograph regulatory pathways, the related quality/impurity concerns, and the efforts underway to deal with them.

Furness’ assessment of the issues around OTC drug quality is particularly significant because of the roles he plays on various committees that have relevance.

Prior to joining the Office of Nonprescription Drugs in October of 2007, Furness led several initiatives to modernize the OTC monograph system with respect to quality and pharmacokinetics. He served as a chemistry team leader in CDER’s Office of Generic Drugs and vice-chair of CDER’s Drug Substance technical committee, and currently is a member of the CDER working groups on risk-based CMC drug substances, BACPAC II, chiral drugs and polymorphism.

The review official was also one of the primary authors of FDA’s “ANDA Guidance to Industry for Impurities in Drug Substances” (2009).

[Furness’ analysis of the background and future directions for OTC impurity standards and controls is provided for subscribers here.  As a special feature, due to it’s significance, Furness’ full presentation is included in our “Voices from the Dialogue” format.  To subscribe to IPQ, click here.]