ON MAY 28, 2013, THE FOOD and Drug Administration (FDA) published a draft guidance entitled “Contract Manufacturing Arrangements for Drugs: Quality Agreements.” 1 The draft guidance describes FDA’s views on defining, establishing and documenting the responsibilities of parties that are involved in the contract manufacturing of drugs that are subject to current good manufacturing practices (cGMPs). In the draft guidance, FDA recommends that such parties — referred to as “Owners” and “Contracted Facilities” — utilize quality agreements to assure drug quality, safety and efficacy. FDA is expected to finalize the guidance laterthis year. 2

Background

Companies are responsible for ensuring that the drugs they introduce into interstate commerce are not adulterated or misbranded as a result of the acts or omissions of their selected contract manufacturing organizations (CMOs). 3 Similarly, CMOs must assure compliance with cGMPs for all manufacturing, testing or other support operations they undertake.4 In the draft guidance, FDA emphasizes that because the agency “considers contractors an‘extensionofthemanufacturer’s own facility,’ both Owners and Contracted Facilities are responsible for ensuring that their products are not adulterated or misbranded."5

The mutualresponsibility of drug companies and CMOs to assure drug quality arises initially from the new drug application (NDA) process. Among other things, an NDA for a new drug must include “a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packaging of such drug.” 6 This means that an NDA must include “the name and address of each manufacturer of the drug product,” including “each contract facility involved in the manufacture, processing, packaging, ortesting of the drug product and identification of the operation performed by each contract facility.” 7 NDA approval is premised in part on FDA’s determination that the “methods to be used in, and the facilities and controls used for, the manufacture, processing, packing, or holding of the drug substance or the drug product . . . comply with the current good manufacturing practice regulations.” 8 To inform this determination, FDAmay conduct a preapproval inspection of any CMO facility where the drug is to be manufactured. 9 After approval, if the CMO does not manufacture the drug in a manner that ensures the drug’s identity, strength, quality and purity, then FDA may withdraw its approval of the NDA. 10