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Contract Sourcing facility or organization. The rewards thus seem identical to the solution. IS A HIGHER STANDARD ON THE HORIZON? Make no mistake, however — for many suppliers, low cost is their main or only selling point. Any technology that increases production costs or capital outlays pinches precious margins. To some extent, the entire existence of the generics industry depends on low-cost production and supply. But it doesn't necessarily follow that poor-quality injectables must be the norm. If suppliers that cannot manage to maintain sterility of facilities, equipment, and product drop out of the game, a higher standard will apply to all the players that remain. Prices and margins will adjust accordingly. CHANGE MAY NOT COME SOON ENOUGH Raising the bar for parenteral suppliers may come about without government pressure, but I doubt it. Yes, there is plenty of market pressure, but perhaps a bit too much on both sides of the issue. The recalls and drug shortages that make the news push producers toward the light of a higher standard; the economics toward the dark shadows of cut-rate production. 50 LifeScienceLeader.com April 2013 An echo exists in the question as well — the now age-old struggle between the innovative and the follow-on sides of the industry. Innovation may impel a more progressive approach to new technologies, on the assumption that generics inherently promote the opposite. But ours is a cut-and-paste industry; there are no longer only two distinct camps working in opposition. These days you see Big Pharmas with generics divisions, specialty pharma, new drug-delivery approaches, prospective biosimilars, and every shade in between — all arguably favoring widespread adoption of technologies that ensure purity of parenterals. If you doubt my argument, or indeed accept it, a reliable test for it exists: time. Time will speak the final word on whether suppliers move widely to raise the standards for parenterals, spending what is necessary for prefill and other technologies to ensure sterility and supply from production to point of injection. My somewhat educated guess is that the change will not come soon enough or spread widely enough to save a great number of suppliers from a degraded fate. To the extent such a fallout occurs, we all stand the chance of suffering the consequences, as professionals or as patients.