Directly Speaking - Where’s the Beef?!
by Scott A. Meyers, Executive Vice President
May 8, 2015
The 1984 Wendy’s slogan has become an American catchphrase. Even though Wendy’s ended its use in 1985 and only revived it briefly in 2011, we frequently hear it used in a variety of situations. Well, today’s “where’s the beef?!” is referring to the suddenly stripped compounding rules in the final draft of the Pharmacy Practice Act Rules revision that went before the Joint Committee on Administrative Rules in mid-April. So where’s the beef? There is no beef or compounding rules at all. No Compounded Sterile Preparation Standards (Section 1330.670) and no Pharmaceutical Compounding Standards (Section 1330.640) that previously existed in the Rules. The almost completely new Pharmaceutical Standards (Section 1330.640) in the first draft of the rules are gone too. This particular new section would have required compliance with all USP compounding related chapters including 795, 797, 81 and more. What’s left? Nothing! Nada! Zip, zero and zilch!
So what happened to them? They were stripped from the draft because of the number of concerns expressed during the comment period last year. The Department staff has assured us that they will return shortly, but time was running out on the rest of the original draft and the Department wanted to codify that which was not contentious now before going back to and refining the Pharmaceutical Compounding Standards.
There’s good news in this seemingly bad news. While some will contend that we could face a few months of the Wild West in compounding in Illinois, the federal standards still apply and perhaps that means that USP 795, 797, etc. are more in effect than ever?! Besides that, we know that the Department staff is already working on the next draft of these important standards taking into account everyone’s concerns with the previous draft and whittling away at most of the contentious language, so the turnaround will be quick.
More importantly, with the rapid response to a seemingly dangerous situation, it gives ICHP a chance to reintroduce new and revised Tech-Check-Tech regulations. If you recall, last year the draft of Tech-Check-Tech regulations ICHP provided to the Department was stripped out because of a last minute objection from IPhA. Their concern centered on the use of this proposed process in the community pharmacy practice setting. So to make sure there is no confusion or last minute dissent, ICHP is working with IPhA to draft language that ensures these rules will apply to the inpatient setting only and only where pharmacists and a clinical pharmacy program are already present.
We will work with IPhA to make sure that the rules are concise and yet provide a base for process verification. We will work with our members to make sure the regulations are workable and valuable and identify all the necessary components for compliance. Tech-Check-Tech is not a new or complicated process. Illinois would not be the first State to implement such a practice. With all the common ground we have fought on with IPhA, this shouldn’t be a difficult task to accomplish.
My hope is that the lack of beef in the compounding standards in the first set of Pharmacy Practice Act Rules will provide extra beef in the next set!
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