With the recent NECC meningitis tragedy, Congress as well as every state board of pharmacy is taking a hard look at how compounding pharmacy is regulated. Even though compounding has and will always be part of traditional pharmacy, it has become apparent that the NECC as well as similar “compounding pharmacies” are pushing the boundaries of vague legal descriptions, usually limited to a few sentences in each state’s pharmacy rule and regulations.
However, it’s hard to create new regulations for a specialty that’s so broad and vague. Before any new regulation is considered, we must first define compounding with great detail to make sure we’re all talking about the same thing. It’s apparent that most state boards of pharmacy have no idea who compounds, what they compound, and how much they compound (see the last two Compound News for more information). However, should they? If it’s part of our practice and not currently regulated differently, why would they?
So, what is compounding? What “types” of compounding will be affected by the new regulations. If I mix a few antibiotics and creams each week, am I a compounding pharmacy?
A few questions that need to be answered:
- Is there a difference between a sterile compounding pharmacy and a non-sterile compounding pharmacy? If so, are they regulated differently?
- Is a compounding pharmacy that ships thousands of “prescriptions” each month out of state a pharmacy or small drug manufacturer?
- Is there a % of sales cutoff for compounded prescriptions that determines if you are a compounding pharmacy?
- Is there a number cutoff for one particular compounded medication that determines if you are a drug manufacturer?
- Is a compounding-only pharmacy a pharmacy or small drug manufacturer? Should there be a new classification?
Source found here
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