Arizona’s new rules need a little work

The Arizona State Board of Pharmacy updated some sections of its rules, including an economic impact statement. All good intentions, of course, but there were a few problems with some of the provisions and language in those changes.

We outlined those in a letter to the board’s executive director, Kamlesh Gandhi, starting with a bit of underestimation when it comes to economic impact: It seems the board didn’t consider the new costs of compliance under the updated USP <797> standards — we’re talking up to $30,000 per stability study. 

There was also some unclear language in the proposed rules’ section on Current Good Compounding Practices (cGMP). Not only did they list an incorrect date for the publication of USP Chapters <795>, <797>, <800>, and <825>, they appeared to confuse whether — contrary to federal law — the board expected 503A pharmacies to comply with cGMP. (Of course, 503B facilities do have to comply.)

The section on API selection criteria was also confusing. The rule listed six criteria, but it sometimes used the word “or” between the criteria and sometimes used the word “and.” Even someone well versed in symbolic logic would have a hard time being confident of the board’s intent. We have an idea, of course, but that section could use a bit of cleanup.

There were some other issues with the proposed rules: No mention of FDA’s interim bulk lists, for example, and a possible omission of the updated NIOSH classification framework. There was some unclear language about compounding copies of FDA-approved, commercially available drugs, too. Still, these are proposed rules, so we’re confident the board will iron out all these wrinkles in the final version.