Rhode Island: Don’t reinvent the wheel

Rhode Island’s board of pharmacy is updating its pharmacy regulations, and APC has weighed in with a detailed comment letter aimed at preventing confusion and unnecessary restrictions on compounding pharmacies.

One example: The draft rules lump traditional pharmacy compounding in with commercial drug manufacturing, pretty much treating pharmacists like drug factories and contradicting federal Controlled Substances Act.

We also flagged inconsistent language in the draft. The proposed rules bounce between terms like “products” and “preparations” when describing compounded medications. In USP terminology, though, only manufactured drugs are “products.” What’s wrong with “compounded sterile preparations” and “compounded nonsterile preparations”?

Another eyebrow-raiser: The draft includes a definition of “cancer drug” that requires those drugs to be “non-harmful” and administered only by a licensed professional. But FDA doesn’t classify drugs as “non-harmful,” and cancer-related medications are routinely prescribed for home use. APC asked the board to revise this language to match federal standards and avoid limiting patient access.

We had some other recommendations that also fell into the category of “Don’t reinvent the wheel,” including aligning references to USP <795> and <797> with national implementation dates, expanding the definition of allowable bulk drug ingredients to match section 503A of the FD&C Act, and clarifying what counts as “essentially a copy” of a commercial product.

“These clarifications,” we wrote, “would strengthen regulatory consistency, avoid unintended restrictions on legitimate compounding, and continue supporting patient-specific care in Rhode Island.”