Is Over-the-Counter Product Compounding Allowed in Kentucky?

The March 2012 Newsletter of the Kentucky Board of Pharmacy contains the following question and answer:

II. Over-the-counter product compounding: is it permissible?
The answer is found in the definition in Statute KRS 315.010:
(5) “Compound” or “compounding” means the preparation or labeling of a drug pursuant to or in anticipation of a valid prescription drug order including, but
not limited to, packaging, intravenous admixture or
manual combination of drug ingredients. “Compounding” as used in this chapter, shall not preclude simple reconstitution, mixing, or modification of drug products prior to administration by non-pharmacists.
The definition states pursuant to or in anticipation of a prescription for the preparation or labeling of a drug. Per KRS 315.010:
(9) “Drug” means any of the following:
(a) Articles recognized as drugs or drug products in any
official compendium or supplement thereto;
(b)Articles, other than food, intended to affect the
structure or function of the body of man or other
animals;
(c) Articles, including radioactive substances, intended for use in the diagnosis, cure, mitigation,
treatment or prevention of disease in man or other
animals; or
(d)Articles, intended for use as a component of any
articles specified in paragraphs (a) to (c) of this
subsection;
Based on the definition provided in the statute, compounded
legend and nonlegend drugs must be pursuant to a valid prescription in Kentucky.

The newsletter can be found here.