Orrin Hatch: “For some time, I have been disturbed over reports that the Drug Enforcement Administration has been imposing multiple…”

“For some time, I have been disturbed over reports that the Drug Enforcement Administration has been imposing multiple, substantial fines for what amount to minor pharmacy record-keeping violations. I am referring to cases in which no unauthorized person obtain control of controlled substances. Violations of sections 842(a)(5) and (10) of the Controlled Substances Act can result in penalties of $25,000 per violation. I understand that between 1989 and 1997, $50 million in such fines have been assessed. These provisions of the law adopt a strict liability standard for all record-keeping violations, even a minor error such as a mis-recording of a zipcode, or the insertion of a ditto mark. While we all favor strong regulation of controlled substances, a rule of reason should prevail here. For that reason, I am supportive of the thrust of the language contained in sections 118 and 199 of S. 2260. Section 118 adopts a 'knowingly' standard, rather than a strict liability standard. Section 119 gives the courts discretion in assessing a fine, unlike current law which is not permissive. In addition, this section lowers the maximum penalty per occurrence from $25,000 to $500. In combination, sections 118 and 119 may provide more correction than is warranted. For example, by adding a scienter requirement, while at the same time lowering the maximum fine, we may be creating an atmosphere in which sloppy record keeping is encouraged.”