FEATURE


position they were in prior to the new rule for drugs that have been par- tially administered. “The require- ments to document the name of the patient, drug discarded, dosage, date, etc.,


still remain in place,” Smith


says. “If the ASC is in a state where drain disposal is still available, that is an option. A more environmentally friendly option would be to purchase a device designed to sequester con- trolled substances If a device is used, the contents should not be disposed in the trash but as non-hazardous pharmaceutical waste. The ASC’s regulated medical waste vendor will most likely also have a pharmaceuti- cal waste disposal offering.” The drugs that need to be dis-


What you need to do to comply BY SAHELY MUKERJI Drug Disposal Rules Change


A


lthough few of the provisions in the US Drug Enforcement Admin-


istration’s (DEA) final rule on the dis- posal of controlled substances issued on September 9, 2014, affect ASCs, sur- gery centers need to be acutely aware of those provisions, which became effec- tive on October 9, 2014. “The section of the rule that


impacts ASCs is the requirement to render controlled substances ‘non-retrievable,’” says Charlotte A. Smith, senior regulatory adviser for Pharmacology Services at WM Sustainability Services in Houston, Texas. According to the rule, “Non- retrievable means, for the purpose of destruction, the condition or state to which a controlled substance shall be rendered following a process that permanently alters that controlled substance’s physical or chemical condition or state through irrevers- ible means and thereby renders the


20 ASC FOCUS MAY 2015 DEA Drug Disposal Rule


For more information, go to www.deadiversion.usdoj.gov/ drug_disposal


controlled substance unavailable and unusable for all practical purposes.” The DEA does not consider flush- ing to be a means of rendering the controlled substance non-retrievable. “This caused great concern through- out the health care community, and prompted a joint industry letter to DEA on October 6,” Smith says. “DEA then responded with a clarifi- cation letter on October 17 stating that the final rule was not intended to per- tain to controlled substances remain- ing after drugs had been dispensed or administered to patients.” This surprising outcome now leaves ASC personnel in the same


carded, however, such as expired medications, must still be managed according to the new rule, the DEA stated. So how should ASCs dispose of expired drugs? “Since at this time DEA only accepts incineration as a ‘non-retrievable’


technology, the


ASCs should contact their original supplier or a DEA-registered reverse distributor to manage these drugs through a transfer between regis- trants,” she says. “This is a somewhat laborious process, so the best answer is to carefully manage purchases and avoid outdates if possible.” In the final rule, the DEA also states that for “drug wastage”—substances that must be disposed of that remain in a syringe or vial—a DEA Form 41, Registrants Inventory of Drug Surren- dered (www.deadiversion.usdoj.gov/ 21cfr_reports/surrend/41_form.pdf) is not needed for health care provid- ers, she adds.


ASCA’s Role


In its comment letter in response to the proposed rule, ASCA had argued for greater flexibility in the rules that ASCs must follow to dispose of con- trolled substances. For starters, ASCA recommended that the DEA should


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