-proposed 15-day deadline, DEA issued its final rule with the 45-day deadline.Implications for Registrants: Critical to Complete Form 106 Within 45 Calendar DaysDEA’s clarification of the deadline to file a completed Form 106 within 45 calendar days of discovery of the theft or loss will have significant consequences for DEA registrants, which include manufacturers, distributors, pharmacies, and practitioners that are registered to manufacture, distribute, or dispense controlled substances.This new 45-day deadline represents a greater opportunity for registrants to investigate the circumstances surrounding the theft or loss, and complete Form 106 accordingly. However, with a strict deadline in place, registrants will need to ensure that they have a compliance system in place that can adequately investigate the theft or loss, complete Form 106, and submit it to the local DEA Field Division Office within 45 calendar days. Failure to submit on time risks significant penalties pursuant to 21 U.S.C. § 842(c), including potential loss of registration to distribute controlled substances, civil fines, and criminal fines. Further, the small minority of registrants that file a Form 106 via paper submissions (DEA has reported that as of 2018, 99.5% of submissions of Form 106 were conducted electronically) will have to revise their compliance schemes to report through DEA’s electronic system.It must be noted that this rule does not revise 21 CFR § 1310.05(b)(1), which still requires registrants to report “unusual or excessive loss or disappearance of a listed chemical” using DEA Form 107 within 15 calendar days after being aware of the loss. This update also does not change the requirement under 21 C.F.R. § 1301.74(c) that all registrants must notify DEA of the theft or loss within one business day of discovery.Lingering Questions: Regulatory Vagueness Concerning “Discovery” of Theft and Loss and the Definition of a “Significant Loss”Despite DEA providing clarity on the method and deadline for f

It is now clear that the Department will also target the pharmacies that fill illegitimate prescriptions, and that pharmacists can no longer claim they are following “doctor’s orders” to avoid enforcement action. The action alleges that several pharmacies, their owner, and several pharmacists (collectively “Defendants”) knowingly dispensed controlled substances without a valid prescription in violation of 21 U.S.C. § 842(a)(1); knowingly and intentionally distributed and dispensed controlled substances outside the usual course of the professional practice of pharmacy, in violation of 21 U.S.C. § 841(a); and billed Medicare programs to pay for controlled substances that were not used for a medically accepted indication and lacked a legitimate medical purpose in violation of the FCA, 31 U.S.C. 3729, et seq.Controlled Substances Act Violations Under the CSA and implementing regulations, a prescription is legally valid only if it is issued for “a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” 21 C.F.R. § 1306.04(a).

In August 2018, the Department filed its first civil action under the CSA and FCA enjoining prescribers from “recklessly and unnecessarily distribut[ing] painkillers and other drugs.” It is now clear that the Department will also target the pharmacies that fill illegitimate prescriptions, and that pharmacists can no longer claim they are following “doctor’s orders” to avoid enforcement action.The action alleges that several pharmacies, their owner, and several pharmacists (collectively “Defendants”)knowingly dispensed controlled substances without a valid prescription in violation of 21 U.S.C. § 842(a)(1);knowingly and intentionally distributed and dispensed controlled substances outside the usual course of the professional practice of pharmacy, in violation of 21 U.S.C. § 841(a); andbilled Medicare programs to pay for controlled substances that were not used for a medically accepted indication and lacked a legitimate medical purpose in violation of the FCA, 31 U.S.C. 3729, et seq. Controlled Substances Act ViolationsUnder the CSA and implementing regulations, a prescription is legally valid only if it is issued for “a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.”

It is now clear that the Department will also target the pharmacies that fill illegitimate prescriptions, and that pharmacists can no longer claim they are following “doctor’s orders” to avoid enforcement action. The action alleges that several pharmacies, their owner, and several pharmacists (collectively “Defendants”) knowingly dispensed controlled substances without a valid prescription in violation of 21 U.S.C. § 842(a)(1); knowingly and intentionally distributed and dispensed controlled substances outside the usual course of the professional practice of pharmacy, in violation of 21 U.S.C. § 841(a); andbilled Medicare programs to pay for controlled substances that were not used for a medically accepted indication and lacked a legitimate medical purpose in violation of the FCA, 31 U.S.C. 3729, et seq. Controlled Substances Act ViolationsUnder the CSA and implementing regulations, a prescription is legally valid only if it is issued for “a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.”

20,520. In addition, it is unlawful for mail-order distributors to “negligently fail to self-certify” under 21 U.S.C. § 830 (by an amendment to 21 U.S.C. § 842(a)(10)).The interim rule is effective April 13, 2011. Note, however, that the law requiring self-certification became effective on April 10, 2011 (180 days after its enactment on October 10, 2010).

Summary JudgmentThe government also sought partial summary judgment in the matter. The government alleges that Dr. Paskon violated 21 U.S.C. § 842(a)(1), which provides that it is unlawful for any person to distribute or dispense controlled substances in violation of 21 U.S.C. § 829. Section 829 provides that controlled substances cannot be dispensed without a prescription issued by a practitioner.