DEA Audit Attorney in Contra Costa County

DEA Rules Can Get Complicated

Many violations are the fault of such complex rules that the average medical practitioner or pharmacist can inadvertently step outside of the vague and often discretionary rules. The following is from a 2022 federal case where (in a footnote) the federal court summarized some of the DEA rules. It is akin to studying quantum physics. The basic rules are outlined. That part is easy – but specifically what are the rules? What are the standards? The rules describe WHAT but not HOW and not WHY.

As DEA registrants in the closed-delivery system established by the CSA and its implementing regulations for the flow of controlled substances through the pharmaceutical supply chain, see 21 U.S.C. §§ 801 et seq.; 21 C.F.R. §§ 1301 et seq., participants in each of these sectors bear significant and independent responsibilities to ensure the safety and integrity of the supply of prescription opioids to the public, including the essential duty to provide effective controls and procedures to guard against diversion of these controlled substances. See CT1 MSJ Order re CSA Duties at 14–19 (docket no. 2483) (In re Opiate, 2019 WL 3917575, at *7-9 (N.D. Ohio Aug. 19, 2019)) (the CSA and its implementing regulations require manufacturers and distributors to: design and operate a system to identify suspicious orders of controlled substances, inform the DEA of suspicious orders when discovered, and not ship such orders unless due diligence reasonably dispels the suspicion); Order Denying MTD at 15 (docket no. 3403), In re Opiate, 477 F. Supp.3d 613, 624-25 (N.D. Ohio 2020) (21 C.F.R. § 1301.71(a) requires all DEA registrants, including manufacturers, distributors, and pharmacies, to provide effective controls and procedures to guard against diversion of controlled substances); Daubert Order re Rafalski at 3–5 (docket no. 3929), In re Opiate, 2021 WL 4060359, at *2-3 (N.D. Ohio Sept. 7, 2021) (citing Rafalski CT3 Rpt. at 8–9).

In re National Prescription Opiate Litigation (N.D. Ohio, Aug. 17, 2022, No. 18-OP-45032) 2022 WL 3443614, at *29, judgment entered (N.D. Ohio, Aug. 22, 2022, No. 1:17-MD-2804) 2022 WL 4099669

The courts are completely aware of the ambiguity. Another federal lcourt in City of Huntington v. AmerisourceBergen Drug Corporation (S.D.W. Va., July 4, 2022, No. CV 3:17-01362) 2022 WL 2399876, at *11 outlined the subjectivity of the rules:

Substantial compliance with the relevant security requirements may be deemed sufficient by the DEA. 21 C.F.R. § 1301.71(b). “A registrant’s regulatory obligations under the CSA, … and [its] implementing regulations do not require strict compliance. Only substantial compliance is required.” In re Nat’l Prescription Opiate Litig., No. 1:17-MD-2804, 2021 WL 3917174, at *3 (N.D. Ohio Sept. 1, 2021). “A determination of substantial compliance … is a fact-intensive inquiry … and whether a defendant has substantially complied with the CSA is a question of fact.” Id.; see also In re Nat’l Prescription Opiate Litig., No. 1:17-MD-2804, ––– F.Supp.3d ––––, ––––, 2022 WL 671219, at *6 (N.D. Ohio Mar. 7, 2022) (“[T]he ultimate determination of whether a defendants’ compliance was substantial, or whether it falls somewhere short of that mark, is best left to a jury.”).

City of Huntington v. AmerisourceBergen Drug Corporation (S.D.W. Va., July 4, 2022, No. CV 3:17-01362) 2022 WL 2399876, at *11

Our office has serious constitutional concerns regarding these vague rules. We believe that these vague rules violate the constitution. We look at the decision of the U.S. Supreme Court in Connally v. General Construction Co. (1926). In Connally the court held that a law is unconstitutionally vague when people “of common intelligence must necessarily guess at its meaning.” Whether or not the law regulates free speech, if it is unduly vague it raises serious problems under the due process guarantee, which is applicable to the federal government by virtue of the Fifth Amendment and to state governments through the Fourteenth Amendment.

 In Kolender v. Lawson (1983), the Supreme Court explained that “the void-for-vagueness doctrine requires that a penal statute define the criminal offense with sufficient definiteness that ordinary people can understand what conduct is prohibited and in a manner that does not encourage arbitrary and discriminatory treatment.”

This void for vagueness defense works with many aspects of medical regulation because the rules are often political and sometimes not clearly expressed. We have used this defense in medical board cases and criminal cases as well.