Controlled Substance Reporting Isn’t Just for DEA Anymore

A memorable Florida Orange Growers’ television ad campaign in the late 1970s proclaimed that “Orange juice from Florida isn’t just for breakfast anymore.” The Federal Controlled Substances Act (“CSA”) and its regulations require Drug Enforcement Administration (“DEA”) registrants to submit certain reports related to narcotic drug transactions, thefts and significant losses, and suspicious orders. However, some DEA registrants may not realize that they may also have to submit the same or similar reports to their state professional boards or controlled substance authorities. They do not know that controlled substance reporting isn’t just for DEA anymore.

DEA registrants include manufacturers, distributors, importers, exporters, practitioners, pharmacies, hospitals, and narcotic treatment centers who handle federally-controlled substances. State-controlled substance requirements generally mirror federal requirements, but there are some subtle and not so subtle differences. Let’s take a short stroll through a few federal and state controlled substance reporting requirements. Note that we are not focusing on listed chemicals here.

A. Transactions

1. DEA

Manufacturers and distributors must report all schedule I and II, schedule III narcotic, and GHB transactions, quarterly via DEA’s Automated Reports and Consolidated Ordering System (“ARCOS”). Manufacturers must also report selected schedule III and IV psychotropic drugs quarterly. 21 U.S.C. § 827(d)(1); 21 C.F.R. § 1304.33.

2. The States

About a dozen states require reporting controlled substance transactions to the responsible state authority. New York, for example, requires electronic reporting of all controlled substances to the state’s Bureau of Narcotic Enforcement. N.Y. Codes R. Regs., tit. 10, § 80.23(f). Texas requires reports of all controlled substance distributions in an ARCOS format. Tex. Health & Safety Code Ann. § 481.0766. Florida requires reporting all controlled substance receipts and distributions monthly also in ARCOS format, and zero transaction reports if no transactions occur in a calendar month. Fla. Stat. Ann. § 499.0121(14). Ohio also requires monthly controlled substance transaction reports, including zero reports, to the Ohio Automated Rx Reporting System. Oh. Admin. Code 4729:8-3-04. Several states, including California and Georgia require transaction reporting when requested by the California Board of Pharmacy and the Georgia Drugs and Narcotics Agency. Cal. Code Regs., tit. 16, § 1782; Ga. Code Ann. § 26-4-115(b)(11).

B. Thefts/Significant Losses

1. DEA

Registrants must notify the DEA Field Division Office in writing of the theft or significant loss of any controlled substance within one 1 business day of discovery. They must also submit a Report of Theft or Loss of Controlled Substances, a DEA Form 106, through DEA’s secure network application within 45 calendar days after discovery. 21 C.F.R. § 1301.74(c) and .76(b).

2. The States

The vast majority of states likewise require reporting controlled substance thefts and significant losses. Consistent with federal requirements, a number of states, such as Arizona, Colorado, and Delaware require submitting the DEA-106 that they submit to DEA. Ariz. Admin. Code § R4-23-1003(A)(2); 3 Colo. Code Regs. § 719-1:7.00.10; Del. Code Regs. 24 § 7.3.1-.2. Some states require reporting immediately or within 1 business day of discovery. Others have different timing requirements: Connecticut (72 hours); New Mexico (5 days); Nevada (10 days); Mississippi (15 days), and Colorado (30 days). Conn. Agencies Regs. § 21a-262-3(b); N.M. Code R. § 16.19.20.36B; Nev. Rev. Stat. § 453.568; 30-030 Miss. Code R. § 3001, Art. XXXII.4; 3 Colo. Code Regs. § 719-1:15.05.13.

Ohio requires reporting thefts or significant losses of any prescription drug, including controlled and non-controlled substances upon discovery, followed by a DEA-106 within 30 days. Oh. Admin. Code 4729:6-3-02. California, Kentucky, and New Hampshire require pharmacies to report. Cal. Code Regs. tit. 16, § 1715.6; Ky. Rev. Stat. § 315.335(1); N.H. Admin. Code § Ph 702.03(a). A few states require that registrants include and adhere to theft and loss reporting in their policies and procedures.

C. Suspicious Orders

1. DEA

Manufacturers and distributors must design and operate a system to identify suspicious orders of controlled substances, and inform the DEA Field Division in their area of suspicious orders or a series of orders when discovered. A suspicious order may include, but is not limited to:

1. Orders of unusual size;
2. Orders deviating substantially from a normal pattern; and
3. Orders of unusual frequency. 21 U.S.C. §§ 802(57), 832; 21 C.F.R. § 1301.74(b).

2. The States

For about half of the states, suspicious order criteria mirror DEA’s criteria and require registrants to identify and report suspicious orders. Several states, like Maryland, allow registrants to satisfy their reporting requirement by submitting the reports that they provide to DEA. Md. Code Ann., Crim. Law § 5-303(e). Georgia requires reports of excessive controlled substance purchases using DEA’s suspicious order criteria to the Georgia Drugs and Narcotics Agency. Ga. Code Ann. § 26-4-115(b)(2). Ohio and Washington require a report indicating that no suspicious orders were identified in a calendar month. Oh. Admin. Code 4729:6-3-05(F); Wash. Admin. Code § 246-945-585(1). Virginia requires registrants who cease distributing controlled substances because of suspicious orders to report to the Board of Pharmacy within 5 days. Va. Code Ann. § 54.1-3435.01(b). Idaho requires processes to be in place for monitoring customers’ purchase activity and suspicious ordering patterns. Idaho Code r. 24.36.01.250.02.

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So, registrants, the next time you submit a required federal report, remember the states because “controlled substance reporting isn’t just for DEA anymore.” (In some states reporting may never have been just for DEA.)