Guidance Documents

This is a guidance letter clarifying the circumstances under which oral schedule II prescriptions are permitted and provides temporary exceptions due to the COVID-19 Public Health Emergency declared by the Secretary of Health and Human Services. 

On March 26, 2020, due to the HHS declared health crises, DEA has granted an exception to 21 CFR 1305.13 regarding the requirement that a purchaser mail a hard copy version of DEA Form 222 to the original supplier in order to ensure an adequate supply of controlled substances for the duration of this public health emergency.

Due to the current public health crisis declared by HHS on 1-31-20, DEA grants an exception of 21 CFR 1303.24(b) that normally require the inventory for individual manufacturers to remain at 65% or less.  All DEA reg. bulk manufacturers are allowed to exceed the 65% ceiling in order to supply dosage form manufacturers with the active pharmaceutical ingredient(s). This exception does not authorize any manufacturer to exceed his previously established annual manufacturing quota.

Due to the COVID-19 public health emergency declared by HHS on 1-31-20, the DEA is granting an exception to the requirement that a practitioner be registered in each state where they dispense controlled substances. However, under this temporary exception, practitioners may dispense controlled in states where they do not hold a registration, provided that they still hold at least one registration, and comply with all applicable state laws.

DEA’s regulations prohibiting mail delivery of methadone to NTP patients remain in effect. DEA believes that the potential for diversion and abuse of methadone for MAT treatment of narcotic dependent persons is too high to permit NTPs to dispense via the USPS. To ensure continued access during the COVID-19 health emergency, DEA has authorized NTP employees, law enforcement and National Guard personnel to deliver methadone to patients who cannot travel to the NTP.

On March 21, 2020, the Drug Enforcement Administration issued guidance concerning the refill of schedule II through V controlled substances during the COVID-19 national health emergency.

On January 31, 2020, Department of Health and Human Services Secretary Azar declared a public health emergency due to the COVID-19 virus. This documents answers DEA registrants questions concerning the practice of telemedicine during this national health emergency.

DEA reviewed the request for an exception to 21 CFR 1301.74(i), and took into account the safeguards against diversion incorporated into the guidance for Opioid Treatment Programs, and granted the exception to 21 CFR 11301.74(i), but only to the extent that such activities will take place during the HHS-declared public health emergency.

The ATF Open Letter issued to All Michigan Federal Firearms Licensees on March 24, 2006 is rescinded as of the date of this letter because, as explained above, a valid Michigan State Concealed Pistol License (CPL) is no longer a NICS alternative under 18 U.S.C. § 922(t). All Michigan FFLs are required to conduct a NICS background check prior to the transfer of a firearm to a non-licensee, even if that individual possesses a valid, unexpired CPL.

Information for STOP Violence Against Women Formula Grant recipients on calculating match for the purpose of meeting the statutory requirement that an award under the program cover no more than 75 percent of the total costs of the project(s) funded.