(a). A purchaser must make a copy of the original DEA Form 222 for its records and then submit the original to the supplier. The copy retained by the purchaser may be in paper or electronic form.
(b). A supplier may fill the order, if possible and if the supplier desires to do so, and must record on the original DEA Form 222 its DEA registration number and the number of commercial or bulk containers furnished on each item and the date on which the containers are shipped to the purchaser.
If an order cannot be filled in its entirety, it may be filled in part and the balance supplied by additional shipments within 60 days following the date of the DEA Form 222. No DEA Form 222 is valid more than 60 days after its execution by the purchaser, except as specified in paragraph (f) of this section.
(c). The controlled substances must be shipped only to the purchaser and the location printed by the Administration on the DEA Form 222, except as specified in paragraph (f) of this section.
(d). The supplier must retain the original DEA Form 222 for the supplier's files in accordance with §1305.17(c). Any supplier who is not required to report acquisition/disposition transactions to the Automation of Reports and Consolidated Orders System (ARCOS) under §1304.33(c) (such as a practitioner) must make and submit a copy of the original DEA Form 222 to DEA, either by mail to the Registration Section, or by email to DEA.Orderforms@usdoj.gov.
The copy must be forwarded at the close of the month (not the close of next month) during which the order is filled. If an order is filled by partial shipments, the copy must be forwarded at the close of the month during which the final shipment is made or the 60-day validity period expires.
(e). The purchaser must record on its copy of the DEA Form 222 the number of commercial or bulk containers furnished on each item and the dates on which the containers are received by the purchaser.
(f). DEA Forms 222 submitted by registered procurement officers of the Defense Supply Center of the Defense Logistics Agency for delivery to armed services establishments within the United States may be shipped to locations other than the location printed on the DEA Form 222, and in partial shipments at different times not to exceed six months from the date of the order, as designated by the procurement officer when submitting the order.
HHS Proposes Increasing Buprenorphine Patient Limit for Medication-Assisted Treatment.
With the goal of expanding access to medication-assisted treatment (MAT), United States Department of Health and Human Services (HHS) has proposed a rule that would permit qualified physicians to prescribe buprenorphine, the opioid use disorder treatment medication, to as many as 200 patients. Under current regulations, physicians who are certified to prescribe buprenorphine for MAT can only prescribe up to 30 patients initially and after one year can request authorization to prescribe up to a maximum of 100 patients. Substance Abuse and Mental Health Services Administration Principal Deputy Administrator Kana Enomoto states “there are long patient waiting lists for prescribers who have reached the 100 patient limit.”
Buprenorphine is a Food and Drug Administration (FDA)-approved drug used as part of MAT, a comprehensive way to address the recovery needs of individuals that combines the use of medication with counseling and behavioral therapies to treat substance use disorders, indicates the HHS press release. HHS Secretary Sylvia Burwell said the proposal “is critical in our comprehensive approach to addressing the serious opioid epidemic facing our nation.” More information about MAT and increasing the patient limit is available in the HHS fact sheet.
Written or electronic comments on the proposed rule must be submitted by May 31, 2016. The Federal Register notice contains instructions and additional information for submitting public comment.
Drug Enforcement Administration (DEA) has published its final rule rescheduling hydrocodone combination products from Schedule III to Schedule II in the Federal Register. The change imposes Schedule II regulatory controls and sanctions on anyone handling hydrocodone combination products, effective October 6, 2014.
DEA first published the proposed rules in March 2014, in response to a Food and Drug Administration recommendation.
DEA received almost 600 public comments regarding the proposed rules after they were published, with a small majority of the commenters supporting the change, a DEA press release notes.
Plan B One-Step, an emergency contraceptive, has been approved for unrestricted sales by the FDA after months of back-and-forth political battles between the Obama administration and federal courts. The morning-after pill is finally going over-the-counter. The Food and Drug Administration on Thursday approved unrestricted sales of Plan B One-Step, lifting all age limits on the emergency contraceptive.
Under a final rule (PDF) published in the Federal Register, the pain reliever tramadol is now classified as a Schedule IV controlled substance (CS). Starting August 18, 2014, Drug Enforcement Administration (DEA) will require manufacturers to print the "C-IV" designation on all labels that contain 2- [(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol (tramadol), including its salts, isomers, and salts of isomers.
The agency notes that every "DEA registrant who possesses any quantity of tramadol on the effective date of this final rule must take an inventory of all stocks of tramadol on hand as of August 18, 2014, pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03,1304.04, and 1304.11 (a) and (d)." In addition, all "prescriptions for tramadol or products containing tramadol must comply with 21 U.S.C. 829, and be issued in accordance with 21 CFR part 1306 and subpart C of 21 CFR part 1311 as of August 18, 2014."
br /> National Association of State Controlled Substances Authorities notes (PDF) that several states have already classified tramadol as a CS. To "provide a reasonable time for registrants to comply with the handling requirements" for a Schedule IV CS, DEA established the effective date of the final rule as 45 days from the date of publication.