Voglio sapere a riguardo di…

Federal Register / Vol. 86, No. 125 / Friday, July 2, 2021 / Notices right to a hearing, or submitted a corrective action plan. Accordingly, I
find that Registrant has waived the right to a hearing and the right to submit a written statement and corrective action plan. 21 CFR 1301.43d and 21 U.S.C.
824c2C. I, therefore, issue this Decision and Order based on the record submitted by the Government, which constitutes the entire record before me.
21 CFR 1301.43e.
Findings of Fact Registrants DEA Registration Registrant is the holder of DEA
Certificate of Registration No.
FS7068249 at the registered address of 448 Jackson Pike, Gallipolis, OH 45631.
RFAAX 1 Certificate of Registration.
Pursuant to this registration, Registrant is authorized to dispense controlled substances in schedules II through V as a retail pharmacy. Id.

lotter on DSK11XQN23PROD with NOTICES1

The Status of Registrants State License On October 5, 2020, the State of Ohio Board of Pharmacy hereinafter, Board issued a Settlement Agreement with the State of Ohio Board of Pharmacy hereinafter, Settlement Agreement.
RFAAX 4, App. A. According to the Settlement Agreement, the Board had initiated an investigation of Registrant, a pharmacy licensed as a Terminal Distributor of Dangerous Drugs, and Brandon OCallaghan, owner and operator of Registrant, related to Mr.
OCallaghans illicit drug usage and failure to ensure Registrant met minimum standards and maintained sanitary compounding area conditions to ensure public safety. Id. at 1. The Settlement Agreement states that on or about June 19, 2019, the Board sent Registrant a Summary Suspension/
Notice of Opportunity for Hearing and that Registrant subsequently requested a hearing by and through counsel on or about July 15, 2019. Id. The hearing was held on or about November 5, 2019, and resulted in a Board Order that placed both Registrants license and Mr.
OCallaghans license on indefinite suspension subject to certain conditions. Id. at 2. According to the Settlement Agreement, on or about January 8, 2020, Mr. OCallaghan violated the terms of the Order by testing positive for amphetamine 454
ng/ml and methamphetamine 2368 ng/
ml. Id. According to the Settlement Agreement, Mr. OCallaghan subsequently surrendered his pharmacy license on May 5, 2020, and thus Registrant no longer had a Responsible Person or owner that was lawfully allowed to possess its license.
Id. Under the terms of the Settlement
VerDate Sep<11>2014

17:12 Jul 01, 2021

Jkt 253001

Agreement, Registrant permanently and voluntarily surrendered to the Board its license and registration. Id. at 2.
According to Ohios online records, of which I take official notice, Registrants state pharmacy license remains inactive.2 https elicense.ohio.gov/OH_
HomePage last visited date of signature of this Order. Accordingly, I find that Registrant is not currently licensed to dispense controlled substances in Ohio, the state in which Registrant is registered with the DEA.
Discussion Pursuant to 21 U.S.C. 824a3, the Attorney General is authorized to suspend or revoke a registration issued under section 823 of the Controlled Substances Act hereinafter, CSA
upon a finding that the registrant . . .
has had his State license or registration suspended . . . or revoked . . . by competent State authority and is no longer authorized by State law to engage in the . . . dispensing of controlled substances. With respect to a practitioner, the DEA has also long held that the possession of authority to dispense controlled substances under the laws of the state in which a practitioner engages in professional practice is a fundamental condition for obtaining and maintaining a practitioners registration. See, e.g., James L. Hooper, M.D., 76 FR 71,371
2011, pet. for rev. denied, 481 F. Appx 826 4th Cir. 2012; Frederick Marsh Blanton, M.D., 43 FR 27,616, 27,617
1978.
This rule derives from the text of two provisions of the CSA. First, Congress defined the term practitioner to mean a pharmacy . . . or other person licensed, registered, or otherwise permitted, by . . . the jurisdiction in which it practices . . ., to distribute, dispense, . . . or administer . . . a controlled substance in the course of professional practice. 21 U.S.C.
80221. Second, in setting the requirements for obtaining a 2 Under the Administrative Procedure Act, an agency may take official notice of facts at any stage in a proceedingeven in the final decision.
United States Department of Justice, Attorney Generals Manual on the Administrative Procedure Act 80 1947 Wm. W. Gaunt & Sons, Inc., Reprint 1979. Pursuant to 5 U.S.C. 556e, when an agency decision rests on official notice of a material fact not appearing in the evidence in the record, a party is entitled, on timely request, to an opportunity to show the contrary. Accordingly, Registrant may dispute my finding by filing a properly supported motion for reconsideration of finding of fact within fifteen calendar days of the date of this Order. Any such motion and response shall be filed and served by email to the other party and to Office of the Administrator, Drug Enforcement Administration at dea.addo.attorneys@dea.usdoj.gov.

PO 00000

Frm 00079

Fmt 4703

Sfmt 4703

35337

practitioners registration, Congress directed that the Attorney General shall register practitioners . . . if the applicant is authorized to dispense . . .
controlled substances under the laws of the State in which he practices. 21
U.S.C. 823f. Because Congress has clearly mandated that a practitioner possess state authority in order to be deemed a practitioner under the CSA, the DEA has held repeatedly that revocation of a practitioners registration is the appropriate sanction whenever he is no longer authorized to dispense controlled substances under the laws of the state in which he practices. See, e.g., James L. Hooper, 76 FR at 71,37172;
Sheran Arden Yeates, M.D., 71 FR
39,130, 39,131 2006; Dominick A.
Ricci, M.D., 58 FR 51,104, 51,105 1993;
Bobby Watts, M.D., 53 FR 11,919, 11,920
1988; Frederick Marsh Blanton, 43 FR
at 27,617.
Under Ohio law, a terminal distributor of dangerous drugs means a person who is engaged in the sale of dangerous drugs 3 at retail . . . and includes pharmacies . . . and all other persons who procure dangerous drugs for sale or other distribution by or under the supervision of a pharmacist . . . or any other person authorized by the board of pharmacy. Ohio Rev. Code Ann. 4729.01Q West 2021. Further, Ohio law provides that, other than a licensed terminal distributor of dangerous drugs and other inapplicable exceptions, no person shall do any of the following: a Sell or distribute, at retail, dangerous drugs; b possess for sale, at retail, dangerous drugs; c possess dangerous drugs. Ohio Rev.
Code Ann. 4729.51E1 West 2021.
Here, the undisputed evidence in the record is that Registrant surrendered its license as a terminal distributor of dangerous drugs in Ohio. As already discussed, a terminal distributor of dangerous drugs must be licensed to be authorized to possess or distribute controlled substances in Ohio. Thus, because Registrant permanently and voluntarily surrendered its Ohio state pharmacy license and, therefore, is not authorized to dispense controlled substances in Ohio, Registrant is not eligible to maintain a DEA registration.
Accordingly, I will order that Registrants DEA registration be revoked.
3 The definition of dangerous drugs includes a drug that may be dispensed only upon a prescription under revised code section 3719.
Ohio Rev. Code. Ann. 3719.41 states that the state board of pharmacy shall adopt rules establishing the schedules of controlled substances incorporating the five schedules of controlled substances under the federal drug abuse control laws.

E:FRFM02JYN1.SGM

02JYN1