Quiero saber acerca de...

Federal Register / Vol. 86, No. 188 / Friday, October 1, 2021 / Notices applicable Florida state law based on the requirements by the State of Florida Department of Health Investigative Services before the DEAs on-site inspection.
Further, Pharmacy 4 Less also introduced a second state report dated September 5, 2017, which occurred after the DEAs on-site inspection. RX 14.
The report has a few discrepancies when compared to RX 15. The second report does not appear to be completely filled out, particularly at the end of the second page. Further, it does not have a signature page as that provided for in RX 15. However, when comparing both documents, it is clear that RX 14 was completed by a computer or some sort of electronic device, while RX 15 was completed by hand. This second report also demonstrates, in the same manner as RX 15, that the Florida inspector not only found Pharmacy 4 Less to be compliant with some federal regulations, but particularly with sections of Florida administrative regulations.
Both of these reports weigh in favor of Pharmacy 4 Less as evidence of their compliance with federal and state law, as determined by inspectors from the Florida Department of Health Investigative Services. However, the reports are not dispositive of the issues in this case, in particular the resolution of red flags, and the specific allegations in this case must still be addressed.
Standard of Care as to Charged Violations NNN
A physicians standard of care for prescribing is guided by federal and state law. A prescription for a controlled substance may only be filled by a pharmacist, acting in the usual course of his professional practice. 21
CFR 1306.06. According to the CSAs implementing regulations, a lawful controlled substance order or prescription is one that is issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. 21 CFR 1306.04a. While the responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, . . . a corresponding responsibility rests with the pharmacist who fills the prescription. Id. The regulations establish the parameters of the pharmacys corresponding responsibility.
An order purporting to be a prescription issued not in the usual course of professional NNN The added text in this section clarifies the analysis of a pharmacists corresponding responsibility under 21 CFR 1306.04a.

VerDate Sep<11>2014

20:19 Sep 30, 2021

Jkt 256001

treatment . . . is not a prescription within the meaning and intent of . . . 21 U.S.C. 829
. . . and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.

Id. The language in 21 CFR 1306.04
and caselaw could not be more explicit.
A pharmacist has his own responsibility to ensure that controlled substances are not dispensed for non-medical reasons.
Ralph J. Bertolino, d/b/a Ralph J.
Bertolino Pharmacy, 55 FR 4729, 4730
1990 citing United States v. Hayes, 595 F.2d 258 5th Cir. 1979, cert.
denied, 444 U.S. 866 1979; United States v. Henry, 727 F.2d 1373 5th Cir.
1984 reversed on other grounds. As the Supreme Court explained in the context of the CSAs requirement that schedule II controlled substances may be dispensed only by written prescription, the prescription requirement . . . ensures patients use controlled substances under the supervision of a doctor so as to prevent addiction and recreational abuse . . .
and also bars doctors from peddling to patients who crave the drugs for those prohibited uses. Gonzales v. Oregon, 546 U.S. 243, 274 2006.
To prove a pharmacist violated her corresponding responsibility, the Government must show that the pharmacist acted with the requisite degree of scienter. See 21 CFR
1306.04a The person knowingly filling a prescription issued not in the usual course of professional treatment . . . shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances. emphasis added. DEA
has also consistently interpreted the corresponding responsibility regulation such that when prescriptions are clearly not issued for legitimate medical purposes, a pharmacist may not intentionally close his eyes and thereby avoid actual knowledge of the real purpose of the prescription. Bertolino, 55 FR at 4730 citations omitted; see also JM Pharmacy Group, Inc. d/b/a Pharmacia Nueva and Best Pharmacy Corp., 80 FR 28667, 2867072 2015
applying the standard of willful blindness in assessing whether a pharmacist acted with the requisite scienter. Pursuant to their corresponding responsibility, pharmacists must exercise common sense and professional judgment when filling a prescription issued by a physician. Bertolino, 55 FR at 4730.
When a pharmacists suspicions are aroused by a red flag, the pharmacist must question the prescription and, if
PO 00000

Frm 00035

Fmt 4701

Sfmt 4703

54583

unable to resolve the red flag, refuse to fill the prescription. Id.; Medicine Shoppe-Jonesborough, 300 F. Appx 409, 412 6th Cir. 2008 When pharmacists suspicions are aroused as reasonable professionals, they must at least verify the prescriptions propriety, and if not satisfied by the answer they must refuse to dispense..
Finally, the corresponding responsibility to ensure the dispensing of valid prescriptions extends to the pharmacy itself. Holiday CVS, 77 FR at 62341 citing Med. Shoppe Jonesborough, 73 FR at 384; United Prescription Servs., Inc., 72 FR 50397, 5040708 2007; EZRX, L.L.C., 69 FR
63178, 63181 2004; Role of Authorized Agents in Communicating Controlled Substance Prescriptions to Pharmacies, 75 FR 61613, 61617 2010; Issuance of Multiple Prescriptions for Schedule II
Controlled Substances, 72 FR 64921, 64924 2007 other citations omitted.
The DEA has consistently held that the registration of a pharmacy may be revoked as the result of the unlawful activity of the pharmacys owners, majority shareholders, officers, managing pharmacist, or other key employee. EZRX, L.L.C., 69 FR at 63181;
Plaza Pharmacy, 53 FR 36910, 36911
1988. Similarly, knowledge obtained by the pharmacists and other employees acting within the scope of their employment may be imputed to the pharmacy itself. Holiday CVS, 77
FR at 62341.
In this matter, the Government did not allege that Respondent dispensed the subject prescriptions having actual knowledge that the prescriptions lacked a legitimate medical purpose. Instead, the Government alleged that Respondent violated the corresponding responsibility regulation for each of the patients at issue in this matter by filling prescriptions in the face of numerous red flags for which there was no evidence that they were ever resolved.
Govt Prehearing, at 8, and 914. Agency decisions have consistently found that prescriptions with the same red flags at issue here were so suspicious as to support a finding that the pharmacists who filled them violated the Agencys corresponding responsibility rule due to actual knowledge of, or willful blindness to, the prescriptions illegitimacy. 21 CFR 1306.04a; see, e.g., Pharmacy Doctors Enterprises d/b/
a Zion Clinic Pharmacy, 83 FR 10876, 10898, pet. for rev. denied, 789 F. Appx 724 11th Cir. 2019 long distances;
pattern prescribing; customers with the same street address presenting the same prescriptions on the same day; drug cocktails; cash payments; early refills;
Hills Pharmacy, 81 FR 49816, 4983639

E:FRFM01OCN2.SGM

01OCN2