DEA v. Top RX Pharmacy Order

Registrant Actions - 2013

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[Federal Register Volume 78, Number 86 (Friday, May 3, 2013)]
[Notices]
[Pages 26069-26086]
From the Federal Register Online via the Government Printing Office [www.gpo.gov] 

[FR Doc No: 2013-10550]

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 12-59]

Top RX Pharmacy; Decision and Order

On November 8, 2012, Chief Administrative Law Judge (ALJ) John J. Mulrooney, II, issued the attached Recommended Decision. Neither party filed exceptions to the Recommended Decision.

Having reviewed the record in its entirety, I have decided to adopt the ALJ's recommended rulings, findings of fact, and conclusions of law, except as discussed below.\1\ I have also decided to adopt the ALJ's recommended order.

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\1\ In his discussion of Factor Five--such other conduct which may threaten public health and safety--the ALJ cited the Agency's decision in Paul Weir Battershell, 76 FR 44359, 44368 n.27 (2011), for the proposition that "although a registrant's non-compliance with the Food, Drug, and Cosmetic Act is not relevant under Factor Five, consideration of such conduct may properly be considered on the narrow issue of assessing a respondent's future compliance with the CSA." Recommended Decision at 53 (slip op.) (emphasis added). However, as Battershell makes clear, it is not the case that such conduct is irrelevant under factor five, but simply, that such conduct, by itself, is not dispositive of whether a respondent's continued registration is consistent with the public interest. See 76 FR at 44368 n.27. Thus, evidence of non-compliance with provisions of the FDCA is relevant "for the limited purpose of assessing the likelihood of [a] [r]espondent's future compliance with the CSA." Id. (citing Wonderyears, Inc., 74 FR 457, 458 (2009)); see also 4 OTC, Inc., 77 FR 35031, 35032-33 (2012).

Also, in his discussion of Respondent's failure to accept responsibility, the ALJ opined that "[t]here is nothing in the record to rebut the persuasive record evidence that the conduct of the owner and PIC exceeded inaction and rose to the level of willing complicity in controlled substance diversion on a massive scale." Recommended Decision at 56. I agree that the evidence clearly shows that Respondent's principals knowingly diverted controlled substances. However, to the extent the ALJ's reasoning suggests that "inaction" on the part of a pharmacy's principals in dispensing prescriptions does not violate their duty under federal law to dispense only those prescriptions which have been "issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice," 21 CFR 1306.04(a), it is inconsistent with federal law. See United States v. Seelig, 622 F.2d 207, 213 (6th Cir. 1980) (upholding jury instruction that knowledge may be inferred from evidence that pharmacists "deliberately closed their eyes to what would otherwise be obvious to them"); Grider Drug #1 & Grider Drug #2, 77 FR 44070, 44097 (2012) (quoting Ralph J. Bertolino, 55 FR 4729, 4730 (1990) ("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 prescriptions.")). As these cases make clear, inaction on the part of a pharmacist who fills a prescription can by, itself, support a finding of a violation of 21 CFR 1306.04(a) and the revocation of a registration.

As the ALJ noted earlier in his decision, when the circumstances surrounding a prescription present a red flag as to the prescription's legitimacy, that red flag must be resolved conclusively to show that the prescription is legitimate prior to dispensing it. Recommend Decision at 44. Indeed, the circumstances surrounding the prescription may be such that it cannot be dispensed. See Holiday CVS, L.L.C., d/b/a CVS/Pharmacy Nos. 219 and 5195, 77 FR 62316, 62317-22 (2012).

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Order

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