{"id":89145,"date":"2025-07-15T09:17:19","date_gmt":"2025-07-15T14:17:19","guid":{"rendered":"https:\/\/www.mcguirewoods.com\/?post_type=insight&#038;p=89145"},"modified":"2025-07-15T09:17:22","modified_gmt":"2025-07-15T14:17:22","slug":"pharmacist-has-key-role-in-assessing-legitimate-medical-purpose-of-controlled-substance-prescriptions","status":"publish","type":"insight","link":"https:\/\/www.mcguirewoods.com\/client-resources\/alerts\/2025\/7\/pharmacist-has-key-role-in-assessing-legitimate-medical-purpose-of-controlled-substance-prescriptions\/","title":{"rendered":"Pharmacist Has Key Role in Assessing \u201cLegitimate Medical Purpose\u201d of Controlled Substance Prescriptions"},"content":{"rendered":"\n<p>Federal Controlled Substance Act regulations require that prescriptions for controlled substances be issued only for legitimate medical purposes by individual practitioners acting in their usual course of professional practice, and that a \u201ccorresponding responsibility rests with the pharmacist who fills the prescription.\u201d<a href=\"#_ftn1\" id=\"_ftnref1\">[1]<\/a> Knowingly filling a prescription that is not issued in the usual course of professional treatment is a violation of the federal Controlled Substances Act. While not often discussed, the \u201clegitimate medical purpose\u201d assessment imposes a dual obligation on providers and filling pharmacists to ensure that controlled substances being prescribed and dispensed are for legitimate medical purposes in the ordinary course. A pharmacy that does not empower its pharmacists to fulfill their gatekeeper role or does not take its pharmacists\u2019 concerns seriously risks significant penalties.<\/p>\n\n\n\n<p>The Drug Enforcement Administration\u2019s (DEA\u2019s) <a href=\"https:\/\/www.deadiversion.usdoj.gov\/GDP\/(DEA-DC-046R1)(EO-DEA154R1)_Pharmacist's_Manual_DEA.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">pharmacist manual<\/a> does not contemplate what pharmacists must consider for controlled substance prescriptions to be issued for legitimate medical purposes. The DEA also has not issued commentary or guidance on what steps pharmacists must take to assess legitimate medical purposes, but has <a href=\"https:\/\/www.deadiversion.usdoj.gov\/GDP\/(DEA-DC-13)%20Preventing%20Diversion.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">issued guidance<\/a> on how to assess diversion risks posed by practitioners\u2019 behavior. Diversion risk guidance, prior DEA commentary at conferences and DEA Final Orders highlight that pharmacists must monitor for \u201cred flags\u201d that may indicate illegitimate prescriptions and trigger enforcement actions or civil penalties.<a id=\"_ftnref2\" href=\"#_ftn2\">[2]<\/a> <\/p>\n\n\n\n<p><a href=\"https:\/\/www.deadiversion.usdoj.gov\/GDP\/(DEA-DC-002R1)(EO-DEA009R1)_RPH_Guide_to_RX_Fraud_Trifold_(Final).pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Common red flags<\/a> <a id=\"_ftnref3\" href=\"#_ftn3\">[3]<\/a> include:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Dispensing a high volume of controlled substances compared to similarly situated pharmacies.<\/li>\n\n\n\n<li>Receiving a high percentage of cash payments for controlled substances as opposed to insurance.<\/li>\n\n\n\n<li>Patients travelling to fill prescriptions, implying \u201cdoctor shopping.\u201d<\/li>\n\n\n\n<li>Not tailoring prescriptions to medical need by ordering virtually identical prescriptions for numerous patients.<\/li>\n\n\n\n<li>Prescriptions written by doctors for illnesses that are not consistent with their area of specialty.<\/li>\n\n\n\n<li>Prescribing the \u201choly trinity\u201d of opioids, benzodiazepines and muscle relaxants in combination (frequently abused controlled substances).<\/li>\n<\/ul>\n\n\n\n<p>Such suspicious activity can give rise to allegations that the pharmacist had a \u201creason to know\u201d the prescription might be illegitimate and should be addressed through diligent inquiry with the prescriber.<a href=\"#_ftn4\" id=\"_ftnref4\">[4]<\/a> Failure to react to signs of wrongdoing can expose pharmacists to accusations of willful blindness.<\/p>\n\n\n\n<p>Interference with a pharmacist\u2019s corresponding responsibilities can result in substantial liability for a pharmacy, and inadequate compliance oversight may enable or perpetuate unlawful prescribing activity. To mitigate regulatory risk, pharmacies should take several proactive measures.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Train pharmacists to identify red flags and empower them to act on concerns, including by conducting due diligence if a prescription appears suspicious and documenting rationale for approving or denying the prescription thereafter.<\/li>\n\n\n\n<li>Foster a culture of reporting, giving pharmacists the means to report concerns internally and escalate issues as needed.<\/li>\n\n\n\n<li>Demonstrate that pharmacists\u2019 concerns are taken seriously, investigated and addressed.<\/li>\n\n\n\n<li>Act as secondary gatekeepers by identifying and refusing prescriptions from providers exhibiting concerning prescribing behavior.<\/li>\n\n\n\n<li>Stay current with DEA guidance and evolving best practices in controlled substances dispensing.<\/li>\n<\/ul>\n\n\n\n<p>Pharmacies must recognize that their liability under the Controlled Substances Act for dispensing improper controlled substance prescriptions is direct, and pharmacists should approach each prescription for a controlled substance with a critical eye.<\/p>\n\n\n\n<p>McGuireWoods continues to monitor developments in controlled substances regulations and enforcement. For questions, reach out to the authors or your McGuireWoods contact.<\/p>\n\n\n\n<p><a><em>Special thanks to&nbsp;summer&nbsp;associate&nbsp;Katherine S. Janda who contributed to the alert. She is not licensed to practice law.<\/em><\/a><\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p><a href=\"#_ftnref1\" id=\"_ftn1\">[1]<\/a> 21 CFR \u00a7 1306.04<\/p>\n\n\n\n<p><a href=\"#_ftnref2\" id=\"_ftn2\">[2]<\/a> See Holiday CVS, L.L.C. d\/b\/a CVS\/Pharmacy Nos. 219 and 5195; Decision and Order<em>,<\/em>&nbsp;77 Fed. Reg. 62,316, 62,341 (Oct. 12, 2012); Jones Total Healthcare Pharmacy, L.L.C. and SND Health Care, L.L.C.; Decision and Order, 81 Fed. Reg. 79,188, 79,218-19 (Nov. 10, 2016); East Main Street Pharmacy; Affirmance of Suspension Order, 75 Fed. Reg. 66,149, 66,150 (Oct. 27, 2010).<\/p>\n\n\n\n<p><a href=\"#_ftnref3\" id=\"_ftn3\">[3]<\/a> See Holiday CVS, 77 Fed. Reg. at 62,318; see Gulf Med Pharmacy; Decision and Order, 86 Fed. Reg. 72,694, 72,695 (Dec. 22, 2021).<\/p>\n\n\n\n<p><a href=\"#_ftnref4\" id=\"_ftn4\">[4]<\/a> See Holiday CVS, 77 Fed. Reg. at 62,341 (quoting Bob\u2019s Pharmacy &amp; Diabetic Supplies; Revocation of Registration, 74 Fed. Reg. 19,599, 19,601 (Apr. 29, 2009)).<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Federal Controlled Substance Act regulations require that prescriptions for controlled substances be issued only for legitimate medical purposes by individual practitioners acting in their usual course of professional practice, and&#8230;<\/p>\n","protected":false},"author":20,"featured_media":0,"template":"","tags":[],"industry_tax":[58],"insight_type":[2331],"international_tax":[],"location_tax":[],"media_role":[],"people_tax":[3446,3721],"practice_tax":[148,185,214],"publication_type":[],"site_tax":[2],"class_list":["post-89145","insight","type-insight","status-publish","hentry","insight_type-alerts","practice_tax-healthcare-compliance","practice_tax-healthcare-transactions","practice_tax-healthcare-litigation"],"acf":[],"links_out":[],"links_in":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.9 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ 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