DEA Priority 1: Telehealth Prescribing and Controlled Substances
The DEA's handling of telehealth prescribing for controlled substances continues to evolve. After multiple extensions of the COVID-era flexibilities, the agency has finalized a framework that imposes new documentation requirements on pharmacies dispensing controlled substances prescribed via telehealth.
Under the updated rules, pharmacies must verify that the prescriber has met the required standard for patient evaluation - which varies by schedule and substance type. For Schedule II prescriptions originating from a telehealth encounter, pharmacies need to document that the prescriber has confirmed compliance with the applicable telemedicine exception under 21 U.S.C. 802(54).
The practical impact is straightforward: pharmacies that fill a significant volume of telehealth prescriptions for controlled substances need to update their verification procedures. The DEA has indicated that pharmacy-level enforcement for telehealth-related violations will increase in 2026, particularly targeting pharmacies that serve as preferred dispensing locations for high-volume telehealth prescribers.
DEA Priority 2: ARCOS Reporting Accuracy
The Automation of Reports and Consolidated Orders System (ARCOS) is getting more attention. The DEA has enhanced its data analytics capabilities to identify pharmacies with unusual ordering patterns faster, and the threshold for triggering an investigation has lowered.
Pharmacies should ensure their ARCOS reports are accurate and timely. Common issues include:
- Mismatched quantities between ordering records and ARCOS reports
- Delayed submissions that create apparent gaps in the supply chain
- Failure to report returns and transfers, which create inflated distribution figures
- Inconsistent reporting across multiple pharmacy locations under the same DEA registration
The DEA has also increased coordination with state PDMPs (Prescription Drug Monitoring Programs), creating cross-referenced datasets that flag pharmacies with high dispensing volumes that do not correlate with their ordering patterns.
DEA Priority 3: Corresponding Responsibility Enforcement
The DEA is doubling down on pharmacist corresponding responsibility - the legal obligation to ensure that a prescription is issued for a legitimate medical purpose before dispensing. This has been a priority for several years, but enforcement actions in late 2025 signal a more aggressive posture.
Recent cases have targeted pharmacies that continued filling prescriptions from prescribers who were under investigation, sanctioned, or exhibiting prescribing patterns inconsistent with legitimate medical practice. The DEA's position is that pharmacies have both the ability and the obligation to identify red flags and refuse to dispense when warranted.
For pharmacies, this means documenting your red flag resolution process is more important than ever. When a pharmacist identifies a concern - pattern fills, early refills, long-distance prescribers, cash-only patients - there must be a documented process showing that the concern was investigated and resolved before dispensing.
FDA Priority: Compounding Pharmacy Oversight
The FDA continues to sharpen its oversight of pharmacy compounding, particularly for pharmacies operating under Section 503A (patient-specific compounding). Areas of focus for 2026 include:
Beyond-use dating documentation. Pharmacies must demonstrate that their assigned beyond-use dates are supported by stability data or USP standards. The FDA has cited multiple pharmacies for assigning extended beyond-use dates without supporting documentation.
Sterile compounding compliance. Pharmacies performing sterile compounding face increased scrutiny around environmental monitoring, personnel competency testing, and media fill validation. The FDA's inspection cadence for 503A sterile compounders has increased, and deficiency findings are being shared with state boards of pharmacy for parallel enforcement.
Essentially a copy determinations. The FDA is more actively enforcing the prohibition on compounding drugs that are "essentially a copy" of commercially available products. Pharmacies that compound medications that closely mirror FDA-approved formulations need to carefully document the clinical basis for compounding each prescription.
CMS Updates: Medicare Part D Oversight
CMS has expanded its Part D audit scope for 2026 with two notable changes:
First, the agency is increasing the use of data analytics to identify audit targets. Rather than random sampling, CMS and its Plan Sponsors are using claims data patterns - unusual dispensing volumes, high rejection-resubmission rates, and outlier pricing - to select pharmacies for audit.
Second, CMS is requiring Plan Sponsors to audit a larger percentage of their pharmacy networks annually. This means more pharmacies will receive audit notifications in 2026, and the likelihood of any individual pharmacy being audited has increased.
State-Level Regulatory Trends
Several state-level trends are worth tracking:
Mandatory compliance programs. At least four additional states are considering legislation that would require retail pharmacies to maintain formal compliance programs. Currently, roughly 12 states have some form of compliance program requirement.
Enhanced inspection authority. Several states have expanded their boards of pharmacy's inspection authority, including the ability to conduct unannounced inspections outside normal business hours and to request electronic records remotely before an on-site visit.
Technician scope expansion. As states expand pharmacy technician scope of practice (immunizations, point-of-care testing), the associated documentation and training requirements are expanding correspondingly. Pharmacies utilizing expanded technician roles need to ensure their training and supervision documentation meets the new standards.
Preparing for 2026
The common thread across all these priorities is documentation. The regulators are not changing what pharmacies do - they are increasing their scrutiny of how pharmacies document what they do. The pharmacies that have robust, systematic documentation processes will navigate 2026 without disruption. Those relying on ad hoc recordkeeping face increasing risk.
The time to shore up your documentation systems, verify your controlled substance processes, and confirm your training records is now - before the enforcement priorities become enforcement actions at your door.
