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On October 15, 2025, the Alabama Board of Pharmacy (Board) held a public hearing to consider permanent adoption of Rule 680-X-2-.40, “Non-Disciplinary Penalties.” This rule, which had been in effect since August under emergency authority, introduced a new framework for addressing certain administrative violations with structured fines rather than traditional disciplinary actions. Given that this rule frames “non-disciplinary” action, it is significant in many different ways for pharmacies, pharmacists, and other licenses doing business in Alabama. With the emergency rule set to expire in December, the hearing represented a pivotal opportunity for stakeholders to shape the final version.
At the October 15, 2025, public hearing, the Alabama Board of Pharmacy unanimously voted to withdraw the rule, citing concerns with conflicting laws. Critics of the new rule argued that the language of the rule conflicted with state transparency laws. Although the rule is now set to expire in December, the Board agreed to revise the rule with assistance from the Attorney General's office to ensure that the rule aligns with the state law and legislative feedback. The Board expects to present a revised version of the rule at its next meeting scheduled for November 19, 2025. Although subject to the possibility of certain revisions, licensees both in Alabama and holding Alabama non-resident permits should understand the rule, its reach and significance.
What the Rule Does
The rule established a clear schedule of administrative fines for technical or procedural violations that previously might have triggered disciplinary action or been handled informally. Key examples include:
Expired Permits
- $1,000 fine for operating in January with an expired license
- $1,500 plus $75 per prescription after January 31
Wholesalers Operating Past Renewal
- $1,750 plus $400 per invoice
Failure to Update Board Records
- $10/day for failing to report a supervising pharmacist change (up to $1,000)
- $500 for failing to report a designated representative change within 30 days
A key restriction of the rule required that once a non-disciplinary fine was issued for a specific violation, the same entity could not receive another non-disciplinary fine for that violation for 10 years. Any recurrence within that period was treated as a disciplinary matter.
Why This Rule Matters for Licensees
For in-state pharmacies and pharmacists, the rule changed day-to-day compliance risk but still allowed for non-disciplinary remedial measures. Important provisions of this rule included the following:
- Automatic Costs for Administrative
Issues
Minor delays, such as late renewals or reporting changes, now carry automatic fines, but allow for resolution outside the disciplinary process. - Escalation for Repeat Violations
A second occurrence of the same violation within 10 years will be treated as a disciplinary matter, with potentially more severe consequences. Although the opportunity to resolve these matters in a non-disciplinary manner is a positive development, repeated occurrences can quickly result in disciplinary action. This should serve as a stark reminder to avoid such issues altogether even where non-disciplinary remedies exist.
Why Nonresident Pharmacies and Out-of-State Licensees Should Care
The rule applied to any entity holding an Alabama-issued permit or license, including out-of-state pharmacies shipping into Alabama, servicing Alabama patients, wholesalers and mail-order operations. Nonresident entities should be alert to the fact that even if your business is located outside Alabama, violations tied to your Alabama permit can result in fines. In addition, administrative delays tied to an Alabama permit can trigger fines.
Legal and Procedural Questions Remain
Several unresolved issues made this proposal particularly significant:
- Emergency Authority Under Scrutiny
Critics argue the Board may have lacked grounds for emergency rulemaking. - Statutory Limits
Some stakeholders believe the Board's actions may exceed the authority granted by Act 2025-372. - Transparency Concerns
Early drafts reportedly sought to exempt fines from public records requests, raising objections about transparency. The Board countered that this was to preserve the Pharmacy's standing with payors and other Boards of Pharmacy. - Due Process
The streamlined fine process could limit opportunities for licensees to contest penalties before they are imposed.
These issues are fueling legal challenges and heightened stakeholder interest.
What to Expect at the November 19 Hearing
The hearing will present a revised version of the rule and advance the rule from emergency status towards permanent adoption. This process is expected to include the following:
- Public Comment Opportunity
Pharmacies, pharmacists, wholesalers, attorneys, advocacy groups and other industry stakeholders can provide input. - Board Presentation
The Board will likely defend the updated/revised rule as a necessary tool for enforcing technical compliance efficiently but providing pharmacies with non-disciplinary remedies. - Potential for Revisions
Stakeholder feedback may prompt further changes to penalty amounts, procedures, or rule scope. - Next Steps
If a new rule is adopted, the revised rule will likely replace the emergency version in December unless further legal challenges arise.
Why Monitoring This Rule is Essential
Pharmacy entities inside and outside Alabama should keep this rule on their radar for several reasons including the following:
- Operational Impact
Compliance systems may need updates to avoid inadvertent violations and fines. - Potential to Set National Precedent
Alabama's approach could influence similar rules in other states. - Opportunity to Shape the Outcome
Participation—either in person or via written comment—can influence the final rule.
Summary of Key Takeaways:
- Rule 680-X-2-.40 introduced fines for administrative violations and was previously being enforced under emergency authority.
- Both in-state and out-of-state licensees holding Alabama permits are affected by these potential changes.
- Proactive compliance and ongoing monitoring are essential, especially for multi-state operators navigating new non-disciplinary remedies.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
