Compliance in Ambulatory Surgical Centers and the Role of an ASC Consultant: What California Section 4190 Facilities Need to Know

As regulatory frameworks continue to evolve, Ambulatory Surgical Centers (ASCs) licensed under Section 4190 of the California Business and Professions Code must stay vigilant. While these centers aren’t full-service pharmacies, they are increasingly under the microscope of regulators such as the California State Board of Pharmacy, the Drug Enforcement Administration (DEA), and the FDA under the Drug Supply Chain Security Act (DSCSA).

If your ASC handles pharmaceuticals or controlled substances, here’s what you need to know to stay compliant in 2025 and beyond.

A surgical scene with a variety of medical instruments carefully arranged on a table, while surgeons in the background are focused on a procedure in progress.

1. California Board of Pharmacy Self-Assessments by the ASC Consultant

Every ASC licensed under Section 4190 must complete a self-assessment every two years, specifically by July 1 of every odd-numbered year. In addition, this assessment must be completed:

- Within 30 days of a change in the pharmacist-in-charge (PIC)

- Following any change in facility licensure or relocation

 These assessments are more than formalities—they are mandatory compliance records that must be kept on-site and made available for inspection for at least 3 years.

 2. Board of Pharmacy Inspections: What to Expect

Increased inspection frequency is becoming the norm, particularly for ASCs handling a growing volume of pharmaceuticals.

Inspectors typically evaluate:

- Drug storage and security

- Labeling and inventory control

- Records of drug acquisition and disposition

- Controlled substance logs

- Controlled substance inventory reconciliations

- Staff compliance with facility-specific protocols

Failure to maintain proper records or lapses in drug handling (e.g., expired medications or improper security) may result in immediate citations, follow-up inspections, or even disciplinary action.

3. DEA Inspections and Controlled Substance Handling

If your ASC maintains a DEA registration, be prepared for unannounced DEA audits.

Key areas of review include:

- Proper use and storage of Schedule II–V controlled substances

- Documentation using DEA Form 222 and CSOS forms

- Controlled substance inventory and audit trails

- Secure, restricted-access storage for narcotics

- Documented procedures for drug destruction and disposal

DEA penalties can be severe, ranging from fines to license suspension. To stay compliant, facilities should conduct internal audits and maintain robust inventory controls year-round.

4. The DSCSA and Drug Traceability

Even though ASCs are not traditional pharmacies, they fall under the "dispenser" category defined in the Drug Supply Chain Security Act (DSCSA). This means ASCs must ensure traceability of prescription drugs they handle.

Basic DSCSA compliance includes:

- Only accepting drugs from authorized trading partners

- Maintaining product tracing information (Transaction Info, History, and Statements)

- Keeping those records for at least six years

- Investigating and reporting any suspect or illegitimate drugs

A temporary FDA exemption for small dispensers (fewer than 25 full-time pharmacy staff) gives some breathing room until 2026—but ASCs are strongly encouraged to begin implementing traceability systems now.

5. Choosing the Right ASC Consultant Pharmacist: Why It Matters More Than Ever

With the growing complexity of pharmacy regulations, your choice of consultant pharmacist is no longer just a matter of compliance—it’s a strategic decision.

The pharmacist you work with should not only be licensed and experienced in California regulations, but also:

• Specialize in ambulatory surgical settings

• Understand the nuances of Section 4190 licensure

• Be well-versed in DEA and DSCSA requirements

• Provide hands-on support for audits, documentation, and training

  
  

An effective consultant pharmacist will:

• Assist with biennial self-assessments

• Conduct routine compliance audits

• Oversee controlled substance documentation and inventory

• Provide up-to-date policy guidance and staff education

  
  

Moreover, the right pharmacist can help you proactively identify compliance gaps before they become costly violations, and guide you through Board or DEA inspections with confidence. The days of consultant pharmacist coming in to check for expired medications and signing a report stating everything is good are a thing of the past.

🧠 Pro Tip: Don’t just look for someone to sign off on paperwork—look for a consultant who acts as a trusted compliance partner.

Final Thoughts

 Ambulatory Surgical Centers licensed under Section 4190 are increasingly responsible for full-spectrum pharmacy compliance. This means more documentation, deeper audits, and greater accountability.

 To stay ahead:

- Partner with the right consultant pharmacist

- Complete self-assessments on time

- Prepare thoroughly for Board and DEA inspections

- Develop internal audits and staff education programs

- Begin DSCSA preparations, even if exempt for now

Regulatory agencies are paying closer attention—and staying compliant is key to protecting both your patients and your operational integrity.