DEA Compliance FAQs

Our consultants handle every step of the DEA registration process, including selecting the correct form (DEA Form 224, 225, 363, or 510), preparing documentation, and addressing red flags that could delay approval. We also guide you through renewals and help resolve issues from prior applications.

Yes. GTC Consulting offers pharmacist DEA license support for initial applications, renewals, and compliance monitoring. Whether you’re opening a new pharmacy or maintaining an existing license, we help ensure all requirements are met so your DEA license remains in good standing.

A DEA business license consultant specializes in helping organizations navigate federal and state licensing for controlled substances. At GTC Consulting, we act as your compliance partner—streamlining paperwork, monitoring timelines, and ensuring your licenses align with evolving DEA regulations.

DEA compliance consulting ensures that your business follows all DEA regulations under the Controlled Substances Act. GTC Consulting provides compliance assessments, employee training, policy development, and ongoing monitoring. Our goal is to reduce risk, prevent violations, and keep your operations inspection-ready year-round.

A DEA audit service evaluates your record-keeping, controlled substances inventory, security controls, and reporting practices. GTC Consulting performs detailed mock DEA inspections so you can address potential violations before an official inspection. This proactive approach protects your DEA registration and reduces the risk of penalties.

DEA “Know Your Customer” (KYC) inspections confirm that your partners and clients are properly licensed and compliant. GTC Consulting conducts KYC inspections to help distributors and manufacturers verify supply chain integrity, reduce liability, and meet DEA due diligence standards.

Best practice is to conduct at least one comprehensive DEA compliance audit annually, with additional reviews after regulation changes or significant business events. GTC Consulting provides recurring audit services tailored to your operations, ensuring you’re always prepared for DEA inspections.

We conduct mock inspections, review records, and create corrective action plans tailored to your operations. Our experts—many with decades of DEA compliance experience—help ensure you’re confident and fully prepared when the DEA arrives.

Penalties range from fines and license suspension to criminal charges for severe violations. Non-compliance can also damage your business reputation and disrupt operations. GTC Consulting helps businesses avoid these risks with preventive audits, compliance programs, and inspection readiness strategies.

• Incomplete/inaccurate inventories
• Improper DEA Form 222 use
• Records not readily retrievable
• Delayed reporting of theft/loss
• Weak suspicious order monitoring documentation
• Lack of SOPs or training evidence

Penalties range from warning letters and civil fines to suspension or revocation of DEA registration. In severe cases, criminal charges may apply.

All DEA-required records must be maintained for at least 2 years under federal law. Some states require longer. Records must be readily retrievable.

Registrants must notify their local DEA Field Office in writing within one business day of discovery. The DEA Form 106 must then be completed and submitted electronically within 45 days - once the scope of the loss is determined.

Per 21 CFR 1301.74(b), an order of unusual size, unusual pattern, or unusual frequency may be deemed suspicious. Distributors must have a Suspicious Order Monitoring (SOM) program to detect and report these orders before shipping.

• Biennial Inventory: Required every 2 years; a physical count of all controlled substances on hand. Must specify “open of business” or “close of business.”
• Perpetual Inventory: Ongoing record of all controlled substance receipts and dispositions. Federally not required for all schedules, but many states mandate it.

Yes, but the distributor must hold appropriate state licenses in both the shipping and receiving states, along with DEA registration, and comply with all applicable laws.

Best practice: initial training at hire and annual refresher training covering security, recordkeeping, suspicious orders, and reporting obligations.

Yes. Pharmacies selling scheduled listed chemical products (like pseudoephedrine) must self-certify annually with DEA and comply with logbook, storage, and sales limit requirements.

• Schedule II: Generally, must be stored in a safe or vault meeting DEA specs. *Additional safeguards (alarms, cameras, panic buttons) may be required or recommended.”
• Schedule III–V: May be stored in a cage, locked cabinet, or dispersed in stock- depending on the DEA registration classification. *Additional safeguards (alarms, cameras, panic buttons) may be required or recommended.

A drug diversion prevention program is designed to prevent theft, misuse, or illegal distribution of controlled substances. GTC Consulting develops customized programs with employee safeguards, inventory controls, and monitoring systems. Our programs meet DEA expectations while protecting both your patients and your DEA license.

Pharmaceutical security strategies involve physical safeguards, storage controls, alarm systems, and monitoring protocols that meet DEA standards. GTC Consulting designs custom pharmaceutical security strategies to prevent diversion, theft, or unauthorized access to controlled substances.

During mergers or acquisitions, undisclosed DEA compliance issues can create significant financial and legal risks. GTC Consulting performs M&A liability evaluations to identify regulatory exposures, DEA registration problems, or diversion risks before deals close—helping protect your investment.

Investors in pharmaceutical or healthcare companies face unique DEA compliance risks. GTC Consulting’s risk advisory services evaluate compliance history, licensing gaps, and future liabilities to give investors a clear picture of potential risks before acquisition or partnership.

DEA regulations require monitoring for unusual or suspicious orders of controlled substances. GTC Consulting helps clients implement SOM systems that identify, flag, and report questionable orders. This ensures compliance while strengthening anti-diversion protections.