Controlled Substances Policy (Federal and Texas Regulatory Alignment)

1. Purpose

This policy defines Avicenna Pharmaceutical’s standards and procedures for the handling, storage, distribution, documentation, monitoring, and compliance oversight of controlled substances in accordance with:

  • Federal law, including the Controlled Substances Act (DEA Schedules II–V)

  • Texas statutory and regulatory requirements governing controlled substances

  • Rules promulgated by the Texas State Board of Pharmacy (TSBP)

2. Regulatory Authority

Avicenna Pharmaceutical complies with all applicable federal and Texas state laws and regulations, including but not limited to:

  • Federal Controlled Substances Act and DEA regulations (21 CFR Parts 1300–1317)

  • Texas Controlled Substances Act and related statutes in the Texas Health and Safety Code §481 et seq.

  • Texas State Board of Pharmacy rules and administrative codes pertaining to controlled substances and their distribution and delivery practices Texas State Board of Pharmacy+1

3. Scope

This policy applies to:

  • All personnel responsible for controlled substance logistics and compliance

  • All controlled substances handled, stored, distributed, or documented by Avicenna Pharmaceutical

  • All transactions involving DEA Schedules II through V controlled substances

4. Controlled Substance Schedules

Controlled substances regulated under this policy include those in DEA Schedules II–V, categorized by abuse potential and medical use. These schedules are defined under federal law and adopted for compliance purposes under Texas pharmacy regulations Texas State Board of Pharmacy.

5. Provider Verification and Eligibility

Controlled substances are distributed only to:

  • Entities and practitioners with valid DEA registration

  • Licensed healthcare providers authorized to prescribe, dispense, or administer scheduled substances under Texas law

Verification processes include:

  • Confirmation of active DEA registration and state licensure

  • Screening against federal and state exclusion lists

  • Verification of prescriptive authority as required under Texas law (e.g., compliance with prescriptive delegation rules, where applicable) Texas Military Department

Avicenna Pharmaceutical does not distribute controlled substances to unverified, unauthorized, or non-DEA-registered recipients.

6. Texas-Specific Prescription and Delivery Compliance

Avicenna Pharmaceutical adheres to applicable Texas rules governing prescriptions and delivery of controlled substances, including:

  • Compliance with state requirements for prescription drug delivery, including record retention related to controlled substance deliveries Legal Information Institute

  • Maintenance of appropriate documentation for delivery and distribution in accordance with Texas Administrative Code requirements

7. Secure Handling and Inventory Controls

Controlled substances are stored, handled, and transported in secure conditions designed to:

  • Limit access to authorized personnel

  • Prevent theft, diversion, and unauthorized access

  • Maintain compliance with both DEA and Texas Board of Pharmacy recordkeeping standards

Annual inventory and segregation of controlled substances records are conducted in accordance with more stringent state inventory requirements where applicable NetCE.

8. Recordkeeping and Documentation

Avicenna Pharmaceutical maintains comprehensive records for all controlled substance activities, consistent with federal and Texas requirements, including:

  • Acquisition, distribution, and transaction records

  • Schedule-specific documentation and retention practices

  • Delivery records as required by the Texas Administrative Code

Records are maintained in a manner that is readily retrievable for compliance verification, inspection, and audit.

9. Operational Controls

Operational processes for controlled substances include:

  • Use of official DEA ordering systems (e.g., DEA Form 222 or electronic equivalent) for Schedule II transactions

  • Verification of quantity, legitimacy, and medical purpose prior to fulfillment

  • Maintenance of records indicating actual distribution dates, recipient details, and DEA registration numbers

10. Monitoring, Compliance Audits, and Enforcement

Avicenna Pharmaceutical conducts regular internal monitoring and compliance audits to assess adherence to:

  • DEA regulations for Schedules II–V

  • Texas controlled substance laws and Board of Pharmacy rules

  • Company policies and SOPs governing controlled substances

Findings are addressed promptly through corrective and preventive actions.

11. Reporting and Incident Response

Suspected loss, theft, diversion, or regulatory discrepancies are handled through established incident response protocols, including:

  • Immediate investigation and documentation

  • Reporting to the DEA and applicable Texas authorities in accordance with statutory and regulatory requirements

  • Use of appropriate reporting forms (e.g., DEA Form 106 where applicable)

12. Training

Personnel engaged in controlled substance activities receive regular training on:

  • Federal DEA requirements for controlled substances

  • Texas state law and Board of Pharmacy regulations

  • Company compliance obligations and reporting procedures

13. Prohibitions and Discipline

Avicenna Pharmaceutical strictly prohibits:

  • Distribution of controlled substances to unverified or unauthorized recipients

  • Non-compliant documentation or recordkeeping

  • Any conduct that could result in diversion, regulatory non-compliance, or harm to public safety

Policy violations may result in corrective action, termination of privileges, and reporting to relevant regulatory authorities.

14. Policy Review

This policy is reviewed periodically and updated as required to reflect changes in federal law, Texas statutes, and administrative rules.