Louisiana Board of Drug and Device Distributors public meetings in 2023
4 substantive meetings from 2023, with official agendas or minutes and plain-English summaries.
Louisiana Board of Drug and Device Distributors
The Board will review compliance matters, including a consent agreement and a hearing. The meeting also includes discussions on budget amendments for FY2024 and proposals for FY2025.
- Consent Agreement, Docket DA230029
- Hearing, Docket 2023DA0028
- Proposed amendments to FY2024 budget
- Proposed FY2025 budget
- Service charge for electronic fee payments
The Board approved budget amendments for FY2024 and adopted the proposed budget for FY2025. Other actions included approving a disciplinary consent agreement and a training contract with NADDI. The Board also raised the two-signature requirement for checks to $15,000.
- Approved consent agreement for disciplinary case DA230029, Ervin and Associates, LLC (5-0-1)
- Approved request for continuance for disciplinary case 2023DA0028 (6-0-0)
- Approved September 12, 2023 meeting minutes (7-0-0)
- Approved FY2024 budget amendments for July 1, 2023 through June 30, 2024 (7-0-0)
- Approved and adopted proposed FY2025 budget for July 1, 2024 through June 30, 2025 (7-0-0)
- Approved Cooperative Endeavor Agreement with NADDI for training fees not to exceed $6,500 (7-0-0)
- Approved raising the two-signature check limit to $15,000 and above (7-0-0)
Louisiana Board of Drug and Device Distributors
The Louisiana Board of Drug and Device Distributors will meet to discuss new business including a federal prohibition on wholesaling under Section 503B of the FD&C Act and an assessment of drug and device regulations. Old business includes updates on FDA national standards for licensure, the 2023 legislative session's Senate Bill 201 on remote meetings, compliance management, suspicious/ excessive order tracking, and an online public records portal. The board will also consider renewing an accounting services contract and approve meeting minutes from June 13, 2023.
- Discussion of Prohibition on Wholesaling, Section 503B of the Federal FD&C Act
- Assessment of Drug and Device Regulations
- Update on FDA National Standards for Licensure of Wholesalers and 3PLPs
- Update on 2023 Legislative Session Senate Bill 201 on Remote Meetings
- Renewal of Accounting Contract (Service Contracts)
The Board approved a one-year contract for general accounting services and an amendment to a previous contract to increase its maximum amount. Other items, including financial reports and regulatory discussions, were reviewed without formal action.
- Approved June 13, 2023 meeting minutes (7-0)
- Approved accounting services contract with The Accountant Exec LLC for Oct 1, 2023 to Sept 30, 2024, not to exceed $4,000 (7-0)
- Approved amendment to accounting contract for Oct 1, 2022 to Sept 30, 2023, increasing maximum amount to $4,400 (7-0)
Louisiana Board of Drug and Device Distributors
The Louisiana Board of Drug and Device Distributors will hold its annual meeting to approve minutes, review financial statements, and renew service contracts for legal and facility inspection services. New business includes designating a records officer and discussing FDA national standards for wholesaler and 3PLP licensure. The board will also receive updates on legislative session outcomes, compliance management, and a suspicious/excessive orders tracking system using AI.
- Renewal of legal contracts for regulatory and compliance services
- Discussion of FDA National Standards for licensure of wholesalers and 3PLPs
- Update on suspicious order tracking with AI data entry platform
- Election of board officers
- Review of FY2023 budget outlook and annual attestation questionnaire
The Board approved several service contracts for legal and inspection services for the 2023-2024 term. Members also ratified current board officers and approved a 5% merit salary adjustment for Executive Director George Lovecchio. A new committee was formed to review FDA national standards for wholesaler and 3PLP licensure.
- Approved legal services contract with The Becknell Law Firm, APLC not to exceed $35,000 (Voice Vote)
- Approved legal services contract with Celia R. Cangelosi not to exceed $10,000 (Voice Vote)
- Approved facility inspection contract with Danny Andrus not to exceed $42,000 (Voice Vote)
- Approved 5% merit salary adjustment for Executive Director George Lovecchio (Voice Vote)
- Adopted FY2023 Annual Attestation Questionnaire and Resolution (Voice Vote)
- Ratified current board officers for another year of service (Voice Vote)
- Re-designated George Lovecchio as records officer effective July 1, 2023 (Voice Vote)
- Created committee to review FDA national standards for wholesaler and 3PLP licensure (Voice Vote)
Louisiana Board of Drug and Device Distributors
The Louisiana Board of Drug and Device Distributors will meet to approve minutes, review financial statements, and discuss service contract renewals for facility inspections and compliance management. New business includes a preview of the 2023 Louisiana legislative session and FDA guidance on suspect and illegitimate products. Board matters cover non-reporting of suspicious opioid sales, licensing fee comparisons, and inspection form recommendations.
- Review of compliance management contract amendment for current year
- Contract renewals for facility inspections and compliance management consulting
- Preview of 2023 Louisiana legislative session and review of bills filed
- Discussion of non-reporting of suspicious opioid sales cases
- Comparison of in-state versus out-of-state licensing fees
The Board approved two service contracts for the term of April 1, 2023, through March 31, 2024. Members also decided that all Board members must now review the ethics policy and provide signed annual verification.
- Approved December 13, 2022 meeting minutes (7-0-0)
- Approved facility inspection contract with John Liggio at a maximum of $22,000 (7-0-0)
- Approved increased inspection fees: low $190, moderate $245, and high $300 (7-0-0)
- Approved compliance management consulting contract with Victoria Bienvenu at a maximum of $60,000 (7-0-0)
- Decided all Board Members will review the ethics policy and provide signed annual verification