Relating to patient authorization to access certain investigational sun protection products.

Contracts

• Manufacturer-Patient Agreements: Draft direct-to-patient supply agreements that explicitly state the transaction is for "cost recovery" only, not commercial sale.
• 3PL/Distribution Agreements: Amend vendor contracts to authorize the handling of "investigational/non-FDA approved" inventory, ensuring it is segregated from commercial stock to prevent accidental retail distribution.

Hiring/Training

• Clinical Staff Training: Physicians and intake staff must be trained on the specific eligibility workflow: verifying the patient has exhausted FDA-approved options and documenting that approved alternatives are "less effective" for the specific patient.

Reporting & Record-Keeping

• Informed Consent (Mandatory): You must create and retain a specific consent form signed by the patient acknowledging the product is not FDA-approved and assuming all liability. Without this specific document, statutory immunity is void.
• Phase 1 Verification Dossier: Manufacturers must maintain a compliance file proving the active ingredient has successfully completed Phase 1 clinical trials and remains under active investigation to survive a legal challenge regarding product eligibility.

Fees & Costs

• Cost Recovery Accounting: Manufacturers must establish a strict accounting methodology to calculate "costs associated with manufacture." The law prohibits charging a profit margin. Finance teams must isolate direct materials, labor, and logistics costs to justify the price point.