Notes on Functional Medicine, Compounded Drugs, and Regulatory Issues

Functional Medicine and Compounded Drugs

• Compounded Medications:
  • Customized medications without dyes, fillers, or unnecessary ingredients.
  • Offered when patients cannot tolerate traditional medications.

Addressing FDA Regulations

• Redundant Regulations:

  • Objective to eliminate regulations that impede patient access to compounded drugs.
  • Fix incompatibilities and clarify laws that prevent patient adherence to medication.

• Executive Order:

  • Required to eliminate 10 regulations for every new regulation adopted.

Infusion Benefits and Medicare Regulations

• Medicare Regulations:

  • Many regulations prohibit patients from receiving necessary medications.

• Oncology Patients:

  • Clarification of laws preventing medications from being mailed to patients, especially impacting those in rural areas.
  • Patients in rural East Tennessee face challenges in accessing medication due to transportation issues and restrictions on having others pick up their prescriptions.

• Home Infusions:

  • Objective to allow infusions to be administered at home.
  • Current regulations force patients, especially in rural areas, to receive infusions in hospitals, leading to unnecessary costs.
  • Home infusions are presented as part of common-sense reforms within HHS (Health and Human Services).