Current status: In 2024, the FDA removed BPC-157 from 503B outsourcing facility compounding
Qualifying reasons under 503A include: Allergy to phenol or another preservative in the commercial formulation Need for a dose strength not commercially available (e.g., 1.5 mg, which falls between Ozempic's 1 mg and 2 mg pens) Inability to use the pen injector device due to dexterity issues (though this is weak because vial-and-syringe versions could theoretically be requested from Novo Nordisk) The FDA has historically taken a narrow view of what constitutes a legitimate patient-specific need, and "I prefer the compounded version" or "the commercial version is too expensive" do not qualify
The primary outcome was time-to-first occurrence of major adverse cardiovascular events (MACE
Infants may require a lactose free formula (or a soy formula if over 6 months old) during this period, breast milk can often still be tolerated or in some cases lactase drops may be prescribed to help breastfed babies to absorb the lactose from breastmilk 3-4
However, research continues on the potential for GLP-1s to become part of a new class of Alzheimers treatments, potentially complementing other approaches that target amyloid and tau proteins
They may affect digestion, mood, appetite, cost, and your relationship with food