503A Pharmacy A traditional compounding pharmacy that prepares medications based on individual patient prescriptions. Subject to state pharmacy board oversight.
503B Outsourcing Facility An FDA-registered compounding facility that can produce larger batches without individual prescriptions. Subject to FDA CGMP requirements.
Bioavailability The percentage of an administered substance that reaches systemic circulation. Oral peptides typically have very low bioavailability due to degradation in the GI tract.
BPC-157 Body Protection Compound-157, a synthetic 15-amino-acid peptide derived from human gastric juice. FDA Category 2 (prohibited for compounding).
Category 1 FDA classification for bulk drug substances that may be used in compounding. Includes sermorelin, GHK-Cu (topical), VIP, and NAD+.
Category 2 Former FDA classification for substances prohibited from compounding due to safety concerns. Includes BPC-157, TB-500, and most popular peptides.
CGMP Current Good Manufacturing Practice. FDA regulations ensuring pharmaceutical quality, including facility standards, testing, and documentation.
COA (Certificate of Analysis) Laboratory documentation verifying a product's identity, purity, and quality. Should include HPLC, mass spectrometry, and for injectables, endotoxin testing.
DSHEA Dietary Supplement Health and Education Act of 1994. Defines dietary supplements and their regulatory framework. Most peptides do not qualify as dietary supplements under DSHEA.
Endotoxin Bacterial cell wall components (lipopolysaccharides) that can cause severe immune reactions. Critical safety concern for injectable products.
GLP-1 Glucagon-like peptide-1. A hormone that regulates blood sugar and appetite. Semaglutide and tirzepatide are GLP-1 receptor agonists.
Grey Market Products sold outside official distribution channels, often labeled 'for research use only.' Not illegal to sell in some contexts, but not approved for human use.
HPLC High-Performance Liquid Chromatography. Analytical technique used to measure peptide purity by separating compounds based on their chemical properties.
LAL Test Limulus Amebocyte Lysate test. The standard method for detecting bacterial endotoxins in injectable products.
Lyophilized Freeze-dried. Peptides are often sold as lyophilized powder for stability, requiring reconstitution with bacteriostatic water before use.
Mass Spectrometry Analytical technique that measures molecular weight to confirm peptide identity. Essential for verifying you have the correct compound.
NDIN New Dietary Ingredient Notification. Required submission to FDA before marketing a new dietary ingredient. No BPC-157 or similar peptide vendors have filed accepted NDINs.
PDA (Pentadeca Arginate) BPC-157 with arginine as the counter-ion instead of acetate. Marketed as a distinct compound but contains the identical peptide sequence.
Peptide A chain of amino acids linked by peptide bonds. Generally 2-50 amino acids; larger chains are typically called proteins.
Pharmacokinetics (PK) How the body absorbs, distributes, metabolizes, and eliminates a drug. Includes measurements like half-life and bioavailability.
RCT Randomized Controlled Trial. The gold standard for clinical evidence, where participants are randomly assigned to treatment or placebo groups.
SNAC Salcaprozate sodium. Absorption enhancer used in Rybelsus (oral semaglutide) to enable oral peptide bioavailability.
TB-500 A 7-amino-acid fragment of Thymosin Beta-4 commonly sold on the grey market. Not the same as full-length Thymosin Beta-4 used in research.
WADA World Anti-Doping Agency. Maintains the list of prohibited substances in sports. Most peptides including BPC-157 and TB-500 are prohibited.