Peptide Resources and Reference Links
Curated links to the primary databases, verification tools, and reference materials used throughout this site. All links point to official government or recognized third-party sources.
FDA Databases and Tools
Search for FDA-approved drug products by active ingredient, brand name, or application number. Shows approval history, labeling, and review documents.
Approved drug products with therapeutic equivalence evaluations. Lists patent and exclusivity information for approved drugs.
Official FDA-approved prescribing information (package inserts) for marketed drugs. Maintained by the National Library of Medicine.
Current and resolved drug shortages. Critical for understanding whether compounded versions of a drug may be legally produced.
Searchable database of FDA warning letters issued to companies for regulatory violations.
List of registered 503B outsourcing facilities. Verify whether a compounding facility is FDA-registered.
Clinical Evidence
Registry of clinical studies. Search by drug name to see what clinical trials have been conducted or are in progress.
Biomedical literature database maintained by the National Library of Medicine. Search for peer-reviewed studies on peptide safety and efficacy.
Pharmacy Verification
Verify pharmacy licenses and check for disciplinary actions. Offers the VIPPS accreditation program for online pharmacies.
Third-party verification service for pharmacies, telehealth providers, and supplement companies. Helps identify rogue operators.
Glossary of Key Terms
- Peptide
- A short chain of amino acids (typically 2 to 50) linked by peptide bonds. Smaller than proteins and used in many therapeutic applications.
- GLP-1 (Glucagon-Like Peptide-1)
- An incretin hormone that stimulates insulin secretion, slows gastric emptying, and reduces appetite. The target of drugs like semaglutide and tirzepatide.
- NDA (New Drug Application)
- The formal application submitted to the FDA requesting approval to market a new drug. Contains data from preclinical and clinical studies.
- BLA (Biologics License Application)
- The application submitted to the FDA for approval of biologic products, including some peptide drugs.
- IND (Investigational New Drug)
- An application that allows an investigational drug to be shipped across state lines for use in clinical trials. An IND is not approval for marketing.
- 503A Pharmacy
- A state-licensed compounding pharmacy that prepares drugs based on patient-specific prescriptions under section 503A of the Federal Food, Drug, and Cosmetic Act.
- 503B Outsourcing Facility
- An FDA-registered compounding facility that may produce drugs without patient-specific prescriptions, subject to cGMP standards and FDA inspection.
- Compounding
- The practice of creating customized drug preparations to meet specific patient needs not served by commercially available products.
- Off-Label Use
- The use of an FDA-approved drug for an indication, dosage, or patient population not specified in the drug's approved labeling. Legal when prescribed by a licensed physician.
- GMP (Good Manufacturing Practice)
- FDA regulations that govern the manufacturing, processing, and packaging of drugs to ensure quality and safety.
- cGMP (Current Good Manufacturing Practice)
- The current standards for GMP, which evolve as technology and practices improve. 503B facilities must meet cGMP requirements.
- Essentially a Copy
- A compounded drug that is identical or nearly identical in active ingredient, dosage form, strength, and route of administration to a commercially available drug. Generally prohibited unless the commercial drug is in shortage.
- Drug Shortage
- A period when the supply of an FDA-approved drug is insufficient to meet demand. Listed on the FDA Drug Shortages database and may permit compounding of otherwise restricted products.
- USP (United States Pharmacopeia)
- An independent organization that sets quality standards for drugs, including compounding standards (USP <795> for non-sterile, USP <797> for sterile preparations).
- Biosimilar
- A biologic product that is highly similar to an already-approved biologic (reference product) with no clinically meaningful differences. Approved through an abbreviated pathway.