Pharmaceutical Standards

Safety & Quality

Your health demands the highest standards. Every Pure Dose Labs product is compounded in FDA-registered facilities, prescribed by licensed providers, and tested for purity and potency.

503B

FDA-Registered

100%

Batch Tested

cGMP

Compliant

HIPAA

Protected

Our Pharmacy Partners

503B Compounding Pharmacy Partners

Pure Dose Labs partners exclusively with FDA-registered 503B outsourcing facilities—the highest tier of compounding pharmacies in the United States.

Section 503B of the Federal Food, Drug, and Cosmetic Act establishes strict requirements for outsourcing facilities, including registration with the FDA, regular inspections, and adherence to current Good Manufacturing Practices (cGMP).

FDA Registration & Inspection

Facilities must register with the FDA and undergo regular inspections

cGMP Compliance

Current Good Manufacturing Practices ensure consistent quality

Adverse Event Reporting

503B facilities must report adverse events to the FDA

503B vs Traditional Pharmacy

FDA Oversight Direct Registration
Manufacturing Standards cGMP Required
Batch Testing Every Batch
FDA Registered

Licensed Physicians

Board-certified providers

Health Evaluation

Comprehensive review

Valid Prescriptions

Clinically appropriate

Ongoing Monitoring

Continued care

Every prescription requires provider approval based on individual health assessment

Provider Network

Medical Oversight

Pure Dose Labs operates under a medical-directed model where licensed healthcare providers evaluate every patient before treatment begins.

This isn't a formality—it's a fundamental safeguard. Our providers review your complete health history, current medications, and wellness goals to determine if treatment is clinically appropriate for your individual situation.

The Medical Review Process:

  1. 1 Complete comprehensive health intake questionnaire
  2. 2 Licensed provider reviews medical history and contraindications
  3. 3 Provider determines clinical appropriateness
  4. 4 Prescription issued only when medically indicated
Quality Assurance

Sterility & Testing Protocols

Injectable medications demand absolute sterility and precise potency. Our pharmacy partners maintain rigorous quality control protocols that exceed industry standards.

Sterility Testing

Every batch tested per USP <797> and <800> standards to ensure sterile compounding

Potency Verification

HPLC testing confirms active ingredient concentration matches label claims

Endotoxin Testing

LAL testing ensures products are free from bacterial endotoxins

Purity Analysis

Mass spectrometry confirms identity and detects any impurities or contaminants

Testing Standards

Sterility USP <797>

Compounded under ISO Class 5 cleanroom conditions with full gowning protocols

Potency HPLC Verified

High-performance liquid chromatography confirms exact concentration

Identity Mass Spec

Mass spectrometry validates molecular identity of active compounds

Endotoxin LAL Testing

Limulus amebocyte lysate assay ensures freedom from pyrogens

Cold Chain Shipping

Temperature-controlled from pharmacy to patient

1

Pharmacy Storage

Refrigerated at 2-8°C until shipment

2

Insulated Packaging

Gel packs maintain temperature during transit

3

Express Delivery

Priority shipping minimizes transit time

Patient Receives

Product arrives cold, ready for refrigeration

2-8°C
Logistics

Cold Chain Shipping

Peptides and injectable medications are temperature-sensitive. Improper storage can degrade potency and compromise safety. Our shipping protocols ensure your medication arrives in optimal condition.

Insulated Packaging

Medical-grade thermal packaging with gel packs maintains 2-8°C throughout transit

Priority Shipping

Express delivery minimizes time in transit and reduces temperature exposure risk

Discreet Packaging

Unmarked exterior packaging protects your privacy with no indication of contents

Upon arrival: Refrigerate your medication immediately at 2-8°C (36-46°F). Do not freeze. Follow storage instructions included with your order.

Resources

Patient Education

Informed patients achieve better outcomes. We provide comprehensive resources to support your treatment journey.

Administration Guides

Step-by-step instructions for safe and proper injection technique, including reconstitution procedures for lyophilized peptides.

  • Subcutaneous injection technique
  • Reconstitution instructions
  • Dosing calculators

Storage Guidelines

Proper storage is essential for maintaining medication efficacy. Learn how to store your peptides correctly.

  • Temperature requirements
  • Light protection guidance
  • Shelf life information

Safety Information

Understanding potential side effects, contraindications, and when to seek medical attention.

  • Side effect profiles
  • Drug interaction warnings
  • Emergency protocols

Product Monographs

Detailed clinical information about each peptide, including mechanism of action and clinical evidence.

  • Pharmacology overview
  • Clinical study summaries
  • References & citations

Patient Support

Our support team is available to answer questions and connect you with medical providers when needed.

  • Email support response
  • Provider consultation access
  • Order tracking assistance

Safe Disposal

Guidance on properly disposing of needles, syringes, and unused medication in compliance with regulations.

  • Sharps container guidance
  • Local disposal resources
  • Environmental safety

Your Safety Is Our Standard

Experience the difference that pharmaceutical-grade quality and proper medical oversight can make in your wellness journey.

503B
Compounded

Medical
Oversight

Third-Party
Tested

HIPAA
Compliant

Cold Chain
Shipping