Pharmacy information
Where your medication comes from.
More Tomorrows works exclusively with licensed US 503A compounding pharmacies. Every prescription is patient-specific, physician-written, and filled to USP standards.
The basics
What is a 503A pharmacy?
A 503A pharmacy — a traditional compounding pharmacy — is a licensed pharmacy that compounds medications on a patient-specific basis, from a prescription written by a licensed practitioner. These pharmacies operate under Section 503A of the Federal Food, Drug, and Cosmetic Act, established by the Drug Quality and Security Act of 2013. They make personalized medications that either aren't commercially available or need to be customized for an individual patient's needs.
Regulatory framework
Two layers of oversight.
FDA oversight
- Regulated under Section 503A of the FD&C Act
- Subject to FDA inspection and enforcement
- Adverse event reporting requirements
- Compliance with USP compounding standards
State regulation
- Licensed by state boards of pharmacy
- Compliance with each state's pharmacy laws
- Regular state inspections
- Pharmacist licensure, facility and equipment standards
Requirements
Rules a 503A pharmacy must follow.
Patient-specific prescriptions
Compounding only pursuant to a prescription written for you by a licensed practitioner.
No large-scale manufacturing
503A pharmacies cannot mass-produce for distribution without patient-specific prescriptions.
Interstate compliance
Shipping across state lines only where both states' laws permit it.
Approved substances
FDA-approved drugs or bulk substances from the FDA's bulk drug substances list.
Sterile compounding
USP <797> standards for all sterile preparations, including injectables.
Records & quality control
Documented quality assurance, testing, and records for every compounding activity.
What can be compounded
Types of compounded medications.
Hormone therapy
- Bioidentical estradiol, progesterone, testosterone
- Thyroid formulations
- Growth hormone secretagogues and peptides
- Custom strengths and dosage forms
Specialized formulations
- Topical gels, creams, and ointments
- Capsules at specific dosages
- Sublingual tablets and troches
- Injectable preparations
Wellness & longevity
- NAD+ and peptide therapies
- Vitamin and mineral injections
- Antioxidant formulations
- Immune support preparations
Personalization
- Allergen and filler removal
- Alternative delivery methods
- Combination formulations
- Strengths not commercially available
Comparison
503A vs. 503B.
503A — traditional compounding
- Patient-specific prescription required
- State-licensed and regulated
- Lower-volume, individualized production
- Direct patient relationship
- More flexible formulation options
503B — outsourcing facility
- Can produce without patient-specific prescriptions
- FDA-registered facilities
- Higher-volume manufacturing
- Supplies hospitals and clinics
- More stringent cGMP requirements
Quality assurance
Standards we require of our partners.
USP standards
Compliance with USP <795> for non-sterile and <797> for sterile compounding.
Environmental controls
Controlled temperature, humidity, and air quality in all compounding areas.
Personnel training
Formal, ongoing training programs for every member of compounding staff.
Equipment calibration
Scheduled calibration and maintenance of all compounding equipment.
Prescription required
Compounded medication starts with a clinician.
Compounded drugs are not FDA-approved products. They are prepared for an individual patient under a physician's prescription when a commercially available product isn't appropriate.