Pharmacy information
Where your medication comes from.
More Tomorrows works with licensed US compounding pharmacies. Prescriptions are patient-specific and written by a licensed clinician, and we require our pharmacy partners to comply with applicable laws and compounding 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.
Federal framework
- Section 503A of the FD&C Act sets conditions a pharmacy must meet to compound under that section
- Compounded drugs are not FDA-approved and are not reviewed by FDA for safety or effectiveness
- FDA may inspect compounders and take action when conditions are not met
- Applicable USP compounding chapters are incorporated by statute and state law
State regulation
- Pharmacies are licensed by state boards of pharmacy
- Each state's pharmacy laws apply, including where the patient lives
- State inspections and oversight vary by state
- Pharmacist licensure, facility and equipment standards
Requirements
Key conditions under section 503A.
The ingredient, formulation, route of administration, pharmacy, patient need, and current federal and state requirements together determine whether a compounded prescription can be dispensed. Being listed in our catalog does not mean a product qualifies in every case.
Patient-specific prescriptions
A 503A compounder generally needs a valid prescription for an identified individual patient.
No large-scale manufacturing
503A pharmacies may not compound regularly or in inordinate amounts copies of commercially available drugs.
Interstate compliance
Shipping across state lines only where the pharmacy is licensed and state laws permit it.
Bulk drug substances
Bulk ingredients may be used only under specific statutory conditions: generally an applicable USP or NF monograph, a component of an FDA-approved drug product, or inclusion on the 503A bulks list, plus other requirements.
Sterile compounding
Sterile preparations, including injectables, are subject to applicable sterile compounding standards.
Records & quality control
Pharmacies maintain the records and quality controls required by applicable law.
What can be compounded
Why compounding is used.
Dosage forms
- Topical gels, creams, and ointments
- Capsules at specific strengths
- Sublingual tablets and troches
- Injectable 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
- Subject to cGMP requirements
Quality assurance
Standards we require of our partners.
Legal compliance
We require pharmacy partners to comply with applicable federal and state laws.
Compounding standards
We require compliance with applicable compounding standards, such as USP chapters for non-sterile and sterile preparations.
Licensure
Partners must hold the pharmacy licenses needed to dispense to a patient's state.
Patient-specific dispensing
Medications are dispensed only on a clinician's prescription for the individual patient.
Prescription required
Compounded medication starts with a clinician.
Compounded drugs are not FDA-approved products. They are prepared for an individual patient under a clinician's prescription when a commercially available product isn't appropriate.
Regulatory information changes. For current details, see the FDA's information on bulk drug substances used in compounding under section 503A.