Clear answers for the path ahead

The website provides separate pathways for licensed prescribers and practices, pharmacies and facility buyers, patients seeking general support, and existing business partners. Each pathway presents the information and next steps most relevant to that relationship.

Begin with how the medication will be prescribed, purchased, and used. The 503A pathway generally supports patient-specific prescriptions for identified individual patients. The 503B pathway supports qualified pharmacy, clinic, hospital, and facility buyers through an outsourcing-facility model. The 503A vs 503B comparison page provides a more detailed overview.

A new provider or practice should complete the Practice Enrollment form. The form collects professional and business information needed for an initial review without requesting patient-specific information. Submission begins the enrollment process but does not automatically approve or activate an account.

Existing customers should use their established account-support channel whenever possible, especially for active prescriptions, orders, refills, shipment questions, or time-sensitive operational issues. The general contact form can also be used when the correct support channel is unclear.

Section 503A generally applies to patient-specific compounding performed by a licensed pharmacist in a state-licensed pharmacy or federal facility, or by a licensed physician, when the applicable statutory conditions are met. The process is centered on a valid prescription for an identified individual patient.

A licensed prescriber may discuss patient-specific needs such as strength, dosage form, ingredient considerations, or administration requirements with the pharmacy. Availability depends on the prescription, formulation, applicable law, ingredient eligibility, pharmacy capabilities, and the patient and prescriber states.

No. This website is not a patient portal and does not offer direct-to-consumer online ordering. Patient-specific medications require an appropriate prescription and must move through the pharmacy's established prescribing and dispensing workflow.

No. The enrollment form begins an initial review. Account setup and service availability remain subject to licensure, professional verification, required documentation, product scope, state requirements, and any other applicable onboarding conditions.

A 503B outsourcing facility is an establishment that registers with FDA and compounds sterile drugs under the direct supervision of a licensed pharmacist. Qualifying outsourcing-facility products and operations are subject to applicable federal requirements, including current Good Manufacturing Practice requirements and FDA inspection.

A 503B outsourcing facility may compound with or without prescriptions for identified individual patients, subject to the conditions and limitations of section 503B and other applicable federal and state requirements.

The pathway is intended for permitted healthcare buyers such as pharmacies, hospitals, clinics, and other qualified facilities. Buyer eligibility, licensure, documentation, intended use, receiving state, and product availability must be reviewed before ordering begins.

The review may include facility or pharmacy licensure, purchaser information, shipping location, intended ordering model, product needs, and other documentation relevant to the account. The exact requirements depend on the buyer type, state, product, and applicable operational framework.

No. Coverage differs by service pathway, entity, license type, product category, prescriber or buyer location, controlled-substance status, and current operating authority. Review the Licensing & Compliance page for a directional overview and contact the team to confirm a specific request.

No. Compounded drugs are not FDA-approved, which means FDA does not conduct premarket review of each compounded drug for safety, effectiveness, or quality. Facility registration, pharmacy licensure, inspection, or compliance with a compounding pathway should not be described as FDA approval of a compounded product.

Documentation may include certificates of analysis, ingredient or supplier records, lot-specific release information, storage guidance, or laboratory testing such as potency, sterility, or endotoxin testing when applicable. Availability and testing requirements vary by formulation, batch, pathway, and release plan.

A beyond-use date is the date or time after which a compounded preparation should not be used. It is assigned using applicable compounding standards, preparation characteristics, storage conditions, and available scientific information. A beyond-use date is not the same as a manufacturer expiration date.

No. State licensure is only one part of the review. Final availability may also depend on the service pathway, formulation, sterile or nonsterile scope, controlled-substance authority, prescriber or buyer eligibility, intended use, and current product status.

Yes, for general routing or non-urgent support questions. Patients should not include prescription numbers, diagnoses, dates of birth, insurance details, medication histories, or other patient-specific information. Questions tied to an active prescription or shipment should use the established pharmacy support channel whenever possible.

No. Do not submit patient names, diagnoses, prescription details, dates of birth, insurance information, medical records, or other protected health information through public website forms. Patient information should be transmitted only through an approved secure workflow.

No. Website content is provided for general informational purposes and does not diagnose, treat, prescribe, or replace consultation with a licensed healthcare professional. Treatment decisions should be made between a patient and an appropriately licensed provider.

The inquiry type and information provided are used to direct the message to the most appropriate team, such as general support, provider onboarding, existing-account support, or pharmacy and facility partnerships. Avoid including patient-specific medical information in the message.