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Telehealth and 503A compounding glossary

Short definitions of the terms you will meet when building a compounded care brand, each linked to the longer explanation.

503A pharmacy

A state-licensed pharmacy that compounds drugs for an identified patient on a valid prescription, under section 503A of the Federal Food, Drug, and Cosmetic Act. Read more

503B outsourcing facility

A compounder that registers voluntarily with FDA, follows CGMP, is inspected on a risk-based schedule, and can supply healthcare providers without a patient-specific prescription. Read more

Anticipatory compounding

Compounding limited quantities before a prescription arrives, based on a history of valid prescriptions. Under FDA guidance a 503A compounder may hold no more than a 30-day supply. Read more

Asynchronous visit

A telehealth encounter where the patient and prescriber do not talk in real time, such as a reviewed questionnaire. Some states restrict its use for some care. Read more

Bulk drug substance

An active ingredient used in compounding. Under section 503A it must meet a USP or NF monograph, be a component of an FDA-approved drug, or appear on FDA’s 503A bulks list. Read more

CGMP

Current good manufacturing practice: FDA’s quality requirements for drug manufacturing. 503B facilities must meet them, and 503A pharmacies are exempt. Read more

Clinical review

A recorded decision by a person that a compounded order may proceed to a pharmacy. On SourceRX, no compounded order is sent to a pharmacy without one. Read more

Compounding

Combining, mixing or altering ingredients to make a medication for a patient, often one who cannot be treated with an FDA-approved drug. Compounded drugs are not FDA-approved. Read more

Corporate practice of medicine

A doctrine in many states that restricts who may own a medical practice or employ physicians. It often shapes how a non-physician founder structures a telehealth company. Read more

Hosted checkout

A payment page run by the card processor, so card numbers never reach the merchant’s own servers. This narrows the merchant’s PCI scope. Read more

Interstate Medical Licensure Compact

An agreement among member states giving qualified physicians a voluntary, expedited pathway to licenses in multiple states. Each state still issues its own license. Read more

National Provider Identifier (NPI)

A unique 10-digit number for US healthcare providers. An NPI identifies a provider and does not show state licensure. Read more

Nonresident pharmacy license

A license or registration many states require before an out-of-state pharmacy can ship medication to patients there. Read more

NPPES

The National Plan and Provider Enumeration System, the CMS registry that issues NPIs and publishes who holds them. Read more

Office-use prescription

An order for stock kept at a practice instead of for a named patient. It does not meet the patient-specific requirement of section 503A. Read more

Patient-specific prescription

A valid prescription order that identifies the individual patient the drug is for. Section 503A depends on it. Read more

State board of pharmacy

The state agency that licenses pharmacies and pharmacists. It holds primary day-to-day oversight of 503A pharmacies. Read more

White-label telehealth

A model where a business sells care under its own brand while a platform runs prescribers, pharmacy fulfillment, patient records and payments. Read more

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