Compounding Pharmacy Terms Clinic Teams Hear Most: A Plain-Language Glossary

Why a glossary

When a clinic or telehealth program starts working with a compounding pharmacy, the first conversations are full of terms that mean something precise to a pharmacist and not much to anyone else. This glossary covers the ones partners hear most from us, in plain words, with a link to the page that explains each one in more depth. It is grouped the way the terms come up: the rules, the ingredients and the preparation, the order flow, and quality and licensure.

The rules

503A pharmacy. A state-licensed pharmacy that compounds a preparation for one named patient, on a prescription from a licensed prescriber, under Section 503A of the federal Food, Drug, and Cosmetic Act. ProCompounding is a 503A pharmacy. Our page on what a 503A pharmacy is covers the rules in detail.

503B outsourcing facility. A facility registered under Section 503B that compounds larger batches without patient-specific prescriptions, under manufacturing-style requirements, for example for a clinic's office stock. A 503A pharmacy does not do that. Which one a program needs depends on how its patients get their medication; our guide to 503A and 503B for telehealth programs walks through the choice.

Patient-specific prescription. A prescription written for one named patient. It is the basis of everything a 503A pharmacy makes, and it is why a 503A pharmacy ships to the patient rather than stocking a clinic's shelf.

Office use, or office stock. Medication a clinic keeps on hand to give patients during visits. A 503A pharmacy does not supply it; that is what 503B outsourcing facilities are for.

Significant difference. When a commercially manufactured product with the same active ingredient exists, a 503A pharmacy may still compound a version for a patient if the prescriber identifies a change that makes a significant difference for that patient, such as a strength that is not made or an ingredient the patient cannot take. Our post on documenting a significant difference explains what to note on the prescription.

Essentially a copy. The other side of the same rule: a compounded preparation that duplicates a commercially available product with no patient-specific reason. Section 503A does not allow it, which is why the pharmacist will tell you which manufactured product exists and leave the next step to your prescriber.

Bulk drug substance, and the bulks list. A bulk drug substance is an active ingredient in raw form. Under 503A, a pharmacy may compound with it only if it meets a USP or NF monograph, is an ingredient of a commercially manufactured medicine, or appears on the federal 503A bulks list. Whether a molecule may be compounded at all is settled before anything else.

USP 795 and USP 800. Chapters of the United States Pharmacopeia. USP 795 sets the standards for non-sterile compounding: facilities, training, procedures, documentation and beyond-use dating. USP 800 sets the standards for handling hazardous drugs safely, for the people who make and handle them. We compound to both. Our page on hazardous drug compounding under USP 800 shows what that looks like in the lab.

Non-sterile compounding. Compounding of preparations such as creams, an olive oil base topical, capsules, tablets, nasal sprays and vaginal preparations under USP 795. ProCompounding is a non-sterile compounding pharmacy.

The ingredients and the preparation

API, meaning active pharmaceutical ingredient. The active ingredient itself, in raw form, before it is made into a preparation. Not to be confused with the other API, below. Every active pharmaceutical ingredient we use comes from a cGMP-compliant supplier and is checked before it is accepted into inventory.

cGMP. Current good manufacturing practice: the federal manufacturing standards an ingredient supplier works under. A pharmacy asks for ingredients made under cGMP, with the paperwork to show it.

Certificate of analysis, or CoA. The document a supplier sends with a lot of ingredient, recording the tests run on it and the results for identity, purity and potency. We check the certificate of analysis before a raw material is accepted into inventory. As Jessica Patrone, Pharm.D., our owner, wrote in her piece on peptide sourcing, a certificate of analysis is only as reliable as the source behind it. Our guide to vetting a peptide API supplier shows what a traceable one looks like.

Base, or vehicle. The cream, oil, gel or capsule filler that carries the active ingredient. The base decides how a preparation feels, how it is applied and what a patient with a sensitivity can tolerate. Our page on compounding dosage forms explains how our pharmacist chooses one.

Excipient. Any inactive ingredient: the base, fillers, dyes and preservatives. Excipients are where allergy and sensitivity requests live; our post on allergy notes on a compounded prescription covers what to write.

Dosage form. The physical form of the preparation: a hypoallergenic cream, an olive oil base topical, an oral capsule, a tablet, a nasal spray or a vaginal preparation, depending on the molecule. The prescriber writes the form on the prescription, and which forms suit which molecule is settled molecule by molecule.

Beyond-use date, or BUD. The date after which a compounded preparation should not be used, set by the pharmacist under USP 795 when the preparation is made. It is not the same as a manufacturer's expiration date, and it is one reason refills are timed the way they are. See our page on beyond-use dates and refill planning.

Potency testing. Laboratory testing that checks a preparation contains the amount of active ingredient it should. Potency testing is performed periodically through a third-party laboratory, depending on the preparation.

Formula development. The work of turning a program's intended preparation into a formula the pharmacy can make reliably: scheduled planning meetings with our formula development team ahead of launch, research and development against the program's protocols, and testing before release. Our post on developing a proprietary formulation for telehealth walks through it.

The order flow

E-prescribing. Sending a prescription electronically from the prescriber's EHR to the pharmacy. Search for ProCompounding Pharmacy, Johnson City, TN in your directory.

Provider portal. Our web portal, where a prescriber or clinic manages prescriptions and views order history.

API connection, the other API. In software, an application programming interface: a direct connection between your platform and our system, so prescriptions are sent automatically and status comes back to your system as each prescription progresses. Our page on telehealth pharmacy integrations explains the options.

Prescription transfer. Moving an existing prescription from one pharmacy to another. Many prescriptions can be transferred, some need a new prescription from the prescriber, and controlled medications follow stricter rules. Patients can start one on our prescription transfer page.

Compounding time. The time it takes to make a preparation once the prescription has been reviewed. We have a 48-hour compounding time on most preparations; shipping time is additional.

Formulary. The list of preparations a program prescribes: each molecule, strength, base and dosage form. We work out your formulary with you during onboarding, and our formulary catalog is shared once a clinic is onboarded.

Batch pricing. Pricing for a program's standard preparations. Batch pricing may be available for approved programs; your account manager confirms it.

Account manager. The one person on our side who owns your program after onboarding. Every ProCompounding partner has a dedicated account manager.

Quality and licensure

PCAB accreditation. Accreditation of a compounding pharmacy's practices by the Pharmacy Compounding Accreditation Board, administered by ACHC: procedures, training and quality systems, surveyed on site. Fewer than 1% of compounding pharmacies are PCAB accredited, and ProCompounding is one of them. Our page on PCAB accreditation explains what the survey looks at.

LegitScript certification. An independent review of pharmacies and other healthcare businesses that sell online. ProCompounding is LegitScript certified.

NABP Verified Pharmacy Program. An inspection of the pharmacy's practice site by the National Association of Boards of Pharmacy. Ours has been inspected.

Resident and non-resident pharmacy licenses. A pharmacy holds a resident license in its home state and a non-resident license in each other state it ships into. ProCompounding is licensed in all 50 states and the District of Columbia, with a resident pharmacy license in Tennessee, where we are based, and a non-resident license in every other state and D.C. Our 50-state pharmacy licensure checklist shows how to verify any pharmacy's licenses with each state board.

Board of pharmacy. The state agency that licenses pharmacies and pharmacists and sets each state's rules. The board in the patient's state matters as much as the board in the pharmacy's. Our guide to verifying a compounding pharmacy's license shows how to look one up.

White-label fulfillment. Shipping patients their prescriptions in packaging that carries the partner's brand. Partner-branded packaging, labels and marketing inserts are available, with the required prescription information on every label. Our white-label pharmacy fulfillment page covers what partner branding can include.

Common questions

What is the difference between a 503A pharmacy and a 503B outsourcing facility?

A 503A pharmacy compounds for one named patient on a prescription and ships to that patient. A 503B outsourcing facility compounds larger batches without patient-specific prescriptions, under manufacturing-style requirements, and supplies office stock. ProCompounding is a 503A pharmacy.

What does non-sterile compounding mean?

Compounding of preparations such as creams, an olive oil base topical, capsules, tablets, nasal sprays and vaginal preparations, under USP 795. ProCompounding is a non-sterile compounding pharmacy.

What is a beyond-use date on a compounded medication?

The date after which the preparation should not be used, set by the pharmacist under USP 795 when it is made. It is different from a manufacturer's expiration date.

What is a certificate of analysis?

The supplier's record of the tests run on a lot of ingredient and the results. We check it for identity, purity and potency before a raw material is accepted into inventory.

Does API mean the ingredient or the software connection?

Both, depending on who is talking. A pharmacist means the active pharmaceutical ingredient. A software team means the application programming interface that connects your platform to ours. In an onboarding conversation, ask which one.

What does patient-specific mean?

That the prescription and the preparation are for one named patient. It is the basis of 503A compounding and the reason a 503A pharmacy ships to the patient rather than stocking a clinic.

Working with ProCompounding

If a term you hear from us is not here, ask; that is what your account manager and our pharmacists are for. Our page on compounding fulfillment for telehealth clinics walks through how we work with partners, from formulary planning to your first shipment. When your team is ready, start clinic onboarding and tell us about your program.

This article is general information for clinics and is not legal or medical advice. Compounded preparations are not reviewed or approved by the FDA for safety or efficacy.