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Comparisons

Compounding comparisons, side by side

USPeptideRx EditorialLast reviewed:

Most of the confusion in compounding procurement is two things wearing one name. A prescription delivered to your office is not office stock. A compounded preparation is not a generic. A facility registered with FDA as an outsourcing facility is not a drug manufacturer, though several states license it as one. Each page here takes one of those pairs and names the single fact that separates them, quoting the rule that draws the line.

How these pages are organised

By what is being told apart, and at what level.

The three below sit at three different levels deliberately: one compares two transactions, one compares two regulatory objects, and one compares two entities. That is why they can each be read alone without repeating the others — and it is the test a new page has to pass before it joins them. Two pages comparing the same two things are one page, so this family will never hold a second comparison of a pairing it already covers.

Each comparison and the distinction it draws. Reviewed 2026-08-29.
ComparisonWhat separates the two
A 503B outsourcing facility vs a drug manufacturerTwo entities, told apart by what reaches the market rather than by how carefully it was made.
Compounded vs commercially availableTwo regulatory objects, told apart by whether an application was reviewed and approved before marketing.
Office stock vs patient-specific fulfilmentTwo transactions, told apart by whether a patient is named before the preparation is released.

The comparison that is not in this list

The one most readers want first, and it lives at 503A pharmacies and 503B outsourcing facilities compared.

It sits outside this family for a reason that has nothing to do with what it says: it is the most-linked page in this section, it was published at that address before the family existed, and moving a page that other pages depend on is a job worth doing deliberately rather than in passing. It is the canonical comparison of the two pathways, every page here links to it, and it is where to start if you do not yet know which pathway a supplier is quoting you under.

What all of them turn on

One distinction, appearing at three different levels.

21 U.S.C. § 353a exempts a compounded drug from current good manufacturing practice, adequate directions for use and new drug approval where it is “compounded for an identified individual patient based on the receipt of a valid prescription order.” Section 353b is the provision written for the case where no patient is named, and it exempts a registered outsourcing facility from two of those three — not from the manufacturing-practice requirement. Almost every distinction on these pages is a consequence of which of those two provisions the item was made under, and of the fact that neither of them involves a pre-market review.

What a comparison page here will never do

Rank anything, or recommend anyone.

No pharmacy, outsourcing facility or supplier is named, rated or ranked on any page in this family, and USPeptideRx is not compared against anything. These pages compare categories defined by rule — a transaction against a transaction, an object against an object — because that is the comparison a reader can check against a primary source, and it is the only kind we are in a position to make honestly.

Where to start

With the level your question is actually on. If you are deciding what to put on an order, the transaction comparison is the one. If you are deciding whether a preparation may be made at all while an approved product exists, it is the object comparison. If you are assessing a supplier and its state credentials do not match its federal ones, it is the entity comparison.

If you would rather have your state, your practice type and your intended preparations sorted into these categories directly, you can apply for an account.

What this page does not establish

  • These pages compare categories, not products and not suppliers. Nothing here says whether any particular substance may be compounded, or whether any particular facility is compliant.
  • The states named on the member pages are those read in full from primary sources: Georgia, North Carolina, Ohio, Louisiana, New Jersey, Illinois, Texas, Florida, California, New York, Arizona and Colorado. A state not named is unknown to us rather than permissive.
  • Educational information, not legal advice. Verify with your own counsel and your state board before you order.
  • Nothing here describes any drug’s safety or effectiveness.

Sources

Primary sources, fetched directly from the issuing body. No secondary summaries.

  1. [1]21 U.S.C. § 353a — Pharmacy compounding (Cornell LII)
  2. [2]21 U.S.C. § 353b — Outsourcing facilities (Cornell LII)
  3. [3]FDA — Human drug compounding: the laws and regulations