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WhiteLabel Compounds manufactures active pharmaceutical ingredients, also called bulk drug substances, at its plant. Made in USA. We supply [Account types] with a certificate of analysis for each lot and a dated regulatory status line for each substance.
Under section 503A of the Federal Food, Drug, and Cosmetic Act, a bulk drug substance used in compounding must come from an FDA-registered establishment and arrive with a valid certificate of analysis. The substance must also have a USP or NF monograph, be a component of an FDA-approved drug, or appear on FDA's 503A bulks list. We state which applies on every product page.
Each product page carries one dated line.
Regulatory statusComponent of an FDA-approved drug. Supplied for use under section 503A. Checked [date].
Regulatory statusRecommended by FDA's Pharmacy Compounding Advisory Committee in July 2026. Not on the 503A bulks list as of [date].
Regulatory statusNo current basis for use in human drug compounding. Not offered to pharmacies. Checked [date].
An active pharmaceutical ingredient, also called a bulk drug substance, is the substance intended to become the active part of a finished drug. It is sold by weight to businesses that make finished products.
A 503A pharmacy compounds for an identified patient on a prescription, under a state pharmacy license. A 503B outsourcing facility registers with FDA, follows cGMP and can compound sterile drugs without patient-specific prescriptions. Each has its own rules on which bulk substances it may use.
Three things under federal law. The supplier must be an FDA-registered establishment. Each lot must come with a valid certificate of analysis. The substance must have a USP or NF monograph, be a component of an FDA-approved drug, or be on FDA's 503A bulks list.
A peptide can be compounded if it has a USP or NF monograph, is a component of an FDA-approved drug, or is on FDA's 503A bulks list. [Dated status sentence to be supplied.] FDA's own list is the authority.
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Tell us about the peptide line you want to bring to market. Request a tailored proposal for capsules, tablets, sublingual strips, buccal strips or another format, including packaging, quantities, pricing and production timing.