Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act | Guideline Explorer

Description

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a final guidance for industry entitled “Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” This guidance describes policies that FDA intends to use in evaluating bulk drug substances nominated for use in compounding under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for inclusion on the list of bulk drug substances that can be used in compounding under section 503B.

Scope & Applicability

Product Classes

2

Biological products

development program for drug and biological products

FDA-approved drug product

reference product for clinical need evaluation; Evaluation of whether a nominated substance is a component of an approved drug

Stakeholders

2

outsourcing facility

Facilities registered under section 503B that compound human drug products; entities that compound drugs under section 503B; Entities that compound drug products under section 503B

outsourcing facilities

Facilities registered under section 503B; Entities reporting adverse events under Section 503B.

Regulatory Context

Attributes

5

clinical need

Standard for including a substance on the 503B bulks list

Physical and chemical characterization

Factor used to evaluate clinical need for a bulk drug substance

stability

factor in physical and chemical characterization

purity

Key tests for vaccine purity should be validated

dosage form

The physical form of the drug product.

Identified Hazards

Hazards

2

Safety risks

Risks associated with handling products subject to REMS with ETASU.

Safety issues

Safety concerns raised by the use of the substance in compounding

Related CFR Sections (3)

21CFR207.1§ 207.1 What definitions and interpretations of terms apply to this part?
The definitions and interpretations of terms in sections 201 and 510 of the Federal Food, Drug, and Cosmetic Act apply to the terms used in this part, if not otherwise defined in this section. The following definitions apply to this part:Read full regulation →
21CFR207.3§ 207.3 Bulk drug substance.
Bulk drug substance, as referenced in sections 503A(b)(1)(A) and 503B(a)(2) of the Federal Food, Drug, and Cosmetic Act, previously defined in § 207.3(a)(4) , means the same as “active pharmaceutical ingredient” as defined in § 207.1 .Read full regulation →
21CFR10.30§ 10.30 Citizen petition.
(a) This section applies to any petition submitted by a person (including a person who is not a citizen of the United States) except to the extent that other sections of this chapter apply different requirements to a particular matter.Read full regulation →

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