CPG Sec. 410.100 *Finished Dosage Form Drug Products in Bulk Containers - Applications of Current Good Manufacturing Practice Regulations*

Description

*Questions have arisen concerning the application of the "umbrella" CGMP regulations, 21 CFR Parts 210 and 211 to firms which prepare dosage form drug products in bulk containers, such as tablets in fiber drums, and sterile antibiotic powders in bulk containers. Drug products in such bulk quantities are usually intended for further repacking into conventional retail packages such as bottles of 100 tablets each or vials of an antibiotic powder for reconstitution. These questions of application have, on occasion mistakenly expanded the term "bulk drug" to mean not only ingredients of drug products but also finished dosage forms in large quantities. However, in order to apply Parts 210 and 211 it is important to distinguish drug products in finished dosage forms in bulk containers from bulk drug components (i.e. ingredients intended for use in manufacturing or processing of a drug product.)*

Scope & Applicability

• 21CFR211.3§ 211.3 Definitions.

  The definitions set forth in § 210.3 of this chapter apply in this part.Read full regulation →

• 21CFR210.3§ 210.3 Definitions.

  (a) The definitions and interpretations contained in section 201 of the act shall be applicable to such terms when used in this part and in parts 211 , 225 , and 226 of this chapter .Read full regulation →

• CGMP/Finished Pharmaceuticals/Adulterated

  SV Labs Corporation

  2025-12-23

• CGMP/Finished Pharmaceuticals/Adulterated

  Guangdong Renhe Guozhuang Biotechnology Co., Ltd.

  2025-12-23

• CGMP/Finished Pharmaceuticals/Adulterated

  Medinatura New Mexico, Inc.

  2025-12-23

• CGMP/Finished Pharmaceuticals/Adulterated

  Sklar Personal Care Inc.

  2025-12-16

• CGMP/Deviations/Biologics License Application (BLA)

  Microvascular Tissue, Inc.

  2025-12-16

• CGMP/Finished Pharmaceuticals/Adulterated

  Catalent Indiana, LLC

  2025-12-11

• CGMP/Finished Pharmaceuticals/Adulterated

  DeVere Manufacturing Inc.

  2025-12-09

• CGMP/Finished Pharmaceuticals/Adulterated

  CDL Services, Inc. DBA Technichem

  2025-12-09

• CGMP/Finished Pharmaceuticals/Adulterated

  Seaway Pharma Inc.

  2025-12-09

• Compounding Pharmacy/Adulterated Drug Products

  PQ Pharmacy, LLC

  2025-12-02

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