Description
This document is intended to provide guidance on general principles for submitting information on packaging materials used for human drugs and biologics. This guidance supersedes the FDA Guideline for Submitting Documentation for Packaging for Human Drugs and Biologics, issued in February 1987 and the packaging policy statement issued in a letter to industry dated June 30, 1995 from the Office of Generic Drugs. This guidance is not intended to describe the information that should be provided about packaging operations associated with drug product manufacture.
Scope & Applicability
Product Classes
10Specific dosage form category requiring packaging documentation; Requires batch-to-batch monitoring of extraction profiles; products where COA acceptance may not be appropriate; intended for respiratory-tract compromised patients
Also known as DPI; inhalation powders intended for local or systemic effect.; DPI products also consist of a drug formulation and a container closure system.; DPI drug products quality considerations; DPIs drug products quality considerations; Drug product requiring specific quality controls; Information to be Submitted in Support of an Application for a DPI; Labeling requirements for oral and nasal DPIs; DPI product should only be used with the device constituent part provided; DPI performance
Also known as MDI; inhalation aerosols intended for local or systemic effect.; MDI products consist of a drug formulation and a container closure system.; MDI drug products quality considerations; MDIs drug products quality considerations; Drug product requiring specific quality controls; Information to be Submitted in Support of an Application for an MDI; Instructions for patient use of the MDI; General Relationship Between QTPP Elements and CQAs for MDIs; MDI products used with a spacer or hol
Guidance provides a framework for over-the-counter drug products.
Dosage form where indirect food additive regulations alone are not recommended for safety evidence
delivery system held in place in the uterus
delivery system applied to skin with adhesive
self-contained dosage forms like transdermal, ocular, and intrauterine systems
Subject of the guidance, including liquid-based and semisolid products applied to skin or membranes.; Subject of the characterization guidance for ANDAs
elixirs, emulsions, extracts, fluid extracts, solutions, gels, syrups; products taken for extended periods or chronic drug regimens
Stakeholders
5A facility that packages food for a fee.
new facilities added by the DMF holder
Entity submitting development data and knowledge; Entity performing the work process for change
manufacturer of a packaging component
Trading partner required to have verification systems; Trading partner required to have verification systems in place.; Trading partner required to validate transaction history and verify product identifiers; must quarantine illegitimate product; receives returned product that it intends to further distribute
Regulatory Context
Attributes
5indicating the package is not child-resistant
property that solid oral dosage forms must be protected against
required attribute for injectables and ophthalmics
A property of a container evaluated using USP <661>.
closure requirement under 21 CFR 211.132
Identified Hazards
Hazards
3risk in multidose drug products
result from the presence of impurities
Sponsor should also provide a safety evaluation of any extractables
Related CFR Sections (14)
- 21CFR310.509§ 310.509 Parenteral drug products in plastic containers.
(a) Any parenteral drug product packaged in a plastic immediate container is not generally recognized as safe and effective, is a new drug within the meaning of section 201(p) of the act, and requires an approved new drug application as a condition for marketing. An “Investigational New Drug ApplicaRead full regulation →
- 21CFR600.11§ 600.11 Physical establishment, equipment, animals, and care.
(a) Work areas. All rooms and work areas where products are manufactured or stored shall be kept orderly, clean, and free of dirt, dust, vermin and objects not required for manufacturing. Precautions shall be taken to avoid clogging and back-siphonage of drainage systems. Precautions shall be taken Read full regulation →
- 21CFR310.3§ 310.3 Definitions and interpretations.
As used in this part:Read full regulation →
- 21CFR211.94§ 211.94 Drug product containers and closures.
(a) Drug product containers and closures shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug beyond the official or established requirements.Read full regulation →
- 21CFR211.65§ 211.65 Equipment construction.
(a) Equipment shall be constructed so that surfaces that contact components, in-process materials, or drug products shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requiremenRead full regulation →
- 21CFR314.420§ 314.420 Drug master files.
(a) A drug master file is a submission of information to the Food and Drug Administration by a person (the drug master file holder) who intends it to be used for one of the following purposes: To permit the holder to incorporate the information by reference when the holder submits an investigationalRead full regulation →
- 21CFR314.70§ 314.70 Supplements and other changes to an approved NDA.
(a) Changes to an approved NDA.Read full regulation →
- 21CFR200.50§ 200.50 Ophthalmic preparations and dispensers.
- 21CFR211.84§ 211.84 Testing and approval or rejection of components, drug product containers, and closures.
(a) Each lot of components, drug product containers, and closures shall be withheld from use until the lot has been sampled, tested, or examined, as appropriate, and released for use by the quality control unit.Read full regulation →
- 21CFR211.122§ 211.122 Materials examination and usage criteria.
(a) There shall be written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling, examination, and/or testing of labeling and packaging materials; such written procedures shall be followed. Labeling and packaging materials shall be representatively samplRead full regulation →
- 21CFR211.22§ 211.22 Responsibilities of quality control unit.
(a) There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products, and the authority to review production records to assure that no eRead full regulation →
- 21CFR601.12§ 601.12 Changes to an approved application.
(a) General.Read full regulation →
- 21CFR600.3§ 600.3 Definitions.
As used in this subchapter:Read full regulation →
- 21CFR211.132§ 211.132 Tamper-evident packaging requirements for over-the-counter (OTC) human drug products.
(a) General. The Food and Drug Administration has the authority under the Federal Food, Drug, and Cosmetic Act (the act) to establish a uniform national requirement for tamper-evident packaging of OTC drug products that will improve the security of OTC drug packaging and help assure the safety and eRead full regulation →
Related Warning Letters (10)
- 2025-12-23
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.
- 2025-12-16
CGMP/Finished Pharmaceuticals/Adulterated
Sklar Personal Care Inc.
- 2025-12-16
CGMP/Deviations/Biologics License Application (BLA)
Microvascular Tissue, Inc.
- 2025-12-11
CGMP/Finished Pharmaceuticals/Adulterated
Catalent Indiana, LLC
- 2025-12-09
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.
- 2025-12-02
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PQ Pharmacy, LLC
See Also (8)
- Completeness Assessments for Type II API DMFs Under GDUFA Guidance for Industry: Guidance for Industry (Status: Final)
- Geriatric Information in Human Prescription Drug and Biological Product Labeling Guidance for Industry: Draft Guidance for Industry (Status: Draft)
- Annual Reportable Labeling Changes for New Drug Applications and Abbreviated New Drug Applications for Nonprescription Drug Products (Status: Draft)
- Guidance for Industry: Preparation of Premarket Submissions for Food Contact Substances (Chemistry Recommendations) (Status: Final)
- Guidance for Industry: Preparation of Food Contact Substance Notifications (Toxicology Recommendations) (Status: Final)
- Guidance for Industry: Preparation of Food Contact Substance Notifications (Administrative) (Status: Final)
- CVM GFI #292 Chemistry, Manufacturing, and Controls Considerations for Type A Medicated Articles (Status: Draft)
- Nuclear Pharmacy Guideline Criteria for Determining When to Register as a Drug Establishment (Status: Final)