A brief presentation on the Code of Federal Regulations
Covers the following aspects -
- What is CFR?
-History of CFR
- CFR Title 21
- CFR in modern times.
- Research tools in CFR
DRUG MASTER FILE
Presented by :
RUSHIKESH D MENDHE
Roll no - 511
Mpharm Ist Year
(Department of Pharmaceutics)
Content : :
INTRODUCTION
TYPES OF DMF
DMF FORMAT & ASSEMBLY
DELIVERY OF DMF TO FDA
SUBMISSION OF DMF
THE MECHANISM OF A DRUG MASTER FILE
CTD & ELECTRONIC DMFS
UPDATES TO DMF
CLOSURE OF A DRUG MASTER FILE
APPLICATION OF DMF
REFERENCE
INTRODUCTION :
A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.
This guideline does not impose mandatory requirements.
Objectives :
Main Objective of the DMF is to support regulatory requirements
To prove the quality, safety and efficacy of the medicinal product
TYPES OF DMF :
DMF FORMAT & ASSEMBLY :
The DMF is submitted as Original and Duplicate jackets, collated, assembled, paginated, and jacketed, using covers obtained from the government printing office and a respecifically provided for the DMFs
Multiple volumes are numbered, and the paper must be standard paper size
Paper length should not be less than 10 inches nor more than 12 inches.
Each volume of a DMF should be not more than 2 inches thick
DELIVERY OF DMF TO FDA :
DMF should be submitted at following address :
Food and Drug Administration Center for Drug Evaluation and Research Central Document Room 5901 – B Ammendale Road Beltsville, MARYLAND 20705-1266 USA
SUBMISSION OF DMF :
The DMF must be submitted in two copies, one with a blue cover and one with a red cover.
Each page of each copy of the DMF should be dated and consecutively numbered.
Each DMF submission should contain :
• A Transmittal letter
• Administrative information about the submission
• Other specific information
A. Transmittal Letter :
i) Original Submissions :
• Identification of submission: Original, the type of DMF as classified in Section III, and its subject.
• Identification of the applications, if known, that the DMF is intended to support, including the name and address of each sponsor, applicant, or holder, and all relevant document numbers.
• Signature of the holder or the authorized representative.
• Typewritten name and title of the signer.
ii) Ammendments :
• Identification of submission: Amendment, the DMF number, type of DMF, and the subject of the amendment.
• A description of the purpose of submission, e.g., update, revised formula, or revised process.
• Signature of the holder or the authorized representative.
• Typewritten name and title of the signer.
B. Administrative information about the submission:
DRUG MASTER FILE
Presented by :
RUSHIKESH D MENDHE
Roll no - 511
Mpharm Ist Year
(Department of Pharmaceutics)
Content : :
INTRODUCTION
TYPES OF DMF
DMF FORMAT & ASSEMBLY
DELIVERY OF DMF TO FDA
SUBMISSION OF DMF
THE MECHANISM OF A DRUG MASTER FILE
CTD & ELECTRONIC DMFS
UPDATES TO DMF
CLOSURE OF A DRUG MASTER FILE
APPLICATION OF DMF
REFERENCE
INTRODUCTION :
A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.
This guideline does not impose mandatory requirements.
Objectives :
Main Objective of the DMF is to support regulatory requirements
To prove the quality, safety and efficacy of the medicinal product
TYPES OF DMF :
DMF FORMAT & ASSEMBLY :
The DMF is submitted as Original and Duplicate jackets, collated, assembled, paginated, and jacketed, using covers obtained from the government printing office and a respecifically provided for the DMFs
Multiple volumes are numbered, and the paper must be standard paper size
Paper length should not be less than 10 inches nor more than 12 inches.
Each volume of a DMF should be not more than 2 inches thick
DELIVERY OF DMF TO FDA :
DMF should be submitted at following address :
Food and Drug Administration Center for Drug Evaluation and Research Central Document Room 5901 – B Ammendale Road Beltsville, MARYLAND 20705-1266 USA
SUBMISSION OF DMF :
The DMF must be submitted in two copies, one with a blue cover and one with a red cover.
Each page of each copy of the DMF should be dated and consecutively numbered.
Each DMF submission should contain :
• A Transmittal letter
• Administrative information about the submission
• Other specific information
A. Transmittal Letter :
i) Original Submissions :
• Identification of submission: Original, the type of DMF as classified in Section III, and its subject.
• Identification of the applications, if known, that the DMF is intended to support, including the name and address of each sponsor, applicant, or holder, and all relevant document numbers.
• Signature of the holder or the authorized representative.
• Typewritten name and title of the signer.
ii) Ammendments :
• Identification of submission: Amendment, the DMF number, type of DMF, and the subject of the amendment.
• A description of the purpose of submission, e.g., update, revised formula, or revised process.
• Signature of the holder or the authorized representative.
• Typewritten name and title of the signer.
B. Administrative information about the submission:
- Whilst the realization of the CTD took many years, there is now a common format for the submission of Marketing Authorizations Applications across the three ICH regions - Europe, Japan and the USA.
- This should facilitate pharmaceutical companies to make simultaneous filings in the ICH regions as it will eliminate the extensive work previously required to convert, for example, a US dossier to an EU dossier and vice versa.
I. INTRODUCTION
II. DEFINITIONS
III. TYPES OF DRUG MASTER FILES
IV. SUBMISSIONS TO DRUG MASTER FILES
V. AUTHORIZATION TO REFER TO A DRUG MASTER FILE
VI. PROCESSING AND REVIEWING POLICIES
VII. HOLDER OBLIGATIONS
IX. CLOSURE OF A DRUG MASTER FILE.
Abbreviated New Drug Application [ANDA]Sagar Savale
An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA's CDER, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product.
- Whilst the realization of the CTD took many years, there is now a common format for the submission of Marketing Authorizations Applications across the three ICH regions - Europe, Japan and the USA.
- This should facilitate pharmaceutical companies to make simultaneous filings in the ICH regions as it will eliminate the extensive work previously required to convert, for example, a US dossier to an EU dossier and vice versa.
I. INTRODUCTION
II. DEFINITIONS
III. TYPES OF DRUG MASTER FILES
IV. SUBMISSIONS TO DRUG MASTER FILES
V. AUTHORIZATION TO REFER TO A DRUG MASTER FILE
VI. PROCESSING AND REVIEWING POLICIES
VII. HOLDER OBLIGATIONS
IX. CLOSURE OF A DRUG MASTER FILE.
Abbreviated New Drug Application [ANDA]Sagar Savale
An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA's CDER, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product.
A Brief presentation on the Code of Federal Regulations in Pharmaceuticals (21 CFR), which covers the following aspects:
- Introduction to CFR
- Organization and structure of CFR
- History of CFR
- Table of Contents
- Title 21; CFR in Pharmaceuticals
- IND Application process regulations
- Research tools in CFR
The First Book in a three-part series explaining the regulations triggered when your organization acquires and uses chemicals. Learn about dozens of environmental, health and safety (EH&S) provisions intended to ensure that those chemicals are managed safely.
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Visit WhiteHouse.gov/RegulatoryReform to view all the plans and learn more.
LIVING WITH THE EARTHObjectives for this C.docxcroysierkathey
LIVING WITH THE EARTH
Objectives for this Chapter
A student reading this chapter will be able to:
1. Discuss how a law is made and describe the system of environmental laws.
2. List and describe the major components of the major federal environmental laws including: RCRA, CERCLA, EPCRA,SARA Title III, Pollution Prevention Act, CAA, CWA, SDWA, stormwater regulations, pesticide regulations, and underground storage tank regulations.
Objectives for this Chapter
A student reading this chapter will be able to:
3. Describe and discuss the major components of environmental compliance.
The Making of a LawBill is first introduced into house and senate;Referred to subcommittee for review and support;90% fail at this levelRecommended bills are brought forward for hearings and comment;Committee meets to mark up (discuss) bill and vote on it;If still found favorable, bill is sent to full chamber;
The Making of a Law (cont.)The bill is then sent to the Rules committee of House where a time limit is set for debate and other rules are set.The bill is also sent to the Senate where unrelated riders may be attached to a popular bill.House and Senate usually make changes in the bill before passing, and the different versions are sent to a conference committee for resolution.
SENATE
HOUSE
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Senate version
House version
CONFERENCE COMMITTEE
BILL
BILL
BILL
The Making of a Law (cont.)If a resolution is accepted and the same version is approved by both House and Senate, the bill moves forward to the President who may sign or veto it.Congress can override a veto by 2/3rds majority, but this is difficult to do.
CONFERENCE COMMITTEE
SENATE
HOUSE
If both Chambers approve final version, the bill is sent forward to the president
Veto?
Sign?
PRESIDENT
BILL
Common Themes Among Environmental LawsEIGHT GENERIC COMPLIANCE OBLIGATIONS1. Notification requirements2. Discharge or waste controls3. Process controls and pollution prevention4. Product controls5. Regulation of activities6. Safe transportation requirements7. Response and remediation requirements8. Compensation requirements
Environmental Laws are Part of a SystemENVIRONMENTAL LAW ENCOMPASSES ALL THE ENVIRONMENTAL PROTECTION THAT COMES FROM:U.S. CONSTITUTION AND STATE CONSTITUTIONSFEDERAL AND STATE STATUTES AND LOCAL ORDINANCESREGULATIONS PUBLISHED BY FEDERAL, STATE AND LOCAL AGENCIESPRESIDENTIAL EXECUTIVE ORDERSCOURT DECISIONS INTERPRETING THESE LAWSTHE COMMON LAW
Executive OrdersThese are orders issued by the president and require federal facilities to comply and provide leadership in protecting the environment. More than 18 executive orders have been issued since 1970.
Common LawA body of rules and principles that pertain to the government and the security of persons and property.Basic rules originally developed in England and then brought to American Colonies.
Under Common LawTortA private wrong or wrongful act for which the injured party c ...
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Code of Federal Regulations
1. www.ngsmips.nitte.edu.in
CODE OF FEDERAL REGULATIONS
(CFR)
DEPT OF PHARMACEUTICAL REGULATORY AFFAIRS
REGULATORY ASPECTS OF DRUGS AND COSMETICS
N.G.S.M. INSTITUTE OF PHARMACEUTICAL SCIENCES,
NITTE (DEEMED TO BE UNIVERSITY)
MANGALORE
- SWAPNIL D. FERNANDES
3. www.ngsmips.nitte.edu.in
What is CFR ?
The CFR is divided into 50 titles that represent broad areas
subject to federal regulation.
The Code of Federal
Regulations (CFR) is the
codification of the general and
permanent rules and
regulations (sometimes called
administrative law) published
in the Federal Register by the
executive departments and
agencies of the federal
government of the United
States.
4. www.ngsmips.nitte.edu.in
Each title is further divided into chapters, subchapters,
parts, and sections.
A regulation is cited by title, part, and section, e.g. 14 CFR
121.313 (Title 14, Part 121, Section 313).
The soft-cover volumes of the CFR are issued each year :
Titles 1 – 16 are updated as of January 1
Titles 17 – 27 are updated as of April 1
Titles 29 – 41 are updated as of July 1
Titles 42 – 50 are updated as of October 1
The online CFR is a joint project authorized by the publisher,
the National Archives and Records Administration's (NARA)
Office of the Federal Register (OFR), and the Government
Publishing Office (GPO) to provide the public with enhanced
access to Government information.
7. www.ngsmips.nitte.edu.in
HISTORY OF CFR
Franklin D. Roosevelt – 32nd President of the US.
1935 - Instrumental in passing the Federal
Register Act – empowered the National Archives
of the US to form an Administrative Committee –
publish the Federal Register.
The Federal Register Act - amended in 1937 to
provide a “codification” of all regulations every
five years – known as Code of Federal
Regulations.
8. www.ngsmips.nitte.edu.in
HISTORY OF CFR
The first edition of the CFR was published in 1938 and
included all finalized regulations that were published in
the Federal Register from March 14, 1936 to June 1, 1938
Beginning in 1963 for some titles and for all titles in 1967,
the Office of the Federal Register began publishing yearly
revisions.
Beginning in 1972 - published revisions were conducted in
staggered quarters.
10. www.ngsmips.nitte.edu.in
CFR TITLE 21
Title 21 of the CFR is reserved for rules of the Food
and Drug Administration.
Governs food and drugs within the United States for
the FDA, DEA, and the ONDCP.
In all, 21 CFR consists of 1499 parts.
It is divided into three chapters:
Chapter I — Food and Drug Administration
Chapter II — Drug Enforcement Administration
Chapter III — Office of National Drug Control
Policy
11. www.ngsmips.nitte.edu.in
CHAPTER I
Most of the Chapter I regulations are based on the
Federal Food, Drug, and Cosmetic Act.
Notable sections:
– 11 Electronic records and electronic signature related.
– 50 Protection of human subjects in clinical trials.
– 54 Financial Disclosure by Clinical Investigators.
– 56 Institutional Review Boards that oversee clinical
trials.
– 58 Good Laboratory Practices (GLP) for nonclinical
studies.
12. www.ngsmips.nitte.edu.in
The 100 series are regulations pertaining to food.
The 200 and 300 series are regulations pertaining
to pharmaceuticals
The 500 series are regulations for animal feeds
and animal medications.
The 600 series covers biological products.
The 700 series includes the limited regulations
on cosmetics.
The 800 series are for medical devices.
13. www.ngsmips.nitte.edu.in
The 900 series covers mammography quality requirements
enforced by CDRH.
The 1000 series covers radiation-emitting device
The 1100 series includes updated rules with regards to
tobacco products.
The 1200 series consists of rules primarily based in laws
other than the Food, Drug, and Cosmetic Act:
– Requirements for pasteurization of milk.
– Sanitation on interstate conveyances.
14. www.ngsmips.nitte.edu.in
CHAPTER II
Notable sections:
– 1308 — Schedules of controlled substances
1308.03(a) — Administrative Controlled Substances
Code Number
1308.11 — List of Schedule I drugs
1308.12 — List of Schedule II drugs
1308.13 — List of Schedule III drugs
1308.14 — List of Schedule IV drugs
1308.15 — List of Schedule V drugs
15. www.ngsmips.nitte.edu.in
The list of SCHEDULED DRUGS, as a part of the Controlled
Substances Act, falls under the drug policy of the United
States government. The following findings are required for
drugs to be placed in the aforementioned schedules:
– The drug or other substance has a high potential for abuse.
– The drug or other substance has no currently accepted medical
use in treatment in the United States.
– There is a lack of accepted safety for use of the drug or other
substance under medical supervision.
Administrative Controlled Substances Code Number
(ACSCN)
16. www.ngsmips.nitte.edu.in
CFR in Modern Times
• There are a number of electronic sources for accessing CFR.
• For instance - FDsys.gov and the now GovInfo, the official
online document repository for the U.S. Government
Publishing Office, is fully browsable, searchable, navigable
by citation.
• GPO also maintains an up-to-date “Electronic Code of
Federal Regulations (e-CFR)” service which presents CFR
sections in their current form with any recent amendments
from the Federal Register already incorporated. The e-CFR
service is updated daily and also allows you to separately
view appendices and supplements
17. www.ngsmips.nitte.edu.in
Research Tools in CFR
TABLE OF CONTENTS –
– CFR titles are broken down by chapter, subchapter, and
part .
– Immediately preceding each part is a table of contents for
the individual regulations contained within that part .
TABLE OF CFR TITLES AND CHAPTERS –
– Redesignation tables to help trace new location of parts
and sections of A regulation
LIST OF CFR SECTIONS AFFECTED IN THE VOLUME –
– List of CFR Sect ions Affected in Each Volume indicates the
Type of Change that was made.
18. www.ngsmips.nitte.edu.in
CONCLUSION
The Federal Register and the Code of Federal Regulations
replaced the existing system of dual set of regulations and
legislations that were in place.
Although not perfect, the Federal Register and the CFR
appear to have met their original purpose of providing the
public with a comprehensive publication vehicle for all the
regulations issued by Federal agencies and the President.
The CFR provided a codified form of the regulations, based
on title, chapters and subjects, that streamlined the
process of finding the required regulations and laws for the
pharmaceutical industry and the public in general, thereby
making these guidelines easily accessible.
19. www.ngsmips.nitte.edu.in
REFERENCES
http://www.llsdc.org/fr-cfr-research-guide
(Accessed on 12th February 2018)
Panama Refining Co. v. Ryan, 293 U.S. 388 (1935). Available from:
https://supreme.justia.com/cases/federal/us/293/388/case.html
Griswold, E.N. Government in ignorance of the law; a plea for better
publication of executive legislation. 48 Harv. L. Rev. 198-215 (1934).
Available from: https://public.resource.org/48HarvLRev198.pdf
CFR - Code of Federal Regulations Title 21. Available from :
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cf
m
(Accessed on 13th February 2018)
https://en.wikipedia.org/wiki/Title_21_of_the_Code_of_Federal_Regul
ations
(Accessed on 13th February 2018)
Editor's Notes
The regulations are first published (chronologically) in the Federal Register on a daily basis - then codified in the Code
of Federal Regulations.
When codified, they are arranged by title, then by chapter and then by subject.
Volumes are issued in sets on a staggered, quarterly basis
President from 1933 - 1945
A revised Title 21 is issued on approximately April 1st of each year.
the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP).
1st being general enforcement and general administrative rulings, all the way to schedules for controlled substances and registration of manufacturers, importers, distributors.
106-107 requirements for infant formula, 110 cGMPs for food products, 111 et seq. cGMPs for Dietary Supplements, 190 dietary supplements.
202-203 Drug advertising and marketing, 210 cGMPs for pharmaceuticals, 310 Requirements for new drugs, 328 Specific requirements for (OTC) drugs.
601 Licensing under section 351 of the Public Health Service Act, 606 cGMPs for human blood and blood products
803 Medical Device Reporting, 814 Premarket Approval of Medical Devices
Acscn is a number assigned to drugs listed on the schedules created by the Controlled Substances Act. For example, heroin is assigned 9200.