The Code of Federal Regulations (CFR) contains the general and permanent rules published by the executive departments and agencies of the federal government of the United States. Title 21 of the CFR governs food and drugs and is divided into three chapters addressing the Food and Drug Administration, Drug Enforcement Administration, and Office of National Drug Control Policy. Chapter I includes regulations for clinical trials, Good Laboratory Practices, food labeling, and current good manufacturing practices for pharmaceuticals. Title 21 provides the framework for approval of new drugs and biologics in the United States.
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
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:
it provide a brief note on the drug excipient interaction and various technique to find it which is a part of preformulation studies. it gives help to mpharm(pharmaceutics) students. i.
The Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product (IB) obtained during a drug trial.
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
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:
it provide a brief note on the drug excipient interaction and various technique to find it which is a part of preformulation studies. it gives help to mpharm(pharmaceutics) students. i.
The Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product (IB) obtained during a drug trial.
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
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
Rules committee
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 ...
Pharmaceutical Jurisprudence SCHEDULES
By_ Nakul Dhore
❖Schedules to the Act (02)
❖Schedules to the Rules (23)
❖Appendices (06)
❖Important Acts & Years
❖Multiple Choice Questions
Pharmaceutical Jurisprudence
Semester 5
As Per PCI Syllabus (New)
LIVING WITH THE EARTHCHAPTER 13ENVIRONMENTAL LAWS & COMP.docxcroysierkathey
LIVING WITH THE EARTH
CHAPTER 13
ENVIRONMENTAL LAWS
& COMPLIANCE
Page
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 Law
Bill is first introduced into house and senate;
Referred to subcommittee for review and support;
90% fail at this level
Recommended 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.
BILL
SENATE
HOUSE
Rules committee
BILL
BILL
Senate version
House version
CONFERENCE COMMITTEE
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
BILL
SENATE
HOUSE
If both Chambers approve final version, the bill is sent forward to the president
Veto?
Sign?
PRESIDENT
Page
Common Themes Among Environmental Laws
EIGHT GENERIC COMPLIANCE OBLIGATIONS
1. Notification requirements
2. Discharge or waste controls
3. Process controls and pollution prevention
4. Product controls
5. Regulation of activities
6. Safe transportation requirements
7. Response and remediation requirements
8. Compensation requirements
Environmental Laws are Part of a System
ENVIRONMENTAL LAW ENCOMPASSES ALL THE ENVIRONMENTAL PROTECTION THAT COMES FROM:
U.S. CONSTITUTION AND STATE CONSTITUTIONS
FEDERAL AND STATE STATUTES AND LOCAL ORDINANCES
REGULATIONS PUBLISHED BY FEDERAL, STATE AND LOCAL AGENCIES
PRESIDENTIAL EXECUTIVE ORDERS
COURT DECISIONS INTERPRETING THESE LAWS
THE COMMON LAW
Executive Orders
These 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 Law
A body of rules and principles that pertain to the government and the security of persons and property.
Basic rules originally developed in England and t ...
Health in Indian Federal system consists of how the different health related responsibilities are being divided among centre, state and concurrent list for better administration and health care delivery in India.
This pdf is about the Schizophrenia.
For more details visit on YouTube; @SELF-EXPLANATORY;
https://www.youtube.com/channel/UCAiarMZDNhe1A3Rnpr_WkzA/videos
Thanks...!
Comparing Evolved Extractive Text Summary Scores of Bidirectional Encoder Rep...University of Maribor
Slides from:
11th International Conference on Electrical, Electronics and Computer Engineering (IcETRAN), Niš, 3-6 June 2024
Track: Artificial Intelligence
https://www.etran.rs/2024/en/home-english/
Cancer cell metabolism: special Reference to Lactate PathwayAADYARAJPANDEY1
Normal Cell Metabolism:
Cellular respiration describes the series of steps that cells use to break down sugar and other chemicals to get the energy we need to function.
Energy is stored in the bonds of glucose and when glucose is broken down, much of that energy is released.
Cell utilize energy in the form of ATP.
The first step of respiration is called glycolysis. In a series of steps, glycolysis breaks glucose into two smaller molecules - a chemical called pyruvate. A small amount of ATP is formed during this process.
Most healthy cells continue the breakdown in a second process, called the Kreb's cycle. The Kreb's cycle allows cells to “burn” the pyruvates made in glycolysis to get more ATP.
The last step in the breakdown of glucose is called oxidative phosphorylation (Ox-Phos).
It takes place in specialized cell structures called mitochondria. This process produces a large amount of ATP. Importantly, cells need oxygen to complete oxidative phosphorylation.
If a cell completes only glycolysis, only 2 molecules of ATP are made per glucose. However, if the cell completes the entire respiration process (glycolysis - Kreb's - oxidative phosphorylation), about 36 molecules of ATP are created, giving it much more energy to use.
IN CANCER CELL:
Unlike healthy cells that "burn" the entire molecule of sugar to capture a large amount of energy as ATP, cancer cells are wasteful.
Cancer cells only partially break down sugar molecules. They overuse the first step of respiration, glycolysis. They frequently do not complete the second step, oxidative phosphorylation.
This results in only 2 molecules of ATP per each glucose molecule instead of the 36 or so ATPs healthy cells gain. As a result, cancer cells need to use a lot more sugar molecules to get enough energy to survive.
Unlike healthy cells that "burn" the entire molecule of sugar to capture a large amount of energy as ATP, cancer cells are wasteful.
Cancer cells only partially break down sugar molecules. They overuse the first step of respiration, glycolysis. They frequently do not complete the second step, oxidative phosphorylation.
This results in only 2 molecules of ATP per each glucose molecule instead of the 36 or so ATPs healthy cells gain. As a result, cancer cells need to use a lot more sugar molecules to get enough energy to survive.
introduction to WARBERG PHENOMENA:
WARBURG EFFECT Usually, cancer cells are highly glycolytic (glucose addiction) and take up more glucose than do normal cells from outside.
Otto Heinrich Warburg (; 8 October 1883 – 1 August 1970) In 1931 was awarded the Nobel Prize in Physiology for his "discovery of the nature and mode of action of the respiratory enzyme.
WARNBURG EFFECT : cancer cells under aerobic (well-oxygenated) conditions to metabolize glucose to lactate (aerobic glycolysis) is known as the Warburg effect. Warburg made the observation that tumor slices consume glucose and secrete lactate at a higher rate than normal tissues.
(May 29th, 2024) Advancements in Intravital Microscopy- Insights for Preclini...Scintica Instrumentation
Intravital microscopy (IVM) is a powerful tool utilized to study cellular behavior over time and space in vivo. Much of our understanding of cell biology has been accomplished using various in vitro and ex vivo methods; however, these studies do not necessarily reflect the natural dynamics of biological processes. Unlike traditional cell culture or fixed tissue imaging, IVM allows for the ultra-fast high-resolution imaging of cellular processes over time and space and were studied in its natural environment. Real-time visualization of biological processes in the context of an intact organism helps maintain physiological relevance and provide insights into the progression of disease, response to treatments or developmental processes.
In this webinar we give an overview of advanced applications of the IVM system in preclinical research. IVIM technology is a provider of all-in-one intravital microscopy systems and solutions optimized for in vivo imaging of live animal models at sub-micron resolution. The system’s unique features and user-friendly software enables researchers to probe fast dynamic biological processes such as immune cell tracking, cell-cell interaction as well as vascularization and tumor metastasis with exceptional detail. This webinar will also give an overview of IVM being utilized in drug development, offering a view into the intricate interaction between drugs/nanoparticles and tissues in vivo and allows for the evaluation of therapeutic intervention in a variety of tissues and organs. This interdisciplinary collaboration continues to drive the advancements of novel therapeutic strategies.
Professional air quality monitoring systems provide immediate, on-site data for analysis, compliance, and decision-making.
Monitor common gases, weather parameters, particulates.
Deep Behavioral Phenotyping in Systems Neuroscience for Functional Atlasing a...Ana Luísa Pinho
Functional Magnetic Resonance Imaging (fMRI) provides means to characterize brain activations in response to behavior. However, cognitive neuroscience has been limited to group-level effects referring to the performance of specific tasks. To obtain the functional profile of elementary cognitive mechanisms, the combination of brain responses to many tasks is required. Yet, to date, both structural atlases and parcellation-based activations do not fully account for cognitive function and still present several limitations. Further, they do not adapt overall to individual characteristics. In this talk, I will give an account of deep-behavioral phenotyping strategies, namely data-driven methods in large task-fMRI datasets, to optimize functional brain-data collection and improve inference of effects-of-interest related to mental processes. Key to this approach is the employment of fast multi-functional paradigms rich on features that can be well parametrized and, consequently, facilitate the creation of psycho-physiological constructs to be modelled with imaging data. Particular emphasis will be given to music stimuli when studying high-order cognitive mechanisms, due to their ecological nature and quality to enable complex behavior compounded by discrete entities. I will also discuss how deep-behavioral phenotyping and individualized models applied to neuroimaging data can better account for the subject-specific organization of domain-general cognitive systems in the human brain. Finally, the accumulation of functional brain signatures brings the possibility to clarify relationships among tasks and create a univocal link between brain systems and mental functions through: (1) the development of ontologies proposing an organization of cognitive processes; and (2) brain-network taxonomies describing functional specialization. To this end, tools to improve commensurability in cognitive science are necessary, such as public repositories, ontology-based platforms and automated meta-analysis tools. I will thus discuss some brain-atlasing resources currently under development, and their applicability in cognitive as well as clinical neuroscience.
Nutraceutical market, scope and growth: Herbal drug technologyLokesh Patil
As consumer awareness of health and wellness rises, the nutraceutical market—which includes goods like functional meals, drinks, and dietary supplements that provide health advantages beyond basic nutrition—is growing significantly. As healthcare expenses rise, the population ages, and people want natural and preventative health solutions more and more, this industry is increasing quickly. Further driving market expansion are product formulation innovations and the use of cutting-edge technology for customized nutrition. With its worldwide reach, the nutraceutical industry is expected to keep growing and provide significant chances for research and investment in a number of categories, including vitamins, minerals, probiotics, and herbal supplements.
Code of federal regulations {cfr} in pharmaceutical
1. CODE OF FEDERAL REGULATIONS
{CFR}IN PHARMACEUTICAL
Presented by
Arabinda Changmai
M.Pharm 1st sem
Assam downtown university
Guided by
Dr. Satyendra Deka
Associate professor
Department of pharmacy
Assam downtown university
3. The Code of Federal Regulations (CFR) is the codification of the general and
permanent rules and regulations published in the Federal Register by the
executive departments and agencies of the federal government of the United
States.
The CFR annual edition is the codification of the general and permanent rules
published by the Office of the Federal and the Government Publishing Office. In
addition to this annual edition, the CFR is published in an unofficial format
online on the Electronic CFR website, which is updated daily.
3 INTRODUCTION
4. The regulations that are published orderly in the Federal Register are
codified and arranged by title, then by chapter (one agency’s regulations) and
finally by subject in the CFR.
The CFR is divided into 50 titles which represent broad areas subject to
federal regulation. Each title is 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).
4
5. The soft-cover volumes of the CFR are issued each year in sets on a staggered, quarterly
basis:
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 color of each set of volumes is changed every year; a current full set may contain
different colored volumes, depending on the time of the year.
The Office of the Federal Register also keeps an unofficial, online version of the CFR,
the e-CFR, which is normally updated within two days after changes that have been
published in the Federal Register become effective.
5
6. CFR - Table of Contents
e - CFR
Title 1 - General Provisions
Title 2 - Grants and Agreements
Title 3 - The President
Title 4 - Accounts
Title 5 - Administrative Personnel
Title 6 - Domestic Security
Title 7 - Agriculture
6
7. Title 8 - Aliens and Nationality
Title 9 - Animals and Animal Products
Title 10 - Energy
Title 11 - Federal Elections
Title 12 - Banks and Banking
Title 13 - Business Credit and Assistance
Title 14 - Aeronautics and Space
Title 15 - Commerce and Foreign Trade
Title 16 - Commercial Practices
Title 17 - Commodity and Securities Exchanges
Title 18 - Conservation of Power and Water Resources
7
8. Title 19 - Customs Duties
Title 20 - Employees' Benefits
Title 21 - Food and Drugs
Title 22 - Foreign Relations
Title 23 - Highways
Title 24 - Housing and Urban Development
Title 25 - Indians
Title 26 - Internal Revenue
Title 27 - Alcohol, Tobacco Products and Firearms
Title 28 - Judicial Administration
Title 29 - Labor
Title 30 - Mineral Resources
8
9. Title 31 - Money and Finance: Treasury
Title 32 - National Defense
Title 33 - Navigation and Navigable Waters
Title 34 - Education
Title 35 - Panama Canal [Reserved]
Title 36 - Parks, Forests, and Public Property
Title 37 - Patents, Trademarks, and Copyrights
Title 38 - Pensions, Bonuses, and Veterans' Relief
Title 39 - Postal Service
Title 40 - Protection of Environment
Title 41 - Public Contracts and Property Management
9
10. Title 42 - Public Health
Title 43 - Public Lands: Interior
Title 44 - Emergency Management and Assistance
Title 45 - Public Welfare
Title 46 - Shipping
Title 47 - Telecommunication
Title 48 - Federal Acquisition Regulations System
Title 49 - Transportation
Title 50 - Wildlife and Fisheries
10
11. CFR in pharmaceuticals
Title 21 is the portion of the Code of Federal Regulations that governs food and
drugs within the United States for the Food and Drug Administration (FDA),
the Drug Enforcement Administration (DEA), and the Office of National Drug
Control Policy (ONDCP). 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
12. Chapter 1
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
The 100 series are regulations pertaining to food:
101, especially 101.9 — Nutrition facts label related
(c)(2)(ii) — Requirement to include trans fat values
(c)(8)(iv) — Vitamin and mineral values
106-107 requirements for infant formula
12
13. 110 et seq. cGMPs for food products
111 et seq. cGMPs for Dietary Supplements
170 food additives
190 dietary supplements
The 200 and 300 series are regulations pertaining to pharmaceuticals :
202-203 Drug advertising and marketing
210 et seq. cGMPs for pharmaceuticals
310 et seq. Requirements for new drugs
328 et seq. Specific requirements for over-the-counter (OTC) drugs.
The 500 series are regulations for animal feeds and animal medications:
510 et seq. New animal drugs
13
14. 556 Tolerances for residues of drugs in food animals
The 600 series covers biological products (e.g. vaccines, blood):
601 Licensing under section 351 of the Public Health Service Act
606 et seq. cGMPs for human blood and blood products
The 700 series includes the limited regulations on cosmetics:
701 Labeling requirements
The 800 series are for medical devices:
•803 Medical Device Reporting
•814 Premarket Approval of Medical Devices
•820 et seq. Quality system regulations (analogous to cGMP, but structured
like ISO)
•860 et seq. Listing of specific approved devices and how they are classified
14
15. The 900 series covers mammography quality requirements enforced
by CDRH.
The 1000 series covers radiation-emitting device (e.g. cell
phones, lasers, x-ray generators); requirements enforced by the Center for
Devices and Radiological Health. It also talks about the FDA citizen petition.
The 1100 series includes updated rules deeming items that statutorily come
under the definition of "tobacco product" to be subject to the Federal Food,
Drug, and Cosmetic Act as amended by the Tobacco Control Act. The items
affected include E-cigarettes, Hookah tobacco, and pipe tobacco.
15
16. The 1200 series consists of rules primarily based in laws other than the
Food, Drug, and Cosmetic Act:
•1240 Rules promulgated under 361 of the Public Health Service Act on
interstate control of communicable disease, such as:
• Requirements for pasteurization of milk
• Interstate shipment of turtles as pets.
• Interstate shipment of African rodents that may carry monkeypox.
• Sanitation on interstate conveyances (i.e. airplanes and ships)
•1271 Requirements for human cells, tissues, and cellular and tissue-based
products (i.e. the cGTPs).
16
17. 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
Chapter III
Notable sections:
1405 Governmentwide requirements for drug-free workplaces
17
18. The following regulations apply to the IND application process:
21CFR Part 50 Protection of Human Subjects
21CFR Part 54 Financial Disclosure by Clinical Investigators
21CFR Part 56 Institutional Review Boards
21CFR Part 58 Good Lab Practice for Nonclinical Laboratory [Animal] Studies
21CFR Part 201 Drug Labeling
21CFR Part 312 Investigational New Drug Application
21CFR Part 314 INDA and NDA Applications for FDA Approval to Market a New Drug
(New Drug Approval)
21CFR Part 316 Orphan Drugs
18