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21 CFR
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 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 The 100 series are regulations pertaining to food: * 101, especially 101.9 — Nutrition facts label related ** (c)(2)(ii) — Requirement ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Code Of Federal Regulations
In the law of the United States, the ''Code of Federal Regulations'' (''CFR'') is the codification of the general and permanent regulatory law, regulations promulgated by the executive departments and agencies of the federal government of the United States. The CFR is divided into 50 titles that represent broad areas subject to federal regulation. The CFR annual edition is published as a special issue of the ''Federal Register'' by the Office of the Federal Register (part of the National Archives and Records Administration) and the Government Publishing Office. In addition to this annual edition, the CFR is published online on the Electronic CFR (eCFR) website, which is updated daily. Background Congress frequently delegates authority to an executive branch agency to issue regulations to govern some sphere. These statutes are called "authorizing statute" or "enabling statute" (or "authorizing legislation"). Authorizing statutes typically have two parts: (1) a substantive sc ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
CDRH
The Center for Devices and Radiological Health (CDRH) is one of six product centers of the U.S. Food and Drug Administration (FDA), an agency that is part of the U.S. Department of Health and Human Services (HHS). CDRH is responsible for ensuring that patients and providers in the U.S. have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. Examples of products that CDRH regulates include medical devices ranging from tongue depressors and personal protective equipment (PPE) to pacemakers and robotic surgical systems, and medical and non-medical radiation-emitting electronic products such as lasers, x-ray systems, ultrasound equipment, microwave ovens, and color televisions. As of October 2024, the Director of CDRH is Michelle Tarver M.D., Ph.D. Organization structure CDRH consists of seven offices that work in collaboration to assure that consumers have access to safe and effective medical products. * Of ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
List Of Schedule I Drugs
This is the list of Schedule I controlled substances in the United States as defined by the Controlled Substances Act.21 CFRbr>1308.11 (CSA Sched I) with changes through (Oct 18, 2012). Retrieved September 6, 2013. The following findings are required for substances to be placed in this schedule: United States Code via Cornell University's Legal Information Institute The Legal Information Institute (LII) is a non-profit public service of Cornell Law School that provides no-cost access to current American and international legal research sources online. Founded in 1992 by Peter Martin and Tom Bruce, LII .... Retrieved on 2007-10-02. # 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. The complete list of Schedule I substances is as follows. The Administrative C ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Administrative Controlled Substances Code Number
Administrative Controlled Substances Code Number (ACSCN) is a number assigned to drugs listed on the schedules created by the US Controlled Substances Act (CSA). The ACSCN is defined in 21 CFR § 1308.03(a). Each chemical/drug on one of the schedules is assigned an ACSCN (for example, heroin is assigned 9200). The code number is used on various documents used in administration of the system mandated by the CSA. ACSCN tables include the CSA schedule, common alternative chemical and trade names, and the free base conversion ratio (the molecular mass of the substance in question divided by the molecular mass of the free base). This is used to make meaningful qualitative comparisons between substances, and labeling of the end product may, as is required in many European countries, list the active substance using both (e.g. "each tablet contains 120 mg dihydrocodeine bitartrate, representing 80 mg dihydrocodeine base"). This method of citation is in theory compulsory worldwide for subst ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Current Good Tissue Practices
Good tissue practice (GTP) is one of the " GxP" requirements derived from good manufacturing practice. The rule was written and is enforced by the U.S. Food and Drug Administration (FDA), specifically the Center for Biologics Evaluation and Research. The authority for the regulation comes from the Public Health Service Act and all of the requirements relate to transmission of communicable disease, including bacterial or fungal contamination during processing. It is generally used to mean the requirements of section 1271 of chapter 21 of the US Code of Federal Regulations, though the rule itself specifies that the GTP is only subpart D of that section. The rules cover a broad variety of articles referred to as "HCT/Ps" for human cellular, tissue, and tissue-based products and the regulations cover more or less any cellular entity taken from a human and transplanted into another human. There are several exceptions in the rules for organ transplants, blood for transfusion, and other ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Monkeypox
Mpox (, ; formerly known as monkeypox) is an infectious viral disease that can occur in humans and other animals. Symptoms include a rash that forms blisters and then crusts over, fever, and lymphadenopathy, swollen lymph nodes. The illness is usually mild, and most infected individuals recover within a few weeks without treatment. The time from incubation period, exposure to the onset of symptoms ranges from three to seventeen days, and symptoms typically last from two to four weeks. However, cases may be severe, especially in children, pregnant women, or people with Immunodeficiency, suppressed immune systems. The disease is caused by the monkeypox virus, a zoonotic virus in the genus ''Orthopoxvirus''. The variola virus, which causes smallpox, is also in this genus. Human-to-human transmission can occur through direct contact with infected skin or body fluids, including sexual contact. People remain infectious from the onset of symptoms until all the lesions have scabbed ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Rodents
Rodents (from Latin , 'to gnaw') are mammals of the order Rodentia ( ), which are characterized by a single pair of continuously growing incisors in each of the upper and lower jaws. About 40% of all mammal species are rodents. They are native to all major land masses except for Antarctica, and several oceanic islands, though they have subsequently been introduced to most of these land masses by human activity. Rodents are extremely diverse in their ecology and lifestyles and can be found in almost every terrestrial habitat, including human-made environments. Species can be arboreal, fossorial (burrowing), saltatorial/ricochetal (leaping on their hind legs), or semiaquatic. However, all rodents share several morphological features, including having only a single upper and lower pair of ever-growing incisors. Well-known rodents include mice, rats, squirrels, prairie dogs, porcupines, beavers, guinea pigs, and hamsters. Once included with rodents, rabbits, hares, and p ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Turtle
Turtles are reptiles of the order (biology), order Testudines, characterized by a special turtle shell, shell developed mainly from their ribs. Modern turtles are divided into two major groups, the Pleurodira (side necked turtles) and Cryptodira (hidden necked turtles), which differ in the way the head retracts. There are 360 living and recently extinct species of turtles, including land-dwelling tortoises and freshwater terrapins. They are found on most continents, some islands and, in the case of sea turtles, much of the ocean. Like other Amniote, amniotes (reptiles, birds, and mammals) they breathe air and do not lay eggs underwater, although many species live in or around water. Turtle shells are made mostly of bone; the upper part is the domed Turtle shell#Carapace, carapace, while the underside is the flatter plastron or belly-plate. Its outer surface is covered in scale (anatomy), scales made of keratin, the material of hair, horns, and claws. The carapace bones deve ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Milk
Milk is a white liquid food produced by the mammary glands of lactating mammals. It is the primary source of nutrition for young mammals (including breastfeeding, breastfed human infants) before they are able to digestion, digest solid food. Milk contains many nutrients, including calcium and protein, as well as lactose and saturated fat; the enzyme lactase is needed to break down lactose. Immune factors and immune-modulating components in milk contribute to milk immunity. The first milk, which is called colostrum, contains antibody, antibodies and immune-modulating components that milk immunity, strengthen the immune system against many diseases. As an agricultural product, Milking, milk is collected from farm animals, mostly cattle, on a dairy. It is used by humans as a drink and as the base ingredient for dairy products. The US Centers for Disease Control and Prevention, CDC recommends that children over the age of 12 months (the minimum age to stop giving breast milk or Ba ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Pasteurization
In food processing, pasteurization (American and British English spelling differences#-ise, -ize (-isation, -ization), also pasteurisation) is a process of food preservation in which packaged foods (e.g., milk and fruit juices) are treated with mild heat, usually to less than , to eliminate pathogens and extend shelf life. Pasteurization either destroys or deactivates microorganisms and enzymes that contribute to food spoilage or the risk of disease, including vegetative bacteria, but most Endospore, bacterial spores survive the process. Pasteurization is named after the French microbiologist Louis Pasteur, whose research in the 1860s demonstrated that thermal processing would deactivate unwanted microorganisms in wine. Spoilage enzymes are also inactivated during pasteurization. Today, pasteurization is used widely in the dairy industry and other food processing industries for food preservation and food safety. By the year 1999, most liquid products were heat treated in a co ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
FDA Citizen Petition
An FDA citizen petition is a process provided by the United States Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ... (FDA) for individuals and community organizations to make requests to the FDA for changes to health policy. It is described in Title 21 of the Code of Federal Regulations (21 CFR Part 10). Pharmaceutical companies routinely use FDA citizen petitions to delay the entry of generic drugs into the United States marketplace. Companies use this to counter the parts of the Drug Price Competition and Patent Term Restoration Act, which make generic drugs more available. In 2016, Pharmaceutical Research and Manufacturers of America requested various changes to the FDA petition process, which the FDA declined. In November 2016, the FDA updated t ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Center For Devices And Radiological Health
The Center for Devices and Radiological Health (CDRH) is one of six product centers of the U.S. Food and Drug Administration (FDA), an agency that is part of the U.S. Department of Health and Human Services (HHS). CDRH is responsible for ensuring that patients and providers in the U.S. have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. Examples of products that CDRH regulates include medical devices ranging from tongue depressors and personal protective equipment (PPE) to pacemakers and robotic surgical systems, and medical and non-medical radiation-emitting electronic products such as lasers, x-ray systems, ultrasound equipment, microwave ovens, and color televisions. As of October 2024, the Director of CDRH is Michelle Tarver M.D., Ph.D. Organization structure CDRH consists of seven offices that work in collaboration to assure that consumers have access to safe and effective medical products. * Of ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
