- How is the FDA organized?
- Which consumer protection laws is the FDA tasked with enforcing?
- Can the FDA regulate drugs that are a part of intrastate commerce?
- What are substandard drugs?
- What is the meaning of adulterated food?
- What is the difference between falsified and counterfeit medicines?
- What are adulterated drugs devices?
- Who enforces FDA regulations?
- What are two consequences for noncompliance to the FDA regulations?
- What is Misbrandment?
- What is the term which states that a drug is prepared packed or held under unsanitary conditions?
- What are the effects of fake drugs?
- What is meant by drug quality?
- What is the definition of misbranded food?
- What are adulterated drugs?
- Why are adulterants used?
How is the FDA organized?
It consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations..
Which consumer protection laws is the FDA tasked with enforcing?
Under the Federal Food, Drug, and Cosmetic Act (the Act), FDA has the broad mandate to assure safety and effectiveness of drugs (including animal drugs), devices (including veterinary devices), and the safety of the food supply.
Can the FDA regulate drugs that are a part of intrastate commerce?
While primarily focused on interstate commerce, FDA’s authority extends to intrastate activities that have a nexus with interstate commerce and concern a product that the Act covers. … For serious FD&C Act violations, the FDA, in coordination with DOJ, has a wide range of civil and criminal remedies.
What are substandard drugs?
Substandard medicines are pharmaceutical products that do not meet their quality standards and specifications. … The WHO defines ‘counterfeit’ drugs as ‘medicines that are deliberately and fraudulently mislabelled with respect to identity and/or source’ .
What is the meaning of adulterated food?
Food adulteration is the act of intentionally debasing the quality of food offered for sale either by the admixture or substitution of inferior substances or by the removal of some valuable ingredient.
What is the difference between falsified and counterfeit medicines?
Falsified medicines refer to medicines which do not meet the standards of safety, efficacy and quality as are required under strict EU law. … Counterfeit medicines, on the other hand, refer to medicinal products that infringe upon the intellectual property rights (“IPRs”) owned by the proprietor of the said rights.
What are adulterated drugs devices?
A drug or device shall be deemed to be adulterated: (a) (1) If it consists in whole or in part of any filthy, putrid, decomposed substance; or (2) if it has been prepared, packed, or held under insanitary conditions contaminated with filth or whereby it may have been rendered injurious to health; or (3) if it is a drug …
Who enforces FDA regulations?
The FDA’s primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C), but the agency also enforces other laws, notably Section 361 of the Public Health Service Act, as well as associated regulations….Food and Drug Administration.Agency overviewParent agencyDepartment of Health and Human Services10 more rows
What are two consequences for noncompliance to the FDA regulations?
Failure to comply within the thirty (30) days of receipt of Notice of Noncompliance will result in FDA escalating regulatory action, including civil monetary penalties, of up to $10,000 for all violations adjudicated in a single proceeding.
What is Misbrandment?
Misbranding is defined as the practice of incorporating in the product name a geographical location which is different from that declared in the responsibility statement. For example, the if product name was “Hawaii Cookies” and the product was manufactured in California, the product would be misbranded.
What is the term which states that a drug is prepared packed or held under unsanitary conditions?
Adulteration. •Consisting “in whole or in part of any filthy, putrid, or decomposed substance” •”prepared, packed, or held under unsanitary conditions” •prepared in containers “composed, in whole or in part, of any poisonous or deleterious substance”
What are the effects of fake drugs?
Key Findings and Conclusions. Falsified and substandard drugs may contain toxic doses of dangerous ingredients and cause mass poisoning. Poor-quality medicines compromise the treatment of chronic and infectious diseases, causing disease progression, drug resistance, and death.
What is meant by drug quality?
Drug product quality defects are an important source of risk that affects drug product performance and can affect patient safety and therapeutic efficacy. Product quality includes strength and purity of the drug substance, the manufacturing process of the drug product and the monitoring of the manufacturing operations.
What is the definition of misbranded food?
A food is misbranded if one or more of the following conditions exists: … It is offered for sale under the name of another food with or without other descriptive words, or under any name which is likely to be misleading. 3. Its container is so made, formed or filled as to be misleading. 4.
What are adulterated drugs?
adjective Referring to a drug or device which: contains decomposed or putrid material; has been produced, prepared, packed or held under unsanitary conditions, and/or not in accordance with good manufacturing practice; contains an unsafe colour additive; has a strength and/or quality or purity which differs from that …
Why are adulterants used?
An adulterant is a chemical which acts as a contaminant when combined with other substances. Adulterants are added to pure substances to extend the quantity while reducing the quality.