Drug Regulation & Control Flashcards
“prohibits the distribution and use of any new drug of drug product without prior filing of a new drug application(NDA) and approval of the FDA”
Sulfanilamide
Diethylene glycol poisoning
Federal Food and Drug Cosmetic Act of 1938
- “Prescription for legend drugs may not be refilled without the express consent of the prescriber”
- Drugs categorized according to manner in which they maybe legally obtained
- OTC use by lay-man in self-treatment of simple conditions in which competent medical care is not sought
- Prescription drugs – drugs that are considered useful only after expert diagnosis or too dangerous for use in self medication ( Rx or legend)
Durham-Humprey Amendment of 1952
Kefauver Harris Amendments
- Consolidate and codify control authority over drugs of abuse into a singke statute
- DEA Drug Enforcement Administration
Comprehensive Drug Abuse Prevention and Control Act of 1970
How many schedules for Classification and Control for Drug Substance
5 Schedules
acceptable medical use and low potential for abuse relative to those in schedule III (diphenoxin, diazepam, oxazepam)
Schedule IV
no accepted medical use and with high potential for abuse ( heroin, LSD,marijuana)
Schedule I
with acceptable medical use low potential for abuse ( Codeine, hydrocodone)
Schedule III
with acceptable medical uses and law potential for abuse relative to those in schedule IV (dihydrocodeine and diphenoxylate)
Schedule V
Drugs with acceptable medical uses and high potential for abuse that may lead to severe psychologic or physical dependence ( morphine, Cocaine methamphetamine, amobarbital)
Schedule II
Provide FDA legislative authority to compile a list of marketed drugs to assist in the enforcement of federal laws requiring that drugs be safe and effective and not adulterated or misbranded
Drug Listing Act of 1972
Applications for generic copies of an originally approved new drug can be filed through an abbreviated new drug application (ANDA)
Drug Price Competition and Patent Term Restoration Act of 1984
The act is intended to reduce the risk of adulterated, misbranded, repackaged and mislabeled drugs entering the legitimate marketplace through “secondary sources”
Prescription Drug Marketing Act of 1987
Summary of Prescription Drug Marketing Act of 1987
- Reimportation
- Sales Restrictions
- Distribution of Samples
- Wholesake distributors
Forbids manufacture or distribution of these products to make any advertising or labelling claims that indicates that the use of the product can prevent or cure any disease
The product is not intended to diagnose, treat , cure or prevent any disease
Dietary Supplement Health and Education Act of 1994
Enforce Federal Food, Drug and Cosmetic Act with additional responsibility in enforcing many additional pieces of legislation
The FDA and the Food and Drug Administration Modernization Act
Consists of 8 volumes containing all regulations issued under the Federal Food, Drug and Cosmetic Act and other statutes administered by the FDA
9th volume regulation issued under statutes issued by the DEA
Code of Federal Regulations and Federal Register
- How many volumes of the Code of Federal Regulations and Federal Register are there?
- What is the volume regulation issued under statues issued by DEA
- 8
- 9th volume
What does “DEA” mean?
Drug Enforcement Administration
If the FDA or manufacturer finds that a marketed product presents a threat or potential threat to consumer safety, the product may be recalled.
Drug Product Recall
a drug that contains no active moiety that has been approved by FDA in any other application submitted under section 505(b) of the act
New Chemical Entity
Sources of New Chemical Entity
- Plant Materials
- Animal Sources
- Reservoir for potential new drugs
- Botanical folklores remedies into modern wonder drug
Plant Materials
Examples of plant materials for drugs
- Reserpine from Rauwilfia serpentina
- Vinca rosea - Folklore
- Vinblastine & vincristine
What is Vinca rosea used for?
Diabetes
What is Vinblastine and vincristine’s therapeutic effect?
Antitumor
- creation of slightly different chemical structures
- Produce semi-synthetic drugs (inactive to active)
Molecular manipulation
Kinds of steroids (inactive) from which cortisone and estrogen are semi-synthetically produced
Dioscorea species
Where cortisone and estrogen are semi-synthetically produced
Steroids (inactive form)
(NCE) Examples of Animal Sources
- Tissues and biological processes
- Hormonal substances = thyroid extract, insulin
- Biologicals
(NCE) Examples of Biologicals in animal sources
- Poliomyelitis vaccine – renal monkey tissue
- Mumps and influenza vaccine – chick embryo
- Rubella – germanmeasles – duck embryo
- small pox vaccine – skin of bovine calf
Qualities and features are not completely attainable but they are still sought in drug and dosage form desire.
Goal Drug
2 types of Methods of Drug Duscovery screening
- Random or untargeted
- Non-random or Targeted
test large number of synthetic organic compounds or substances of natural origin for biological activity
Random or untargeted
use to determine a specific activity
Non-random or Targeted
Use to differentiate the effect and potency of the test agent from those controls of known action or effect
Bioassay
How can bioassay be done?
- In vitro
- In vivo
using more expensive and disease specific animal models
In-vivo
using cell cultures to test agents
In-vitro
chemical alteration of the known and previously characterized organic compound for the purpose of enhancing usefulness as a drug
Molecular Modifaction
Purposes of Molecular Modification
- Enhancing specificity for a particular body target site
- Increase potency
- Improving rate and extent of absorption
- Modifying the advantage of its time course in the body
- Reduce its toxicity
- Changing its physical and chemical properties
Molecular modification to design a drug that interferes specially with the known or suspected biochemical pathway or mechanism of a disease process
Mechanism-based drug design
Examples of drugs in molecular modificarion
- Enalaprilat (vasotec)– inhibits angiotensin converting enzyme—-prevents vasoconstriction——decreases vasopressor ———–decreases BP
- Ranitidine ( Zantac)——inhibits histamin at the H2 receptor——-inhibits gastric acid secretion
