A
The first law to regulate development, compounding, distribution, storage, and dispensing of drugs was passed by Congress in 1906 is known as
Pure Food and Drug Act
•Lower potential for abuse than Schedule I and Schedule II drugs
•Have accepted medical uses in the United States
•Contain limited quantities of certain narcotic and non-narcotic drugs
Schedule III
•When controlled substances from Schedule II are returned, __________ must be used
•May only be returned from one DEA registrant to another
•Any facility that does not have a DEA number cannot return controlled substances
DEA Form 222
•Have the lowest abuse potential of the controlled substances
•Consist of preparations with limited quantities of certain narcotic drugs
•Generally used for antitussive and antidiarrheal purposes, Usually require a prescription
Schedule V
•Also called the Controlled Substances Act (CSA), it directed manufacture, distribution, and dispensing of controlled substances that have the potential for addiction and abuse
•Replaced most previous narcotic and drug abuse control laws
•Classified drugs into 5 Schedules (I, II, III, IV, V)
The Comprehensive Drug Abuse Prevention and Control Act of 1970
•In 1912, Congress expanded the definition of _________ as “false or fraudulent claims for the curative powers of drugs”
misbranding
The form is not required when ordering Schedule III, IV, or V substances, which are ordered directly from manufacturers or drug wholesalers
DEA Form 222
•Each ________ contains:
–Storage requirements
–Handling procedures
–Steps to take if the chemical contacts the eyes or skin
Material Safety Data Sheets (MSDSs)
•Requires pharmacists to offer to discuss information about prescriptions with Medicare and Medicaid patients
•Pharmacists usually now counsel all patients
The Omnibus Budget Reconciliation Act of 1990 (OBRA ‘90)
•Have a high potential for abuse
•Currently accepted for medical use in the United States
•Abuse may result in severe psychological or physical dependence
•Prescriptions for must be written, not faxed or called in, except under certain specific guidelines
Schedule II
Today, ____________ must be supplied along with medications to ensure safe and effective use
package inserts (monographs)
The containers must not be able to be opened by 80% of children younger than age 5, but 90% of adults must be able to open them
The Poison Prevention Packaging Act of 1970
•Required that drug products, both prescription and OTC, must be effective and safe:
–Placed prescription drug advertising under FDA supervision
–Regulated qualifications of drug investigators
–Regulated manufacturers and their sites of operation
–Required more accountability from manufacturers
The Kefauver-Harris Amendment of 1962
•During the 1940s, the FDA began to use internal regulations to classify prescription (legend) drugs and nonprescription (over-the-counter or OTC) drugs
•Prohibited dispensing of legend drugs without a prescription
The Durham-Humphrey Amendment of 1951
__________is a discipline dealing with the ethical and moral implications of biological research and applications, especially as they relate to life and death
Bioethics
Also required registration of practitioners, documentation, and more restricted importation, sale, and distribution of opium
The Harrison Narcotics Act of 1914
If stolen or lost, the nearest DEA office must be notified, using DEA Form ______
DEA Form 106
Drugs that affect fewer than 200,000 Americans are referred to as orphan drugs
The Orphan Drug Act of 1983
•Have a low potential for abuse relative to those in Schedule III
•Generally include:
long-acting barbiturates
certain hypnotics, minor tranquilizers
Schedule IV
•When controlled substances become expired, DEA Form _________ must be used
•The pharmacist must write a cover letter:
–Explaining the situation
–Requesting DEA permission to destroy the substances
•Two witnesses must observe the destruction of the substances
DEA Form 41
•Have a high potential for abuse
•Not accepted for medical use in the United States
•Properly registered people may use these substances for research purposes
Schedule I
Ensures workplace safety and a healthy work environment
•Bloodborne Pathogens Standard requires rigid compliance to avoid exposure to body fluids and substances that may carry diseases such as HIV-AIDS and hepatitis B
The Occupational Safety and Health Act of 1970
•Placed ________ under the regulatory provisions of the CSA
•Hormonal substances that promote muscle growth that are used by athletes, sometimes illegally, to increase physical performance
The Anabolic Steroids Control Act of 1990
–Security and Electronic Signature Standards – mandates safeguards for physical storage and maintenance, transmission, and access to individual health information
–Privacy and Confidentiality Standards – limit nonconsensual use and release of protected health information (PHI)
HIPAA
•Created the Food and Drug Administration (FDA) and required pharmaceutical manufacturers to file New Drug Applications
•Required manufacturers to be concerned with purity, strength, effectiveness, safety, and packaging of drugs
The Food, Drug, and Cosmetic Act of 1938