pharmacy law Flashcards
This act limits the transport of opium. In order to purchase opium, a prescription is required
1914 Harrison Narcotic Act
This act prohibits the sale of adulterated or mislabeled food, drinks, and drugs
1906 Federal Food and Drug Act
This act made the Food and Drug Act more comprehensive to include cosmetics. The act also defines misbranding or adulteration of drugs to be illegal
1938 Food Drug and Cosmetic Act
-requires drug companies to provide package inserts
1938 Food Drug and Cosmetic Act
-requires that a habit-forming drug to be labeled “may be habit forming”
1938 Food Drug and Cosmetic Act
-requires that a new drug has to be proven safe under FDA guidelines before marketing
1938 Food Drug and Cosmetic Act
This act distinguishes legend drugs(prescription) from over the counter drugs (otc)
1951 Durham Humphrey Amendment
Requires companies to label legend drugs “Caution: Federal law prohibits dispensing without a prescription”
1951 Durham Humphrey Amendment
Requires physician supervision for the purchase of legend drugs
1951 Durham Humphrey Amendment
over the counter drugs without medical supervision are required to have certain information on box
1951 Durham Humphrey Amendment
- product name
- name and address of manufacturer and/or distributor
- active ingredients
- quantities of all other ingredients whether active or not
1951 Durham Humphrey Agreement
All drugs made from 1938 forward have to be proven safe and effective
1962 Kefauver-Harris Amendment
Requires “good manufacturing practices” gmp
1962 Kefauver-Harris Amendment
Stricter requirements are now placed on drug manufacturers seeking drug approval; manufacturers have to prove their drug to be safe and effective before marketing it
1962 Kefauver-Harris Amendment
FTC(Federal Trade Commission), not the FDA, now handles drug advertisement
1962 Kefauver-Harris Amendment
Requires that a manufacturer must:
- Register annually
- Report any adverse reactions
- Be inspected every two years
1962 Kefauver-Harris Amendment
Drug Enforcement Agency(DEA) was formed which is a unit of the Justice Department. The controlled substances are now placed into schedules I-V which are based on abuse potential.
1970 Comprehensive Drug Abuse Prevention and Control Act(Controlled Substance Act)
This act requires childproof packaging on most drugs dispensed in a pharmacy
1970 Poison Prevention Packaging Act
This act enables the FDA to promote the research and marketing of drugs needed for the treatment of rare diseases
1983 Orphan Drug Act
These drugs are made for such a small percentage of the population that the drug’s demand does not make marketing and manufacturing in large quantities economically feasible
1983 Orphan Drug Act
This act streamlines the process for granting approval of generic drugs
1984 Drug Price Competition and Patent-Term Restoration Act (Hatch-Waxman Amendment)
Gives manufacturers incentives to develop new drugs by giving patent extensions
1984 Drug Price Competition and Patent-Term Restoration Act (Hatch-Waxman Amendement)
This act allows generic drug companies the ability to rely on safety and efficacy findings of an innovator’s drug after the expiration of the patent
1984 Drug Price Competition and Patent-Term Restoration Act (Hatch-Waxman Amendment)
This act established the FDA as an agency of the Department of Health and Human Services
1988 Food and Drug Administration Act
Banned the sale, trade, or purchase of drug samples
1988 Prescription Drug Marketing Act
This act requires a pharmacist to attempt or offer to counsel patients on all new prescriptions
1990 Omnibus Budget Reconcilliation Act (OBRA)
This act requires pharmacists to provide information on any drug being dispensed such as: name and description of the medication, and how much of the medication should be taken, side effects, contraindications, interactions, adverse effects of the medication, storage, refill information and what to do if a dose is missed
1990 Omnibus Budget Reconcilliation Act (OBRA)
This act created rules and regulations regarding the privacy and security of patient health information
1996 Health Insurance Portablility and Accountability (HIPAA)
This act provides limitations stating who can access, distribute and receive patient health information
1996 Health Insurance Portability and Accountability Act (HIPAA)
This act makes health insurance portable for employees switching jobs.
1996 Health Insurance Portability and Accountability Act (HIPAA)
This act includes provisions that make health care information more cost effective and efficient by requiring standardized electronic transmissions of claim information
1996 Health Insurance Portability and Accountability Act (HIPAA)
This act limits the purchase of pseudoephedrine products to 3.6g of pseudoephedrine per day or 9g per 30 days
2006 Combat Methamphetamine Epidemic Act (CMEA)
An attempt must be made to notify the patient that the drug they may be taking could cause serious harm or death
Class I Recall
The probability of serious harm is not likely and the effects may be temporary or reversible. This recall does not go to the customer level and is usually due to problems with consistency of potency
Class II recall
Not likely to cause any serious adverse effects and does not go to the customer level
Class III recall
- Description of the drug
- Clinical Pharmacology
- Indications and usage
- Contraindications, precautions, warnings and adverse reactions
- Drug abuse, dependence and overdosage information
- Dosage, administration and how the drug is supplied
- The date of the most recent labeling revision
Package inserts must contain
- Oral contraceptives
- Estrogen-containing and progestational drugs
- Intrauterine contraceptive devices
- Diethylstillbestrol products
- Accutane
- Metered-Dose inhalers
Package inserts must be distributed with the following drug classes:
The first five numbers of an NDC identify:
the manufacturer
The next four numbers identify:
a specific drug made by the manufacturer
The last two numbers of NDC identify
the package size
- These drugs have no accepted medicinal use in US
- These drugs have the highest abuse potential
Schedule I Drugs
- these drugs may not be refilled
- the ordering of these drugs require a DEA 222 form
- the returning of out of date drugs require a DEA 222 form
- these drugs have a high abuse potential that may lead to severe physical or psychological dependence
Schedule II drugs
- these drugs may be refilled 5 times in a 6 month period
- these drugs have less potential for abuse or dependence than a Schedule I or II drugs
Schedule III drugs
- These drugs may be refilled 5 times in a 6 month period
- these drugs have less potential for abuse or dependence than Schedule II or III drugs
Schedule IV drugs
-these drugs have less potential for abuse or dependence than Schedule II, III, or IV drugs
Schedule V drugs
Used for the purchasing and returning of outdated CII drugs.
DEA form 222
Used to report lost or stolen controlled substances.
DEA 106 form
Used to document the destruction of controlled substances.
DEA form 41
This form is needed for a pharmacy to dispense controlled substances
DEA form 224
This form is needed to operate a controlled substance treatment program or compound controlled substances
DEA form 363
This form is needed to manufacture or distribute controlled substances
DEA form 225
compares therapeutic equivalency of drugs using an alphabetical rating system. This book determines if drugs can be substituted in place of others. A can be-B cannot
Orange book(FDA’s approved drug products publication)
This book contains a comprehensive listing of drugs and comparative drugs. Drugs are organized by therapeutic class and provide general information with a list of monographs.
Drug Facts and Comparisons
This book gives a listing of drugs by pricing, strengths, sizes, manufacturers, brands, and generics
Drug Topics Red Book
This book lists injectable drug information such as compatability, storage and dosages
Handbook on Injectable Drugs
This book contains packet insert drug information intended for physicians and is published annually. It contains color pictures with a list of drug manufacturers including their addresses and phone numbers.
Physician’s Desk Reference(PDR)
This book lists generic drugs in alphabetical order. It also contains additional drug info
Mosby’s Complete Drug Reference
Drugs are listed alphabetically and provide brand, generic and the chemical names of the drugs. It gives a list of manufacturers, strengths and dosage forms of the drugs listed
American Drug Index
This book is used to determine the compatibility of medications that will be used in an IV bag. This book shows the compatability, solubility and stabililty of medications
The Handbook of Injectable Drugs
Provides information on hazardous materials that may be in the pharmacy and also provides information on disposal, storage, safe use and clean-up of the medications
Material Safety Data Sheets (MSDS)
