Law 1
This law was enacted in response to unsanitary conditions in the meat packing industry in 1906 and was the first law that required that drugs be proven pure before they could be marketed
what is the Food and Drug Act (1906)
Both foreign and domestic drugs require approval by this agency before they can be marketed in the United States
How long in years all records for controlled substances must be maintained and readily available for inspection by the DEA or Board of Pharmacy
What is 2 years?
The class of drug recall issued when there is a strong likelihood of serious adverse reactions or death due to a medication.
What is a Class-I recall
This law allowed a patient to request that all of their prescriptions be placed in containers without safety closures
What is the PPPA of 1970 (Poison Prevention Packaging Act?
What is the Orange Book
what is the more strict or stringent law
This law allows a pharmacist to dispense sublingual nitroglycerin and metered dose inhalers without safety closures
What is the poison prevention packaging act of 1970?
This agency is responsible for issuing licenses to pharmacies, pharmacists and technicians, and for establishing requirements for reference materials in the pharmacy.
what is the BOP (Board of Pharmacy)
This paperwork must be provided to a patient the first time they fill a prescription in your pharmacy.
Due to OBRA '90, a pharmacy must offer ______________ to all Medicare and Medicaid patients picking up new prescriptions.
What is counseling?
This reference is used to look up Average Wholesale Pricing Information.
What is the Red Book?
The class of drug recall issued when there is little chance of a serious adverse event from a drug product
What is a Class III (3) drug recall?
This law made is legal for a physician to telephone a new prescription into a pharmacy
What is Durham Humphrey Amendment
This law required that health care providers protect the privacy and security of a patient's PHI
What is HIPAA?
This amendment to the Food, Drug and Cosmetic Act divided drugs into those that require a prescription and those that are Over-The-Counter.
What is the Durham Humphrey Amendment
These two items located on a manufacturer bottle of a medication are used to identify recalled drugs.
What are the NDC number and lot number
This reference is where one would check to see if taking two drugs together is safe or not.
What is Drug Interaction Facts
OSHA mandates that employees with potential exposure to blood borne pathogens be offered a vaccination for this disease at no charge.
What is a patient profile?
In response to the sulfanilamide tragedy that killed over 100 children in the 1930s, this law required that all drugs marketed in the United States be proven safe
What is the 1938 Food, Drug and Cosmetic Act?
The four phases of studies that must occur with human subjects in order to obtain final FDA approval of a drug are called this.
What are clinical trials?
Due to OBRA '90, this professional service that screens a patient's profile for contraindications, must be performed by a pharmacist before they fill a prescription for a Medicare or Medicaid patient.
What is prospective DUR
The organization that establishes the requirements for reference materials in a particular state.
What is the BOP or Board of Pharmacy
This was the first law that required drugs be proven pure, safe and effective before they were sold in the United States.
what is Kefauver Harris/the Kefauver Harris Amendment
This law requires that manufacturers provide SDSs (Safety Data Sheets) to accompany all hazardous substances that they sell
What is OSHA of 1970 (Occupational Safety and Health Act)?
Pharmacists and prescribers are required to access this system before prescribing or filling prescriptions for controlled substances in order to detect drug diversion.
What are PDMPs (Prescription Drug Monitoring Progams)? CRISP in Maryland
This is the length of time the signed HIPAA privacy policy acknowledgement must be retained by a pharmacy.
What is 6 years.
These are the two groups of people who are legally able to request that a prescription be dispensed with an easy open cap
Who are the prescriber and the patient?
This book is a compilation of manufacturer package inserts
What is the PDR?
Physicians' Desk Reference
This organization is responsible for ensuring that unwanted pharmaceutical and other chemicals do not contaminate the environment or our drinking water
What is the EPA (Environmental Protection Agency)
This is the organization that oversees Medicare and Medicaid.
What is CMS
(Center for Medicare and Medicaid Services)
What is 5 refills
This is the number of refills allowed on a C-II controlled substance.
What is zero
This is the number of refills allowed on a C-V controlled substance.
What is as many as the prescriber wrote
This is the best reference for stability, storage, purity and identification of a drug, and is the official compendium of pharmaceutical products in the United States.
What is the USP-NF
United States Pharmacopeia- National Formulary
This is the form used to order schedule C-II controlled substances.
What is DEA Form 222?
This is the minimum age allowed to purchase an exempt narcotic.
What is 18 years old.
This is the form used to report the loss or theft of a significant amount of controlled substances.
What is DEA Form 106?
When a pharmacy first registers with the local DEA office, they use this form.
What is a DEA 224?
DEA Form 41 is used to do this.
What is request permission to destroy unwanted C-II controlled substances?
What is an "A"?
This is the maximum amount of pseudoephedrine that may be purchased in a day.
What is 3.6 grams?
Drugs are divided into this many schedules by the Controlled Substance Act, based on their potential for abuse.
These kits must be available wherever antineoplastic medications are compounded, stored, delivered or administered
What are Chemo Spill Kits?
The middle four numbers in an NDC number indicate this.
What is the drug product?
This is the maximum amount of pseudoephedrine that may be purchased in a retail pharmacy without a prescription in a month.
What is 9 grams?
A drug rating in the Orange book that begins with this letter is not substitutable for the brand name product.
What is a "B"