Omnibus Budget Reconciliation Act of 1990
The law requiring pharmacists to perform a prospective drug review, provide patient counseling, and maintain patient records
Safety Data Sheet (SDS)
Resource of information about the hazards of products and safety precautions
Twelve months
How long prescriptions of non-controlled medications are valid
All controlled substances are permitted to be mailed
Reguarding mailing controlled substances via the US Postal Service
Package size (and type/ package code)
The third segment of an NDC number
Every two years
Frequency at which the pharmacy must complete an inventory of controlled substances
(USP) 795
Chapter of United States Pharmacopeia provides guidance for the compounding of
non-sterile
formulations for human or animal administration
(USP) 797
Chapter of United States Pharmacopeia provides guidance for the compounding of
sterile
formulations for human or animal administration
(USP) 1160
Chapter of United States Pharmacopeia provides guidance for pharmacutical calculations
(USP) 1176
Chapter of United States Pharmacopeia provides guidance for prescription balances and volumetric apparatus
Class 3 recall
A drug recall in which the use or exposure of the violative substance
is not likely
to cause adverse health consequences
Class 2 recall
A drug recall in which the use or exposure of the violative substance
may
cause adverse health consequences
Class 1 recall
A drug recall in which the use or exposure of the violative substance
will cause serious adverse health consequences/death
USP (United States Pharmacopeia)
The organization which develops standards regarding the identity, strength, quality, and purity of medications and dietary supplements
In an emergency situation
An oral order for a schedule 2 controlled substance is permitted
The Joint Comission
The organization evaluates and accredits health car organizations and programs in the US
Schedule 1
Medications that have no currently accepted medical use and a high potential for abuse are in what drug schedule
Food, Drug, and Cosmetic Act of 1938
Grants authority to the FDA to oversee the safety of food, drugs, and cosmetics. Requires that bew drugs must be proven safe and have FDA approval granted prior to marketing
(Act)
Pure Food and Drug Act of 1906
Preventing manifacture, sale, and transport of adultered drugs
(Act)
Durham-Humphrey Amendment of 1951
Habit forming/ harmful drugs must be dispensed under MD supervision. Seperated drugs into prescription and over-the-counter categories
(Amendment)
Controlled Substances Act
Regulates C2 (Act)
The pharmacy is out of stock of the particular medication
It is okay to partially fill a schedule 2 controlled substance if
Strenght, dosage form, and formulation (product code)
The second segment of an NDC number
Thirty days
A prescription for a schedule 2 controlled substance must be filled within how many days of the date written
United States Pharmacopiea
This reference books is required to be in every pharmacy
Class 2 Biological Safety Cabinet (Vertical Laminar Flow Hood)
Chemotherapeutic/ cytotoxic agents should be prepared in
Compounding Aseptic Isolator
Non hazardous drugs may be prepared in
Sublingual Nitroglycerin Tablets
Medication exempt from the requirements of the Poison Packaging Act of 1970
Drug manufacturer (labeler)
The first segment of an NDC number
Comprehensive Drug Abuse Prevention and Control Act of 1970
This law classified controlled substances into one of five categories based on their abuse potential and accepted medical use
Health Insurance Portability and Accountability Act of 1996
This law established the provision that all patient medical records and ither personal health information must be kept private
Pseudoephedrine, ephedrine, and phenylpropanolamine
The Combat Methamphetamine Epidemic Act of 2005 regulates the sale of over-the-counter products containing (3)
Prescription Drug Marketing Act of 1987
Legal safeguards for prescription drug distribution to ensure safe and effective pharmacuticals. Prohibits the reimportation of drugs into the US and regulates the sale of samples (act)
Hatch-Waxman Act of 1984
Encourages manufacture of generics (act)
Resource Conservation and Recovery Act
Governs disposal of solid waste and hazardous waste (act)
One time
Prescriptions for drugs in schedule 3-5 may be transferred between pharmacies this many times
Environmental Protection Agency
Regulatory agency which establishes guidelines for the disposal of hazardous waste
Annually
According to USP 797, pharmacy personnel who compound low- and medium-risk level sterile products must have their aseptic technique evaluated this often
Food, Drug, and Cosmetic Act of 1938
A drug label that does not contain adequate directions for use would be in violation of this federal law (act)
Product name and quantity, purchaser name and address, date and time of sale
The Combat Methamphetamine Epidemic Act of 2005 requires that the logbook of pseudoephedrine sales includes these (3)
Controlled substances
Prescribers mist have a DEA number in order to write prescriptions for these
The purchaser must complete the Exempt Narcotic Book, no more than 1 container can be sold to the same purchaser within a 48-hour period, the product must be sold in the original manufacturer's container
The following are required for the over-the- counter sale of select shedule 5 medications
Five
No more than _____ refills are permitted for a schedule 3-5 controlled substance prescription
Form 222
The DEA form used to order schedule 2 medications
Six months
According to federal law, prescriptions for non-controlled medications must initially be filled within __________ of the date written
Each prescription must be issued on a separate prescription blank, the prescriber must indicate the earliest day each prescription can be filled, and the issuance of multiple prescriptions must be permitted by applicable state laws
All of the following is true regarding the issuance of multiple prescriptions for a particular schedule 2 controlled substance from a prescriber to a patient (3)
Same route of administration
Generally, a generic substitution can be made for a drug if the generic product meets the following criteria
72 hours
Pharmacy records such as prescriptions, controlled substance inventory records, and invoices must be able to be retrieved within how long of a request
Center for Medicare/ Medicaid Services (CMS)
The federal agency which administers the Medicare abd Medicaid programs
Orange Book
Information on the generic equivalence of drugs can be found in this resource