mailing regulations
What federal law regulates controlled substances, including how they are mailed?
The Controlled Substance Act (CSA)
What are the five required parts of a legal prescription?
patient name, date, drug name/strength, directions (sig),and prescriber signature.
What is a patient package insert (PPI)?
Written information given to patients that explain how to safely use a medication.
What federal agency ensures that prescription drugs are safe and effective before approval?
The Food and Drug Administration (FDA).
What federal law classifies drugs into Schedules i-v?
The Controlled Substance Act (CSA).
Which federal agency must a pharmacy be registered with in order to legally mail controlled substances?
The Drug Enforcement Administration (DEA)
How many refills are allowed for schedule ii controlled substances under federal law?
ZERO REFILLS
Which type of medication is federally required to include a patient package insert every time it is dispensed?
Oral contraceptives.
What federal law requires drugs to be proven safe before being marked?
The Food,Drug, and Cosmetic Act.
Which schedule has the highest abuse potential and no accepted medical use?
Schedule i.
If a pharmacy mails prescription to another state, in which two must the pharmacy be licensed?
The pharmacy's home state and the patients state
Under federal law, schedule iii-v prescriptions may be refilled how many times within 6 months?
What is another FDA required patient information document for certain high risk medications?
A Medication Guide.
What state run program monitors controlled substance prescriptions to prevent abuse and diversion?
The Prescription Drug Monitoring Program (PDMP).
What form is required to order schedule ii controlled substances?
DEA Form 222.
What federal law protects patient privacy when mailing prescriptions?
HIPAA (Health Insurance Portability and Accountability Act).
For non-controlled drugs, how long is a prescription valid under federal law?
There is no federal expiration limit (state law determines it).
What type of information is included in a patient package insert?
side effects, warnings, directions for use, and precautions.
What FDA required safety program is used for medications with serious risks?
REMS (Risk Evaluation and Mitigation Strategy).
What is required on a controlled substance prescription to make it legally valid?
The prescribers signature.
If state law is stricter than federal law regarding mailing prescriptions, which law must the pharmacy follow?
The stricter law (usually the state law)
If state law differs from federal law regarding prescription regulations, which law must be followed?
The stricter law.
Which federal agency requires certain medications to include medication guides and patient package inserts?
The Food and Drug Administration.
If a prescription poses a safety concern under both federal and state law, which law must the pharmacy follow?
The stricter law.
What is required before a pharmacy can dispense controlled substances legally?
A valid DEA registration number.