mailing regulations
This service is required by the U.S. Postal Service to ship controlled substances to ensure both security and tracking.
Registered Mail
This key piece of information is included on a prescription label
the drug name and strength
(patient's name is also acceptable)
These types of drugs require a patient package insert (PPI) to ensure patients are informed about the risks and benefits of the medication.
oral contraceptives or estrogen-containing drugs
This federal agency is responsible for overseeing the safety of drugs, ensuring that they meet safety standards before they reach the market.
the Food and Drug Administration (FDA)
This classification of drugs is subject to the strictest federal regulations, including the requirement for a written prescription.
Schedule II controlled substances
This federal agency requires pharmacies to comply with the mailing rules when sending prescription medications, including controlled substances.
the Drug Enforcement Administration (DEA)
What is a NDC number
10 or 11-digit number that is used to identify drugs on medication packages and inserts, and to report prescription drugs in pharmacy transactions.
the main purpose of a Patient Package Insert (PPI) in relation to a medication.
to provide important safety and usage information for the patient
This type of program is designed to monitor the safety of drugs after they are approved, allowing for reporting of adverse events.
the FDA’s MedWatch program
This federal act regulates the distribution, dispensing, and storage of controlled substances
Controlled Substances Act (CSA)
Under the Ryan Haight Online Pharmacy Consumer Protection Act, it is illegal to mail this type of prescription unless a valid prescription is obtained.
controlled substance
The FDA requires this on prescription drug labels to inform patients of potential adverse effects.
"warning" or "precaution" statement
Patient Package Inserts (PPIs) must be written in this manner to ensure the information is clear and understandable to the patient.
plain language or layperson-friendly language
This term refers to the official system in which adverse events and drug interactions are reported to the FDA.
Adverse Event Reporting System (AERS)
In many states, this action must be taken when dispensing a controlled substance prescription to ensure compliance with state regulations.
the recording or tracking of the prescription in a state prescription monitoring program (PMP)
This type of packaging is required for mailing prescription drugs to ensure they are not tampered with or easily opened.
tamper-evident packaging
State law typically requires pharmacies to include the prescriber’s ______ on the prescription label, which can be verified for contact.
phone number
PPIs are required to be given to patients when these types of drugs are dispensed, particularly when the drugs have serious or potentially life-threatening side effects.
new drugs or drugs with significant risks
This program was created by the FDA to ensure that patients using medications with serious side effects are closely monitored and followed up after prescribing.
REMS (Risk Evaluation and Mitigation Strategy)
This federal agency is responsible for enforcing the Controlled Substances Act and monitoring illegal distribution of controlled substances.
Drug Enforcement Administration (DEA)
The U.S. Postal Service prohibits the mailing of prescription drugs to these types of locations due to concerns over abuse and illegal activity.
P.O. Boxes
Federal regulations mandate this piece of information on prescription labels to ensure the medication is used as intended and to reduce misuse.
the quantity or number of tablets prescribed
This U.S. federal agency requires the distribution of Patient Package Inserts for certain medications, especially those with significant safety concerns.
the Food and Drug Administration (FDA)
This label on prescription drugs must be provided to the patient, outlining the potential risks, benefits, and how to handle any adverse reactions.
the Medication Guide
When prescribing Schedule III, IV, or V controlled substances, this method of prescription is allowed, as opposed to Schedule II
verbal prescription or electronic prescription