Mailing Regulations
Who can legally mail prescription drugs via USPS?
Licensed Pharmacists, medical practitioners, authorized dispensers
Federal Caution Statement
Labels must include: "Caution: Federal Law prohibits dispensing without a prescription" or "Rx only"
FDA approved easy to read handout that contains essential information like side effects, instructions on how to use, and who should not take the medication
What act places all substances into one of five schedules?
The Controlled Substance Act
What are the schedules Controlled Substances are placed in based on abuse risk?
Schedule 1- High risk, no medical use
Schedule 2- High risk but safe medical uses
Schedule 3,4,5- less risk of abuse, safe and accepted medical use, contain small amounts of narcotics.
How are Controlled Substances packaged to be mailed?
Pharmacy dispensed labels must be in plain language and easily readable is a state or federal regulation?
State
PPIs are strictly required for?
Oral contraceptives and estrogen containing products
What is the Federal Food, Drug, and Cosmetic Act?
Ensures consumer food is safe and sanitary, Drugs and devices are safe and effective for their intended uses
What are the penalties for mailing prescription drugs illegally?
loss of license, fines, criminal charges, and jail time
Federal Labeling Requirements
name and address of pharmacy, date of filling, NDC number, name of patient, name of prescriber, name of drugs, dosage form, strength, instructions on how to take medication, controlled substance warning
Are PPI requirements Federal or State?
Federal
What is the Kefauver-Harris Amendments of 1962?
strengthened the rules for drug safety and required manufacturers to prover their drugs' effectiveness.
What are the refills authorized for each schedule ?
Schedule 1- no medical use
Schedule 2- No refills allowed
Schedule 3,4,5- Up to 5 refills in 6 months
Who oversees mailing prescription drugs?
FDA, DEA, USPS, State Boards of Pharmacy
State Labeling Requirements
NDC number, date prescription dispensed, name if drug, dosage form, strength, name of prescribing practitioner, name of dispensing pharmacist, clear easy to read instructions, patient name, address, quantity dispensed
Must be provided to patients with each prescription
What is the Drug Supply Chain Security Act?
The FDA manages this to protect against counterfeit or tainted drugs within the US supply chain
What is the 28 day prescription rule for controlled substances?
There must be 28 days between refills of 30 day prescriptions
Which drugs cannot be mailed?
Investigational drugs, biologics, temperature sensitive, and prohibited drugs in destination area
Which agency regulates prescription drug labeling ?
FDA
What two bills were introduced in the 94th Congress to require PPIs?
The Rogers Bill, The Kennedy Bill
What is Post Market Safety?
FDA monitors for adverse effects, issues public health alerts, and manages recalls when safety risks are identified
How to dispose of Controlled Substances?
Facilities usually transfer substances to a DEA reverse distributor for destruction, facilities may destroy on site as long as they are rendered non-retrievable and must be witnessed by two authorized employees and documented using DEA form 41, partially used or broken substances are wasted using special devices like Rx Destroyer