mailing regulations
What type of mailers are able to send out prescriptions legally?
Which federal regulation sets the minimum standards for prescription drug labeling?
The FDCA (The Food, Drug, and Cosmetic Act).
What drug class is federally required by the FDA that must be provided for specific medications, including estrogen- containing products and oral contraceptives.
PPI's (Proton Pump Inhibitors).
What federal regulatory has drug approval and Post- Marketing Monitoring when reviewing drugs before they hit the market and continues to monitor them for side effects through the MedWatch program?
The FDA (Food and Drug Administration) which allows healthcare providers and patients to report adverse events.
The CSA is the federal law governing what?
The Controlled Substance Act primarily governs the manufacture, importation, possession, use, and distribution of certain substances.
What are the packaging standards for medications when they are mailed out?
Outer wrappers must be plain and free of markings that disclose the contents.
What is usually the required federal label to put on a controlled substance medication (C-II - IV) to warn patients from giving their medication to someone who is not prescribed to it?
The required label will state, "Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed."
What is a federally required PMI sheet?
A Patient Medication Information sheet is documents standardized into a one page sheet for the patient to read and comprehend the medication
REMS means Regulatory Evaluation and Mitigation Strategies, and the FDA mandates certain high risk medications.
The DEA classifies drugs into how many schedules and what do they mean?
They are scheduled into 5 schedules:
C-I: High abuse potential, no medical use.
C-II: High abuse potential, medical use.
C-III-V: Lower potential for abuse, medical use.
No, the state of Texas prohibits pharmacies from accepting the return of a prescription for reuse to prevent tampering.
Which regulation is in charge of manufacturing and pharmacy labeling?
The FDA.
What is a federal IFU?
Instructions For Use, for drugs that have a complex administration.
The DEA Drug Enforcement Administration.
Federal Mandates that prescribers must have what when dispensing medications?
Federal law mandates specific prescription requirements, such as the provider’s signature and DEA number.
The state of Missouri requires pharmacies to have written policies protecting medication from being in extreme temperatures during shipment.
What is a federal requirement for a pharmacy serial number?
What is the pharmacist required by the states to hand the patient when dispensing their medication?
A Patient Packaging Insert.
What is a state required PDMP check?
Prescription Drug Monitoring Program, Many states require prescribers and pharmacists to query the PDMP before dispensing opioids, benzodiazepines, and other high-risk, controlled substances.
What is mandatory E-Prescribing and what does it mean for state regulations?
E-Prescribing is when a prescriber online who is licensed can send a prescription for controlled substances to a pharmacy, this means for state regulations that it may reduce fraud.
Can pharmacies transfer prescriptions to be filled at another pharmacy?
Yes, pharmacies may transfer prescriptions and refills to another pharmacy under specific conditions.
What are some additional state law requirements?
Manufacturing name, generic substitutions, and expiration dates.
What is a state liability for package inserts to show that the information was provided to the patient?
While these inserts are not generally considered to establish a standard of care in medical malpractice, they are heavily used in litigation to show what information was provided to the patient.
The Food and Drug Administration requires there to be a Black Box warning for serious risk medications which could mean suicide risk, cancer risk, etc.
What does a PMP help states maintain?
Prescription Monitoring Programs help states track prescriptions for controlled substances to help clinicians identify "doctor shopping" and prevent overdose.