PHARMACOLOGY: REGULATORY BODIES OF PHARMACY

if there is a potential harm to the public, who informs the public?

FDA

DEA has to do with

controlled substances

what are also two functions of the DEA?

Prosecute offenders who breach legislation.

Reduce the use of illicit drugs in the United States.

what does the FDA stand for?

Food and Drug Administration

what does the DEA stand for?

Drug Enforcement Administration

what does the TJC stand for?

The Joint Commission

what does the BOP stand for?

State Board of Pharmacy

what does the NABP stand for?

National Association of Boards of Pharmacy

what is MedWatch and who made it?

FDA made it

people can tell the FDA of any adverse effects that patients experience

what did the DEA make?

the five schedules

what does the joint commission do?

Provides accreditation programs for various healthcare facilities (ambulatory, behavioral health, acute care, critical care hospitals, labs, etc).

what is the state boards of pharmacy for?

(BOP) are those pharmacy boards that cater to the needs of their own state - establishing state-specific laws and regulations that influence and impact pharmacy and the safe use of medicines.

what is the BOP also responsible for?

More pertinently, the BOP is also responsible for certifying and licensing pharmacy personnel - which, in some states, includes pharmacy technicians.

What does the national association of the board of pharmacy do?

ensuring there are consistent standards among each state board.
However, the NABP does not have the force of law behind it.
Instead, it acts as a professional means to discuss the trajectory of pharmacy and how best to improve it on a state-by-state level.

Durham-Humphry Amendment

humpty dumpty cracked into two, one was broken everywhere and the other remained solid, so he called his friends to help

1951
Classified OTC vs Prescription
Required to have "legend" (Rx Only)
Prescriptive authority granted by state

also permitted prescriptions to be made over the phone

Kefauver- Harris Amednment

killing babies is keufar we have to control which drugs go out bro

The amendment sought to guarantee the safety, purity, and efficacy of both prescription and non-prescription medicines; eliminating the risk of dubious or harmful medicines being released into the public sphere.

Requiring that pharmaceutical manufacturing sites are registered and permit inspections as and when these inspections are needed.
Placing drug advertising under the remit of FDA supervision.

poison prevention packaging act

PPPA
- requires use of child resistant packaging for prescription drugs, OTC, household chemicals, and hazerdous materials
- some drugs are exempt from child proof packaging --> OTC drugs with the proper labeling not for children and in big enough packages