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what does FDA stands for
Food and Drug Administration
what does the FDA do
- Approve new drugs to be sold in the US
- Process New Drug Applications (NDA)
- Regulate package inserts
- Regulate advertising of drugs
- Issue recalls
Who regulates Pharmacy in the US
- The Joint Commission
what does DEA stands for
Drug Enforcement Agency
what does the DEA do
- Enforce the CSA (controlled substances act)
- Track controlled substances manufactured and sold
- Investigates all violations involving controlled substances
- Set the DEA Sch. Definitions
- Issue DEA Numbers
what does BOP stands for
Board of Pharmacy
what does the BOP do
- Regulate licensing of Pharmacists
- Regulate licensing of Pharmacy Technicians
- Set state laws / requirements
- Outline the operating guidelines in the pharmacy
- Investigate violations of the operating guidelines
- Determine state regulated controlled substances*
what does the The Joint Commission do
- Watches over Healthcare Organizations
- Third Party Auditors / Regulators for insurance Providers
what does NDA stands for
New Drug Application
what are the New Drug Initial Developments
- Investigational New Drug Review
what does the Pre-Clinical process involves
Pre-Clinical animal testing
what does the Investigational New Drug Review process involves
- Review of of Pre-clinical Trial results.
- Determination of safety to use on humans.
- Authorization to ship across state lines.
New Drug Clinical Trials phase i involves
- a small number of healthy volunteers (25-100).
- Safely tolerated dosages determined.
- Identification of major side-effects
- Emphasis on safety and maximum tolerated dosages.
New Drug Clinical Trials phase ii involves
- many more volunteers (100-300).
- Emphasis on the drugs effect against what it's designed to treat.
- Effects compared with similar patients receiving different treatments.
New Drug Clinical Trials phase iii involves
- a few more volunteers (300-3000).
- Emphasis on the drugs overall effect.
- Effects compared with patients unknowingly taking placebos
- Study of different populations and different dosages.
- Testing the drug in combination with other drugs.
- Final Phase before presenting to FDA for approval.
New Drug Post Approval Trials is phase iv and involves
- Ongoing/Post approval trials.
- Health-care professionals to report any adverse findings.
- This phase lasts eternally, as long as the drug is on the market.
what is the New Drug Application process
- New Drug Initial Development
- New Drug Clinical Trials
- New Drug Post Approval Trials
how long does the new application process Time takes
This process can usually take 12-15 years. The time elapsed from a drugs discovery in a lab until it becomes available to market to the general public can be even longer
How long does a drug Patent last and the time it starts
a Patent only lasts 20 years and starts from the time the application for patent was filed
Who are the DEA
a branch of the U.S. Department of Justice. Their mission is to enforce the Controlled Substances Act. In pharmacy, they monitor a closed system of distribution for controlled substances
what are Schedule i drugs
drugs with No accepted medical use. Extremely high potential for abuse. High potential for psychological and physical dependency.
what are Schedule ii drugs
drugs that have medical use. High potential for abuse. Relative potential for psychological and physical dependency.
what are Schedule iii drugs
drugs that have medical use. Moderate abuse potential exists, but less than Sch II.
what are Schedule iv drugs
they have Abuse potential, but less than Sch III
what are Schedule v drugs
drugs with the Lowest abuse potential of the DEA Sch.. Abuse potential exists, but less than Sch IV
when are D.E.A. Form 222 used
whenever Sch I or II drugs are bought, sold or transferred between pharmacies or qualified distributors
where do you get the D.E.A. Form 222 and what happens if you make a error filling out the form
The forms are only available through the DEA and errors are not acceptable on the form. In the case of an error, the form must be voided and kept on file and a new form used
how do you verify a DEA number
- -add the 1st, 3rd and 5th number
- -then and the 2nd, 4th, and 6th number and multiply the result by 2
- -take the ans. from both equation and add them together
- -the sencond digit in the ans should match the last digit of the DEA number
** the fist letter of the DEA number represents the type of practice or institution the DEA number is issued to and the second letter represents the first letter of the practitioners last name**
what is the FDA recall definition
Recalls are actions taken by a firm to remove a product from the market. They may be conducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority
what determines the class of a recall
The urgency and severity of anFDA Recall is what determines the "class" of the recall
when would a class i FDA recall be issued
Would be used in a case where there is a probability that, the use of or exposure to a violative product will cause serious adverse health consequences or death.
when would a class ii FDA recall be issued
Would be used in a case where use of a violative product may cause temporary health problems and the probability of serious adverse health consequences is remote.
when would a class iii FDA recall be issued
May be used in a situation in which use of a violative product is NOT likely to cause adverse health consequences, but has violated some FDA regulation.
what is the FDA Market Withdrawal
Withdrawal when a product has a minor violation that would not be subject to FDA legal action. The manufacturer must remove the product from distribution markets or correct the violation
what is the FDA Medical DeviceSafety Alert
Safety Alert Used only for medical apparatus equipment. This is when a medical device may present an unreasonable risk of substantial harm. In some cases, these situations also are considered recalls.