Laws and Regulation Flashcards
Which of these laws states that all medication products must have directions for use and appropriate safety warnings?
A.) Poison Prevention Packaging Act of 1970 (PPPA)
B.) Federal Food, Drug, and Cosmetic Act of 1938 (FFDCA, FDCA, or FD&C)
C.) Pure Food and Drug Act of 1906
D.) Isotretinoin Safety and Risk Management Act of 2004
B. Federal Food, Drug and Cosmetic Act of 1938
The FFDCA requires all products to include a list of ingredients, directions, and safety warnings. It also states that all drugs must be approved by the FDA prior to being marketed and used by patients. The FFDCA improved upon the Pure Food and Drug Act by adding the safety requirements that the Pure Food and Drug Act was missing. The Isotretinoin Safety and Risk Management Act of 2004 addresses the need for Risk Evaluation and Mitigation Strategy (REMS) criteria and specific monitoring of patients using medications with potentially serious adverse effects. The PPPA describes the security requirements for medication packaging to prevent children from accessing the medication.
What does FDA class 1 recall mean?
medication is likely to cause severe adverse drug effects or even death
What does FDA class 2 recall mean?
medication may cause temporary adverse drug effects that are reversible
What does FDA class 3 recall mean?
medication is unlikely to cause the patient any adverse drugs effects
what is an acceptable way to store prescription drugs?
2 files: (CII) and (non-controlled + CIII-V)
2 files: (CII-V) and (non-controlled)
3 files: (CII) and (CIII-V) and (non-controlled)
What DEA form is used to order medication from a supplier?
DEA form 222
What form is used to register a retail pharmacy with the DEA?
DEA form 224
What form is filled out if medication is ever lost or stolen?
DEA Form 106
What form is filled out if one were to destroy a controlled substance?
DEA Form 41
How do you determine if a DEA number is valid?
There are 7 numbers
- add the even numbers
- add the odd numbers
- multiply the the total of the odd numbers by two
- add the sum of the number (odd number times 2) with the total of the even number
- the last number of the 7 number sequence should equal the end of the total
Is this a valid DEA number?
CG2467896
Yes
Is this a valid DEA number?
CG2467892
No
How long do prescription records need to be retained onsite by a pharmacy?
2 to 5 years, depending on the state
According to the Combat Methamphetamine Epidemic Act of 2005 (CMEA), what is the maximum amount of pseudoephedrine a customer can purchase in a 30-day period?
9 grams
Which of these can be performed by the pharmacist only?
A. maintaining medication inventory
B. compounding a prescription product
C. transferring a prescription via an unshared network
D. entering new prescriptions into the computer
C. transferring a prescription via an unshared network
Pharmacy technicians are able to perform all tasks in the pharmacy except: drug utilization review, patient counseling, transferring prescriptions (unless using a shared network), ordering and record keeping (all need pharmacist signature), and prescription verification (some states do allow tech-check-tech on a limited basis, however).
