Pharmacy Laws Pt. 1: Federal Requirements Flashcards
(32 cards)
How many numbers are in an NDC number?
11
What’s the meaning of the first 5 number in an NDC number?
The manufacturer of the drug.
What do the 4 middle numbers in an NDC number mean?
Dose/Strength
What do the last 2 numbers in an NDC number mean?
Pack Size
If the first five numbers in an NDC number is only 4 numbers, then what do you do?
Add a zero in the front of the number sequence. Same goes for the 2nd four numbers and the last two numbers.
What do you need to let someone pick up a drug?
The patient’s first name, last name, and birthday.
What do you need in order to dispense controlled substances?
An ID and proof that the person is 18.
What does it take to pick up Pseudophed? Why?
An ID because Pseudophed can be used to make meth.
How often do you have to renew your National LIcense?
Every 4 years.
How many hours of continuing education do you need to watch in order to keep your National License?
22 hrs.
What form is ordered to use CII Medications?
DEA Form 222, also can done electronically through CSOS
Is CJ6458913 a valid DEA number?
It is not valid because it does not end in 6.
The maximum amount of pseudoephedrine that can be purchased in a single transaction is ____.
3.6 grams
What is an SDS?
Safety Data Sheet
What does the Safety Data Sheet outline?
The appropriate storage, handling, and clean up procedure for a hazardous product.
What did the Combat Methamphetamine Epidemic Act of 2005 do?
It limits the amount of pseudophedrine that can be purchased by an individual customer.
How many grams of Methamphetamine can a customer get in a 30 day period?
9 grams
What law requires all products to include a list of all ingredients?
Federal Food, Drug, and Cosmetic Act of 1938 (FFDCA)
What does the Federal Food, Drug, and Cosmetic Act of 1938 (FFDCA) require on all drugs?
1.) a list of ingredients, directions, and safety warnings.
2.) All drugs must be approved by the FDA prior to being marketed and used by patients.
3.) the labeling requirements for all prescription and over-the-counter medications.
What is misbranding?
When a product is misinterpreted on its label
What counts as misbranding on a drug?
1.) if the drug is misrepresented on the label.
2.) If the drug contains unapproved color additives or ingredients.
3.) If the drug does not show the warnings and labeling required by the FDA
When is a product considered adulterated?
1.) If it is a different strength
2.) If it was made in unsanitary conditions
3.) If it is not compliant with purity standards.
What is the REMS program?
The Risk Evaluation and Mitigation Strategies program between the FDA and the manufacturers.
What does REMS do?
It limits inappropriate dispensing and protects customers.
