SubChapter A 2501 Prescription Drugs and Devices Wording from the Food Drug and Cosmetic Act Note what dispensing is Misbranding is Adulterated is Can you possess these Expired drugs are kept where ID: 719214
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Slide1
The LAC: PharmacistsSlide2
Chapter 25
SubChapter
A
2501 Prescription Drugs and Devices
Wording from the Food Drug and Cosmetic Act
Note what dispensing is
Misbranding is
Adulterated is
Can you possess these?
Expired drugs are kept where?
Recalled drugs
What class is which
2503 Drug Returns
Once they leave, they are not yours
Well, this is not completely true. Read On.Slide3
Chapter 25, A
2505 Investigational Drugs
So these are research only drugs
2507 Veterinary Prescription Drugs
Labeling
Storage
2509 Prescription Devices
Syringes
So an embalmer can sell syringes?
Storage
Couple of folks mentioned exchange programsSlide4
Chapter 25, B
2511 Prescriptions
Written Prescriptions
Size Matters
Note what goes on it
Midlevel must have MD info on script
Max orders per script
Equilivalent
Drug Product Interchanges
Note rule for
medicaid
/
medicare
If DAW is checked, don’t ask don’t tell
Issue with ins charges for new generics
Oral Prescriptions
Note in this section it does not mention technicians?
Electronic Prescriptions
This definition presents an issue in Chap 27
Fax outside of pharmacy?Slide5
Chapter 25, B
2513 Prescription Receipt and Verification
Oral – Remember the tech could write the oral Rx down…
Electronic – Does note require a hard copy, here..
2515. Prescriptions Based upon Electronic Questionnaires
Naughty, Naughty pharmacist/physicians
2517 Prescription dispensing
What are the six things?Slide6
Chapter 25, B
2519 Prescription Refills
Note the requirement for a new RX number
Note rules for controls
2521 Emergency Refills
‘Practitioner is not available’
2523 Transfer of Prescription Information
Controlled Substances
Transfers only once
Well, unless you share a real, time database
What information do you need!!!
Non-Controlled SubstancesSlide7
Chapter 25, B
2525 Prescription Expiration
Script expires after 1 year
Unless controlled six months
2527 Prescription Labeling
Yeah, know these
2529 Pharmacy Prepackaging
Note what goes on the label here!Slide8
Chapter 25, C
SubChapter
C: Compounding of Drugs
2531 Purpose and Scope
2533 DefinitionsSlide9
Chapter 25, C
2535. General Standards
Duplicate products
Written procedures
Beyond use date
Anticipated Use Products
Labeling
2537 Requirements for Compounding of Sterile Products
Note the use of ‘pharmacist in charge’ more on that in Chap 11
Note CE requirementSlide10
Chapter 25, C
2537 Requirements for Compounding of Sterile Products, moreSlide11
Questions
This slide reserved for future use!