Exam 2 Flashcards
Controls Federal CS Act
DEA
Enforces Texas CS Act
DPS/TBSP
Pure Food and Drug Act
Can’t be misbranded or adulterated
FDCA
SAFE (but not effective)
Kefauver-Harris
Safe AND effective
Response to thallidomide tragedy
Established GMP facilities
Established DESI
DESI established by?
Kefauver-Harris
Established GMP facilities?
Kefauver-Harris
Response to thallidomide tragedy?
Kefauver-Harris
Codeine concentration limits in C5
200 mg/100 ml (C5)
If more, then C3 (not C4)
Codeine concentration limits in C3
1800/100ml
Opioid concentration limits in C5
100/100ml (c5 federal)
50/100ml (texas)
Opioid concentration limits in C3
500/100ml (Federal and Texas)
Texas requires an Rx for codeine- containing product
True
Precursor to Federal CS Act?
Drug Abuse Control Amendments
Drug Price Competetion and Patent Term Restoration Act
Reduce HC costs
Patent 5 years
ANDA
Reduced HC costs?
Drug Price Competetion and Patent Term Restoration Act
Extended patent 5 years?
Drug Price Competetion and Patent Term Restoration Act
ANDA?
Drug Price Competetion and Patent Term Restoration Act
DEA 224
Needed for a pharmacy to dispense controlled substances
DEA 222
Ordering and transferring CIIs
Send 1 and 2 to Supplier
Supplier sends copy 2 to DEA
Pharmacy keeps copy 3
Anyone can fill, but only person with POA can sign it
DEA 106
Theft or significant loss; report in writing to DEA within one business day
Fill and send (within 2 months) to:
- DEA
- TSBP
- Police recommended
If unable to send out in 2 months, you can update TSBP and DEA.
DEA 41
On site destruction of a CS
- Record method of destruction
- 2 signatures of employees who witness
- Must leave irretrievable
Preferred method: delivery to a reverse distributor (treated as a transfer, if C2 use DEA 222, if C3-5, invoice)
Banned reimportation of Rx drugs made in US?
Prescription Drug Marketing Act
FDA Modernization Act
“Rx only”
Established REMS?
FDAAA
Required side effects statement?
FDAAA
Purple book
Therapeutic equivalence; interchangeable, bio-similars, pricing
Ex: Changing to a different BZD
Notify DEA about theft or significant loss in how much time?
1 business day
NDC
Manufacturer 4-5
Drug 4
Packaging Code 2
Orange Book
Generic equivalence
A- safe and effective
B- Do not use
Can do AA and AB
DEA can’t ask about what without consent?
Financial, sales, and pricing data (anything money related)
Practioners
MD DO DDS Podiatrist Vet
Mid-level practitioners
RN
PA
C3-5 only, C2 in some settings
Can’t change on a C2
Name of Pt
Name of Drug
Name of Prescriber
Date of Rx
Requires child- resistant container for Rx and certain OTC drugs?
Poison-Prevention and Packaging Act
