The Food, Drug, and Cosmetic Act of 19____ required manufacturers to prove that their drugs were __________ before marketing.
1938, safe
The FDCA
... [Show More] was passed in reaction to what event?
sulfonamide tragedy
The Durham Humphrey Amendment of 19___ created what two categories of drugs?
1954, OTC and Rx
The Kefauver-Harris Amendment of 19____ required drugs to also be shown to be _____________ in response to what tragic event?
1962, EFFECTIVE in addition to safe, thalidomide tragedy
The Poison Prevention and Packaging Act of 19____ requires some household substances and drugs to use what?
1970, child-resistant packaging
The Hatch-Waxman Act of 19____ amended the FDCA to make it easier for what types of drugs to be marketed? To be FDA approved, these drugs must demonstrate: _____.
1984, generic drugs, quality and bioequivalence
The Prescription Drug Marketing Act of 19____ prohibited the sale of what items?
1987, to prevent diversion of drugs, it prohibited the sale of drug samples, re-imported drugs, and resale of drugs by healthcare organizations; also required wholesalers to be licensed by state
The Omnibus Budget Reconciliation Act (OBRA) of 19____ mandated what two pharmacy patient care requirements for Medicaid recipients?
1990, prospective Drug Utilization Review (DUR) and Patient Counseling
Which act defined the regulation and marketing of dietary supplements as food products? What year was it enacted?
Dietary Supplement Health and Education Act, 1994
The Prescription Drug User Fee Act of 19____ allowed the FDA to do what?
1992, FDA could charge fees to manufacturers for new drug approvals
The FDA Modernization Act of 19____ ensured the ability of pharmacists, under certain parameters, to continue to do what?
1997, allowed pharmacists to continue to compound; also created ClinicalTrials.gov
What act restricts pseudoephedrine and ephedrine sales? What year was it enacted?
Combat Methamphetamine Epidemic Act, 2005
The Drug Supply Chain Security Act of 20____ directed the creation of an electronic, interoperable national system to do what?
2013, track all drug products by 2023 including record of transaction info, transaction hx, transaction statement **Records must be kept X 6 years**
Pharmacy self inspection form; must be completed 30 days before opening a new pharmacy
Form #2550
Application for a new pharmacy
Application #609
(4) laws that must be present or immediately accessible in a pharmacy
DEA Regulations (21 CFR 1300), WI Pharmacy Laws (Stat. 450), WI Controlled Substances Act (Stat 961), WI Administrative Code
(5) resources required to be present in a pharmacy, at minimum
DI, counseling, generic substitution, compounding, calculations
Temperature requirement for fridge
36-46 degrees F
Temperature requirement for freezer
-13 to 14 degrees F
Temperature and humidity requirements for pharmacy
Max 40% humidity at 68 degrees F
Pharmacy closure form, which must be submitted to the board w/i 10 days of closing
Form #606
Closing pharmacy must notify the board of bankruptcy auction in writing at least _____ before the sale and provide the sale details and inventory with ________ after the sale
1 week, 10 days
How long of an absence would require the managing pharmacist to delegate their responsibilities to another pharmacist?
30 days
Pharmacy floor plan remodeling form, must be submitted to the PEB 60 days before remodel
Form #2866
How long after changing managing pharmacists must the PEB be notified of the change?
5 days
Remote dispensing sites must be inspected at least_______ and records must be kept for ______
monthly, 2 years
Form used to report lost or stolen controlled substances within 1 day of discovery to the DEA and within 2 weeks to the WI BOP
Form #106
Form used to report controlled substance destruction to the DEA
Form #41
The only records that may be stored off-site, as long as the DEA knows that location
Invoices and shipping forms
Narcotic Treatment Program DEA application form
Form #363
New application from for DEA registration
Form #224
Max amount of codeine allowed in a schedule III combo product with a non-narcotic
90mg/dosage unit or 1.8g (1,800mg) per 100mL or 100g
Max amount of codeine allowed in a schedule V combo product with a non-narcotic
200mg per 100mL or 100g
Schedule of Suboxone (buprenorphine/naloxone)
III
Schedule for codeine 60mg/APAP (Tylenol 3)
III for solid dosage form, V for liquid dosage form
Schedule for diphenoxylate/atropine
V
Schedule of morphine product w/ max of 50mg/100mL or 100g (0.05%)
III
Schedule of opium tincture
II
Schedule of opium product w/max of 25mg/dosage unit or 500mg/100mL (0.5%)
III
Schedule of opium product w/max of 100mg/100mL (0.1%)
V
Schedule of phenobarbital
IV
Schedule of pregabalin
V
Schedule of Robitussin AC (codeine + guaifenesin)
V
When are controlled substances inventoried?
Upon opening a new pharmacy, at least every 2 years (biennial), if drug is rescheduled (on national level)
(3) main responsibilities of pharmacists under the 2013 Drug Supply Chain Security Act (DSCSA)
Confirm entities you do business with are licensed/registered, maintain product tracing documents, and investigate illegitimate drugs
Who must pharmacists work with if drugs are suspected to be illegitimate?
Work w/ manufacturer to ensure pts. don't get illegitimate drugs, notify FDA, notify trading partners
(3) pieces of information that can NOT be changed on a controlled substance Rx (C II-V)
Pt. name, drug name, practitioner's signature ((but can modify strength, dosage form, quantity, date issued, pt. address, provider's DEA/address - all changes require pharmacist to date and initial the Rx including how they obtained the updated info) [Show Less]