Day 1- Pharmacy Law Flashcards
What is the limit on controlled substances per prescription?
How do you hand wash in USP 797?
Do you always need to document stuff annually?
No limit on number 3-5.
30 seconds, all the way up to forearms.
YES
What are your 2 records in USP 797?
What is CSP low risk?
What is CSP high risk?
Master formulation and compounding record.
ISO 5 and only sterile ingredients, not more than 3 products and not more than 2 entries into any sterile container. BUD is 48 hours at controlled room temp, 14 days refrigerated, 45 days frozen.
Compounding sterile from non steril ingredients. BUD is 24 hours at controlled room temp, 3 days refrigerated, 45 days frozen.
What is CSP medium risk?
When do you reevaluate your aseptic technique?
What is the Utah law for inventory records vs DEA and when do you file them?
Multiple or small doses of sterile products, BUD is 30 hours at controlled room temp, 9 days refrigerated, 45 days frozen.
prior to initiation of compounding and then annually for low and medium, semi annually for high risk.
5 years keep and DEA is 2. Go with 5. Inventory records should be filed separately from all other records.
When do you need to remove expired medications?
When can a controlled substance be transferred?
Do you need to put stickers on opiod about overdose and have information pamphlets?
At regular intervals.
For the purpose of refill dispensing between pharmacists. EPCS 2-5 can be transferred. Original C2-C5 can’t be transferred.
Yes! For C2 and C3 opioids.
How often do you clean the compounding area?
What are your rules for controlled substance inventory taking?
What is your beyond use date if the ingredients didn’t have an expiration date?
ISO-5 at beginning of each shift, before each batch, every 30 minutes during continuous compounds, after spills, and when surface contamination is known or expected. Counters and easily cleanable work surfaces and floors daily. Walls, Ceiling, and Shelves monthly. No cleaning when compounding is taking place.
Shall be within 12 months following the inventory date of each year and may be taken within 4 days of the specified inventory date. C1’s and 2’s shall be separate from 3,4, and 5.
3 years. Unless you have USP 795 proper documentation.
How many techs/interns can access the CSD on behalf of the pharmacist?
How much training does someone require on long acting injectables?
What are your rules for dispensing an opiate antagonist?
5.
2 hours.
Follow protocol, report on an annual basis to the division and the physician who issued the standing order no later than 15 days after December 31st. 10 days for UDOH.
Can you transfer charitable drugs?
Who can get a temporary license?
What changed with the 1:3 rule?
Permit an legible donor to transfer an eligible prescription drug to an eligible pharmacy.
licensed, in good standing, to practice pharmacy in another state or territory of the United States.
Doesn’t matter anymore, just as long as you don’t put someone at risk, but you can’t have more than 1 pharmacy tech in training.
What is the legal amount of interns?
What is the new laws on PBM’s and their prices?
What is the new birth control law in Utah?
2 during a working shift and 5 at a public outreach event.
No GAG order anymore(aka must tell patient if cash is cheaper), provide explanation of DIR fees and how to avoid them in the future.
Pharmacists have a standing order, must be 18, complete questionnaire, appointment with provider every 24 months.
How often do nonsterile compounding areas need to be cleaned?
How often should equipment be checked?
What are the BUD’s and Storage temps for the different types of compounds?
Floors–> daily. Ceilings, Walls, Storage Shelving–> every 3 months. Or anytime after a spill or suspected contamination.
Annually.
Solid 180 days and room temp, preserved liquid 30 days and room temp, non preserved 14 and refrigerator, non aqueous is 90 days and room temp.
What compounds qualify for immediate use?
Shall open single use ampules be stored?
How often is air sampling performed?
Low risk. 1 hour cut off time.
Never.
Semi annually.
What ISO is buffer and ante air quality?
When do you not have to follow NIOSH containment procedures?
Do personal of reproductive capability need to confirm they understand the risks of handling HD?
Buffer is 7 and ante is 8
Not on list, If on list and you do an assessment of risk and list final dosage forms of compounds and drugs that do not require any further manipulation. Must have designated person to keep you in check.
YES. In writing. Must be reassessed every 12 months(just normally not for this repro thing.)
How do you take inventory?
When do prescribers need to check the CSD?
Either at opening or close, PIC and person taking inventory shall indicate the time it was taken and shall sign and date the inventory date and time sheet. Must document with signature within 3 working days.
When prescribing a C2 or C3 substance for the 1st time.
