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NC Pharmacy Laws

North Carolina Pharmacy Practice Act

QuestionAnswer
Describe dispensing prep/packaging an rx drug/device and labeling the container with information required by state and federal law. filling or refilling drug containers is dispensing, so is providing quantities of unit dose prescription drugs
Define the practice of pharmacy 1-interpreting and evaluating drug orders, 2-dispensing and labeling rx drugs and devices, 3-safely storying drugs and devices, 4-maintaining proper records, 5-controlling pharmacy goods/services
who is responsible for enforcing the practice act? the NCBOP is responsible for enforcing the laws of the practice act
What is the makeup of the board? 6 members, each serving 5 year terms, one shall be a public member not a health care provider or married to one. max of 2 consecutive 5 year terms. must reside in north carolina in order to vote.
When must new techs register with the board? must register within 30 days of finishing training program
What are requirement to hire a tech from a PM standpoint (3 things) 1-must be enrolled/have HS diploma 2-PM notifies board w/in 30 days of date of hire 3-PM provides training program (completed within 180 days of hire; only required 1x)
What is the RPh:tech ratio? any more than 2:1 tech:RPh requires approval from the board. addt'l techs must be PTCB cert.
When do licenses expire? Annually on 12/31. can renew beginning 12/1. 60 day grace period 1/1-3/1.
How many days allowed before change of address/employment required? 30 days to report change of address or employment
Timeframe when board requires appearance and submitting of evidence that RPh can practice pharmacy? Greater than or equal to 5 years of non-renewal
Time in which PM must notify the board about changes in personnel? 30 days notice of personnel changes
Are out of state pharmacies required to register with the board? Yes, annual reg req'd. must be current in the state where they reside
What is requirement of out of state pharmacist? agree in writing on a form approved by the board to be subject to the jurisdiction of the board
What must be conspicuously posted in a pharmacy? PM license, Pharm permit, current renewals.
What must be readily available in a pharmacy? license / last renewal of staff pharmacist
How can a provider ensure no substitution permitted? sign DAW line, write DAW, or verbally state no substitution
what are the requirements for NTI drugs? refilled using only the same drug product by the same manufacturer that was last dispensed. even new rx's which continue therapy. PT/Presc must both allow override
When do rx's expire? legend refills do not expire, rx's marked prn expire after 1 year
What are rules about nurses dispensing in public health clinics? Nurses can dispense legend (not controlled drugs) from an approved formulary; dept must register with BOP; PM/other shall review dispensing records weekly
Can a person who presents legal written request of rx records receive them w/o being the patient? Yes, so can prescribers/RPh's who are treating the pt, even if not same prescriber.
What is the board's disciplinary authority? issue a letter of reprimand, suspend/revoke/refuse renewal of a license, may require remedial education, apply for an injunction
are free clinics allowed to resell drugs? No, only allowed to charge a handling fee not to exceed medicaid price.
How many months must donated drugs be unexpired in order to donate? Must be unexpired for 6 months minimum
Are quality assurance programs required for community pharmacy? Yes, a process must exist for the continuous reduction in medication errors.
How are med errors reported to the board in the case of a complaint? within 10 days of notice of the complaint, the pharmacy shall compile list of med errors for the previous 12 months within 10 days
Auditing rights (4) 14 days notice of an on-site audit; clerical errors are not fraud; no more than 1 audit per calendar year, unless misrepresentation is suspected; no extrapolation
PA prescribing limits and rx req's (4) 1-licensed in NC 2-NCMB # on written rx's 3-written policy with a physician 4-compounding/dispensing must occur under supervision of RPh
Nurse practitioner prescribing limits (3) Similar to PA; 1-NCMB gave ID # which appears on rx's 2-written agreement with a physician 3-dispense/compound under supervision of a pharmacist
Clinical pharmacist prescribing limits CPP implement predetermined drug therapy; NCMB given ID# to appear on rx's;
difference between a CS and CS analogue CS includes immediate precursors; CS analog means a look alike drug; schedule I CS analogues shall be treated like C-I drug
Name 2 CIV's and 2 CV's CIV's-Eszopiclone (Lunesta) and Zaleplon (Sonata) CV's-Pregabalin (lyrica) and diphenoxylate with atropine (lomotil)
Name 2 schedule 6 drugs marijuana and THC
Can schedule 5 drugs be dispensed without an rx? Yes, page 36 of practice act, person must be 18y/o with reasonable medical use. Remember the 5 refill/6 month limit does not apply to CV's
Whose ID must be presented in order to dispense a CII rx? The ID of the person picking up the rx must be present. does not apply to inpatient rx's or rx's given to employees of a hospice company
What ID's are allowed for II's and select III's (narc)? drivers license, NC ISSUED state ID, Military ID card, Passport
What are the reporting requirements for II's and select III's? must report pickups within 72 hours and keep a record of pickups for 3 years
Which officials are allowed to inspect rx records? page 37, auth'ed federal and state inspectors. employees of the NCDOHHS.
pseudoephedrine limits for NC? only be sold in blister packs, to a patient >=18 y/o, stored and sold behind the pharmacy counter
What are the record keeping requirements for NC pseudoephedrine? maintain a record for 2 years and must be available w/in 48 hours. new law requires electronic submit to National Precursor Log Exchange (NPLEx) as part of a sale
PSE package limits /day /month? 3.6 g or 2 total packages per day. 9g or 3 total packages per 30 days.
PSE limits do not apply to... liquids, gels, or pediatric products. prescription PSE.
can an individual access his own controlled substance record? Yes, if he requests so. Others: SBI, Pharmacists, Prescribers, licensing boards.
What are the Health Care ID laws in NC? When providing health care, ID including individual's name and license/certification held. abbreviations are acceptable. not required if prov. can be readily ID'ed by being in the provider's office.
if a hospital pharmacy is not open 24/7, what are the requirements for dispensing? (4) 1-dispense NMT 24h supply from a formulary 2-prepackaged by the pharmacy 3-MD/PA/NP must initial the label and sign the dispense book 4-pharmacist verifies book weekly
Can a II-V have a preprinted rx pad? Nope, preprinting rx pads of II-V is prohibited
What are the dispensing limitations for dronabinol and nabilone? Must only be dispensed for antiemetics in cancer chemo.
what warning label must appear on tranq/sedative meds? the consumption of alcoholic beverages may be harmful to your health
How are rx insurance cards regulated by the BOP? states each plan shall issue a uniform rx card. must contain address and phone number. new card required within 12 months of a change in the coverage. must contain electronic verification like barcode or magnetic strip.
When must an early refill be covered by an rx plan? page 55, when a declared state of emergency exists in the county where the insured resides. must request refill within 29 days of declaration
What about health benefit plans excluding a pharmacy? "any willing provider" states that terms of benefit plan may not favor one pharmacy over another or require mail order services. 60 days notice must be given to pharmacies when a new plan is added
Created by: nickh88