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NC Pharmacy FAQ

Pharmacy Law Questions North Carolina

QuestionAnswer
May a pharmacy that services a nursing home install an automated dispensing device (e.g., Pyxis) to dispense controlled substances at the nursing home? Yes, provided the nursing home has a limited service permit. The pharmacy may apply for an additional DEA permit
Who can access the Photo ID records required of controlled substances (4/8 groups) 1-prescribers 2-state bureau of investigators 3-individuals for their own use 4-other authorities for a specific investigation
Who canNOT access the Photo ID records required of controlled substances (8 groups) local law enforcement or sheriff
last 4 groups Who can access the Photo ID records required of controlled substances (4/8 groups) 5-court order 6-division of medical assistance 7-licensing board for specific case 8-county medical examiner
how much time is allowed to process request for ID of a patient receiving II or narc-containing III's? Required to provide Identifying information within 72 hours to authorized individuals
Who receives electronic transmission of pseudoephedrine sales? NPLEx - National Precursor Log Exchange
Can NP's and PA's write for schedule III's? what quantity/refill limits? Both NP's and PA;s can write for schedule III's with refills up to the federal law. They cannot write for more than a 30 day supply.
Are pharmacists allowed to add DEA numbers if the doctor does not write it on a controlled substance prescription? Yes, they can add the DEA number without contacting the prescriber
If no generic is available, should the rx label contain the generic name? Yes, by law the generic name must be on every label.
What ingredients are required on the label of a compounded rx? All ingredients used in compounding should be on the label. Exceptions are made for standard items like Duke's Mouthwash.
Is tap water acceptable to reconstititute antibiotics? No, distilled or purified water should be used.
Are pre-filled saline/heparin flush syringes treated as prescription drugs or prescription devices? They are treated as prescription devices. They can be used as the result of a physician order, and only stored in a patient's home with proper labeling.
what are the continuing education requirements? 15 hours must be completed annually, and 8 of those hours must be LIVE. 5 hours are allowed to be carried over to the next renewal.
How long must CE certificates be saved? CE certificates must be saved at least 3 years. They can be stored at home or at work.
Can I use free clinic hours as live CE? Yes, 3 hours of free clinic is equal to 1 hour of live CE.
Can other continuing education count towards my pharmacist renewal? Yes, we accept Dental CE, Medical CE, Nursing CE and Veterinarian CE
What are the CE requirements for clinical pharmacist practitioners? 35 hours of CE per year. This includes the 15 h (8 Live) needed for regular pharmacists.
How many hours of immunization CE are needed to maintain immunization certification? 3 hours of immunization related CE every 2 years. can be live or correspondence.
What is the grace period for license renewal? 60 day grace period after deadline of December 31.
Are pharmacists who are licensed by exam required to have CE for their first renewal? No, this requirement for CE is waived.
If I am licensed, practicing, and residing in another state, may I meet that state’s continuing education requirements? yes, you may meet that state's requirements.
What changes can be made to CII's in NC after consulting directly with the prescriber? (6 things) date of issue-may be added, but not changed, patient's address, drug strength, dosage form, drug quantity-may not exceed original dosage prescribed, directions for use
When would the pharmacist require a new CII rx? if the name of the prescriber, patient, or drug name needs to be changed.
What 4 types of photo ID are acceptable for NC II's and certain III's? driver's license of any government, NC DMV ID card, passport of any government, or military ID. records must be onsite or at a central business location for 3 years.
Does the Photo ID requirement for II's and some III's include hospital patients? This requirement does not include patients in hospitals or other health care facilities. person receiving the rx must be an employee of the facility.
are electronic signatures valid for controlled substance rx's? No, at this time very few rx programs meet the DEA's certifiability req's.
What are req's for CII oral orders? must get the hard copy within 7 days. Only dispense amount required for emergency time period. DEA must be notified if prescriber fails to deliver written rx.
When can CII's be faxed? if compounded for direct parenteral administration; if patient is a LTCF resident; if patient is in hospice
Are partial fills allowed for CII? Yes, provided the remainder is supplied within 72 hours. exception is for terminally ill or LTCF patients: 60 days of partial fills allowed.
Are schedule V medications subject to the 5 refills / 6 months maximum? No, this requirement does not apply to CV's
When does a controlled inventory need to be taken if change of PM or ownership? must take a controlled inventory within 10 days.
How often is controlled inventory taken on a regular basis? Within 2 years of the last controlled inventory. exact II count; estimates of III-V when bottle is <=1000
How must the transfer of controlled substances be communicated? must be communicated between 2 licensed pharmacist
First 4 of 7 items required on a prescription transfer 1-original date of issue 2-original refills 3-date of original dispensing and last refill 4-number of authorized refills
second 3 of 7 items required on a transfer 5-number of valid refills remaining 6-Pharm name/add/dea/rx number 7-name of transferring pharmacist
is the patients address required to be handwritten on a CII-IV? No, the patients address need only be readily retrievable.
Can a controlled substance be available on a preprinted rx? No, it can be computer generated, but not preprinted.
3 valid reasons a pharmacist can refuse to fill an rx? it would be harmful to the patient, it would not be in the patient's interest, there is a question of its validity
When to make an offer to counsel? offer to counsel shall be made on all new and transfered rx's. documentation of refusal shall be kept on file for 3 years.
May a prescriber write for other rx's on a paper with a CII? Yes, CII RX's can contain other prescriptions.
what are requirements for reporting loss/theft? DEA must be notified within 1 business day and NCBOP must receive their own loss form within 10 days
can pharmacy interns transfer controlled substances? No, only the pharmacist can transfer controlled substances!
is a graphic of the prescriber's signature necessary for non-controlled rx's? A graphical representation of the prescriber's signature is sufficient to satisfy this rule. But it is not necessary. It is enough that the prescription contains an electronic signature "unique to the practitioner."
Do prescriptions in NC expire? No NC rule dictates when an rx expires. Only expiration date is from federal government for CIII and CIV = 6 months from the date of issue.
First 5 things that must be on an rx label 1-name and address of the pharmacy 2-serial number 3-date of the rx 4-name of the prescriber 5-name of the patient
second 5 things that must be on the label 6-name and strength of the drug 7-generic name, even if not available 8-directions for use 9-appropriate cautionary statements 10-first initial and last name!
last 3 things that must be on an rx label 11-if tranq or sedative, warning about alcohol 12-expiration date, either 1 year or the manuf. date 13-if in original container, do not obscure the exp date/lot number
weird privacy law for addiction treatment using suboxone or subutex when verifying a prescriber's waiver, it is a violation of federal law to disclose the patient's name, even if you are speaking directly with the prescriber
are stamped signatures valid for controlled substance rx's? No, stamped signatures are not valid
How can a prescriber get controlled substances (CIII&IV) from a pharmacy? Can only be transferred by use of an invoice. all prescriptions must be patient specific
Is there a 6 month 5 refill limit on schedule 5 controlled substances? No. CV's can be refilled as authorized.
what is the legend drug transfer limit imposed in NC? transferred drugs must not exceed 5% of the total 12 month prescription drug sales revenue of the transferor/ee. must be for an immediate medical need.
can you have more than one power of attorney? yes, provided the POA is signed by the receiver and whoever signed the last registration application.
what are the 3 classes of recalls? I-reasonable probability of serious injury or death II-medically reversible problems III-not likely to cause problems
Under what circumstance could a pharmacy take back non-controlled drugs for donation? Drugs must be given by a pharmacy permit holder to another permit holder
May a NP or PA dispense non-controlled drugs from a free clinic? Only if the drugs are labeled by a pharmacist with everything except the date and the patient's name.
do free clinic technicians register with the board? NO, but they must complete proper training.
Can I give prescription data to medical and dental board inspectors? Yes, if in the course of a legitimate investigation
When can you inform prescriber of patient's substance abuse history? Only if you are not working in a federally funded clinic focused on rehab
when can a pharmacist disclose protected health information? When the pharmacist reasonably suspects fraud has been committed. Also, when presented with a subpoena or court order
What are the first 4/11 drugs that are Narrow therapeutic index (NTI) drugs? carbamazepine, cyclosporine, digoxin, ethosuximide
what are the second 4/11 drugs that care NTI by NCBOP? Levothyroxine Na, Lithium, Phenytoin, Procainamide HCl,
What is considered an offer to counsel? first 2 of 4 Our pharmacist will talk to you about this if you like ... counseling is available from our pharmacist about this rx
What is considered an offer to counsel? second 2 of 4 our pharmacist is available to talk to you about your prescription... our pharmacist would like to talk to you about this medication
what can NP's and PA's prescribe? as allowed in their protocol, they can prescribe 30 day supplies of II-V's with refills as allowed by state law. must have own DEA#
What must be on a nurse practitioner's prescription pad? in addition to normal requirements, NP's must list the supervising physician and PA's must list supervisor MD's phone # also
How much time is allowed for a pharmacist to notiy the board of a new job location? must notify the board within 30 days
Is there a grace period for renewing CE? yes, 60 days from the deadline of December 31st is allowed.
What is the cutoff for daily dispensing in health departments? if more than 30 patients are serviced per day, then PM must check records within 24 hours
What about students enrolled in a technician training program? Do they count towards the 2:1 tech:RPh ratio? They would count toward the 2:1 ratio if the technician is employed by the pharmacy for more than educational purposes.
Are pharmacy students allowed to administer vaccines? Yes, provided they have the necessary training and they are supervised by a certified pharmacist vaccinator.
Must pharmacy students register as technicians with the board? No, only students enrolled to be technicians should register as technicians. pre-pharmacy students should also register
Can pharmacists dispense more than one refill at a time? Yes, provided it is not a controlled substance nor a psychotherapeutic.
If a physician retires, dies, or loses his license, may I fill a prescription written before the physician ceased practicing? Yes, provided a valid physician patient relationship existed. refills are still valid
Is an rx written for a specific number of refills valid for more than 1 year? Yes, provided the rx is not for a controlled med.
is there a 6 month/5 refill limit on CV's? No, can be refilled as necessary.
What is the rule on loaning a patient some medication until the physician's office can respond to a refill request? can dispense up to a 30 day supply of any drug except CII's. Must notify physician's office within 72 hours of what you have done.
Does North Carolina have a pharmacy of choice statute? Yes, any pharmacy may accept any insurance terms and bill for medications. A patient may choose to fill the rx at any pharmacy
What is required to use a pyxis or similar device in a LTCF? LTCF must have a limited service permit
When is a new pharmacy permit required? per .1603, when different entity gains >50% of the pharmacy; when a change in authority to designate leadership; change in location
What is the NC law on refill authorizations after a prescriber's death/loss of license/retirement? RPh is allowed to fill a one time emergency refill auth of up to a 90 day supply. no CII's!
Can a pharmacist fill rx's from foreign physicians? Yes, but they may not dispense controlled substances.
What is lthe law concerning emergency refills of medicines on the weekend? Except for CII's, pharmacists can dispense UP TO a 30 day supply of medication if it is necessary for the treatment of the patient. Must notify the prescriber within 72 hours of dispensing!
Must a drug be AB rated in order to perform drug substitution? No, AB rating is not mentioned in the NC drug sub laws. It is left to the pharmacist discretion.
Must all Medicaid rx's be written on tamper resistant pads? Yes, Excluding rx's for inpatient facilities
What drugs are taxable under NC state law? OTC drugs that are sold without an rx (insulin is an exception) and ingredients used to make rx compounds are taxable under state law (syringes and needles for insulin are taxable!)
What about selling OTC and legend drugs to physician offices? Legend drugs are not taxable, but OTC drugs require sales tax to be paid
what are the last 3 NTI drugs? (means the same manufacturer must be dispensed) Tacrolimus, Theophylline, and warfarin!
Created by: nickh88