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Pharmacy Law Qs

Pharmacy Law

How many hours of CE courses are required during a 2 year pharmacist license period? 30 hours
How long should a record of CE courses by kept for each pharmacist licensure period? 4 years
What happens if a pharmacist does not renew his/her license within 2 years? 3 years? 3 years after renewal date? Monetary fine if before 3 years; retake the Board Exam if after 3 years; license is canceled.
In what situations will a pharmacist license not be renewed? If there are outstanding payments on child support, alimony, or government issued loan for professional education.
Who do you notify if there is a change in PIC? Within what time frame? Board of Pharmacy; within 30 days
How many pharmacies may a PIC be in charge of? What is the distance requirement? 2 pharmacies; within 50 miles
If PIC resigns, how long can an interim PIC be placed? 120 days
Who do you notify if you have a change of address or name? Within what time frame? Board of Pharmacy; within 30 days
Is an intern allowed to have a key to the pharmacy? No
How many interns is the pharmacist allowed to supervise? technicians? clerks? 2 interns per pharamcist; 1 tehcnician per single pharmacist and 2 for every additional pharmacist; no limitations
How long can an intern license be extended if an individual has not completed the experience requirements for the licensure exams? 2 years
Is an intern allowed to perform special services, such as doing skin punctures? Yes but only if the supervising pharmacist has also been trained and is already participating in those services
The tech-check-tech program can be initiated in what setting? Acute hospital with an ongoing clinical pharmacy program. The drug orders must be originally approved by the pharmacist. PIC must carefully monitor policies and procedures.
Can clerks process refills from MDs? Yes, only if there are no changes to the prescription.
Who can receive new phone-in prescriptions? Pharmacists and interns
Can out of state prescriptions be filled? Yes, but only if called in (cannot be honored if Rx is written on regular Rx form)
What expiration date should be used on the label of a prescription? What if it is unit dosed? Compounded? Manufacturer's expiration date, or up to 1 year expiration date; 1 year expiration date unless manufacturer's date is less; beyond use date: product should not be used beyond 6mo
Are there refill limits on a Rx that has PRN refills? 1 year for non-scheduled drugs; no PRN refills for C-III, IV, and V (but can fill original Rx)
Can a Rx be written and filled for an "off-label" use? Yes, as long as the off-label use is supported by medical literature.
Misrepresentation of an Rx label may occur in which 2 situations? 1. If it is necessary for a clinical or investigational study through the FDA, 2. If it is appropriate treatment for the patient as determined by the prescriber
Can a for-profit pharmacy buy drugs from a non-profit pharmacy? No. However, a for-profit pharmacy may borrow from a non-profit pharmacy for the immediate need to fill a patient's prescription. The drug may be sold at its usual prescription price and the exact same drug must be returned to the non-profit pharmacy.
What are the requirements in order for a prescriber to dispense drugs? The drug must be dispensed directly to the patient, properly labelled, and with a written disclosure that the patient may obtain drugs either from prescriber or from a pharmacy of patient's choice. Samples must be dispensed at no charge, without a label.
What are the exceptions to using child-resistant containers? 1. Topical or non-oral products, 2. nitroglycerin tablets, 3. waived by pt (should document waiver and sign)
What is an "order of abatement"? Board inspectors cite pharmacy for something that needs to be corrected within a specific time. If it has not been corrected by the time the site is revisted by the Board Inspector, a regular citation will be issued.
Does a pharmacist have to report a lawsuit settlement in a pharmacy related matter? Report to the Board of Pharmacy if the settlement is >$3000.
Can a pharmacist refuse to fill a Rx based upon religions, moral, or ethical belief? Yes, as long as the employer is originally notified and the pharmacy makes reasonable accomodation to ensure that the patient gets the prescription in a timely manner.
Who is responsible to report employee theft or impairment problems? Within what time frame? PIC must report to the board of pharmacy within 30 days.
What is a medication error? How long before starting an investigation? Any variation (including delays) from a prescription or drug order not authorized by a prescriber, but does not include any variation that is corrected prior to furnishing the drug to the pt. Investigation shall commence no later than 2 business days.
How long should QA records be stored? QA records should be stored and immediately retrievable in the pahrmacy for 1 year from date the record was created.
What are the exceptions for providing patient consultations? If the prescription is a refill, or if the patient refuses consultation.
What are the 4 mandatory components of a patient consultation? 1. How to use medication, 2. the importance of complying with directions on the label, 3. how to store the medication, 4. advising on common severe ADRs or interactions
Can a pharmacist provide an emergency supply of drugs to a pt if there are no remaining refills? Non-scheduled drugs can be given in part or full amount even if the prescriber cannot be contacted; C-II, III, IV, or V may be dispensed in a reasonable quantity (72hrs worth) and the prescriber must be contacted when available (ASAP for C-II).
How long do patient medication profiles need to be kept? At least 1 year after last entry.
Are refill transfers between independent pharmacies allowed for non-scheduled drugs? C-III, IV, and V? C-II? Yes for non-scheduled; yes for C-III, IV, and V but may only transfer one time (unless within same chain) and must record DEA number of both pharmacies; yes for C-II but DEA Form 222 required.
What is the pharmacy self assessment survey? Who must complete this? When? How long should the survey be kept as record? Survey whose purpose is to promote compliance with applicable laws; PIC; due July 1st every 2 years (odd-numbered years); 3 years
How long must a community pharmacy prescription be kept? Clinic pharmacy prescription? Patient medication profile? QA report? HIPAA notice? Controlled substance inventory record? DEA form 222? Self-assessment record? Medication error report? Comm 3 years; Clinic 3 years; Pt 1 year; QA 1 year; HIPAA 6 yrs; Controlled 3 years; DEA 2 years; Self 3 years; Error 1 year
How long before informing the BOP for change of address and name? PIC change? Reporting drug loss? Bankruptcy? Change in pharmacy permit? name 30d; PIC 30d; drug loss 30d (immediately for DEA if scheduled); bankruptcy immediately; permit 30d
Which drugs require mandatory patient package inserts? All estrogenic drugs, accutane, and the Medrol dosepack.
How frequently is the permit to operate a pharmacy issued? If a pharmacy is transferring ownership, how long does a temporary permit last? Yearly, up to 180 days.
Who may sign for ordered drugs from a wholesaler when they arrive at the pharmacy? Pharmacist or intern (not tech or clerk).
Which 3 auxiliary prescription labels are required by law? Whether the drug causes drowsiness, vision changes, or if it cannot be taken with alcohol.
Do you have to be a pharmacist to own a pharmacy? No, but if licensed prescribers, may only own up to 10% of shares either individually or collectively (unless physician groups owning hospitals with pharmacies within)
Can a clinic dispense C-II drugs? No, only C-III, IV, and V. If prescriber is licensed to prescribe controlled substances, they may write for C-IIs and have it filled at an outside pharmacy.
What are 4 requirements in order for a pharmacy to be able to store records off-site? 1. Waiver must be granted by Board, 2. pharmacy must be able to produce requested records within 48hrs or 2 business days, 3. secure storage facility, 4. confidentiality of records must be maintained.
How long does a non-scheduled prescription drug record need to be stored? Scheduled drug records? 1 year for non-scheduled and 2 years for scheduled drugs, from last date dispensing from this class of prescription
Can a non-resident wholesaler provide drugs and devices to California? Yes, but they must be registered with California.
Can a pharmacist substitute a brand for generic without notifying the MD? Yes, as long as it is for the benefit of the patient. Patient must be notified of switch and informed of savings. No substitution if prescriber indicates "do not substitute".
If registered with a Disease Prevention Demonstration Project, how many hypodermic needles can be dispensed without a prescription, without recording the sale, and without requiring ID? 10; ID only required if requesting party appears <18yo.
May sample prescription drugs be stored and dispensed from a pharmacy? No. Exception - if there is an emergency medical reason where regular supplies are unavailable, if the prescriber transfers sample drug to pharmacy, if it is provided at no cost to patients, and if the prescriber places this intent in writing.
What are the requirements in order to dispense veterinary drugs? BOP permit issued to retailer. Exemptee (non-pharmacist) may sell items if they have completed a training course and if controlled substances are countersigned by prescribing vet. Rx may not be refilled after 6mo.
Can a pharmacist dispense replacement contact lenses? Yes if the pharmacist is registered with the Medical Board of California. Expiration date NTE 1 yr from date of last prescribing exam.
Pseudoephedrine restrictions? What information must the logbooks contain? Max 3.6gm/day and 9gm/month. Logbook must contain patient's name, address, date, time of sale, and signature. No need to log if single 30mg or 60mg tablet purchases.
What strength of iodine solution can be sold OTC? Iodine tinctures? 1% solution and must be less than 8oz; 2% tincture and must be less than 1oz.
Can prescription drugs that are returned by a patient to the pharmacy be resold by the pharmacy? Once a Rx is filled and dispensed to a pt and the pt has it in his/her possession, regardless of the time they have held on to it and regardless if it is still in an original drug package, the drug cannot be reused and re-dispensed to another pt.
How is compounding defined? 1. Altering dosage form/system, 2. altering strength, 3. combining components or active ingredients, 4. preparing product from bulk substances
Are pharmacists allowed to advertise compounding for specific products? Yes, FDA Modernization Act (FDAMA) in 1997 that originally prohibited this was recognized as unconstitutional.
How frequently do compounding areas and laminar air flow hoods be certified? How long do the records need to be maintained? Annually; records need to be kept for 3 years.
What state agency has jurisdiction over scheduled drugs? State Department of Justice (DEA or drug enforcement agency is under this dept)
Which drugs are C-II in CA but not federally? Secobarbital tabs, caps, liq, and inj, but not suppositories (fed C-III), apomorphine (fed not scheduled), pure paregoric (fed C-III) but becomes C-V if mixed with non-schedule drug (millk of bismuth)
What does CURES stand for? Controlled Substances Utilization Review & Evaluation System
Which drugs are required to be transmitted to the CURES database weekly after filled? C-II, III, and IV
What two items are required to be in writing for C-II presscriptions? Signature and date of prescriber; if omitted, Rx must be returned to prescriber for correction
In what situation can a C-II prescription be written on a regular Rx? If it is for a terminally ill pt and "11159.2 Exemption" is written or typed on it. If exemption is not included, pharmacist may still dispense but prescriber must correct within 72 hours.
How long can a security prescription for a C-II drug be held before filling? 6 months
Can a C-II prescription be corrected? Yes, if the prescriber is called to discuss the error or omission and if the correction is noted on Rx
What are 3 ways to order a C-II? 1. Secure form, 2. phoned or faxed if it is for an emergency need, or if ordered by SNF, intermediate care facility, or home health agency providing hospice care 3. regular paper Rx for terminally ill
If a C-II prescription is faxed or phoned for an emergency, how long until the prescriber must forward the security form? How long to report if delinquent? 7 days; pharmacy must report in writing within 6 days to DEA if delinquent
Can an electronic order for a C-II be received from special facilities (i.e. SNFs)? Yes, the pharmacist must write order on special security prescription prepared for the pharmacy
What must be done if a C-II drug cannot be filled in the quanitity specified? Remaining portion must be filled within 72hrs, or else a new security Rx must be written for remainder by the prescriber
What must be done if the patient requests less the full amount for a C-II drug? Prescriber must be contacted for approval. Remaining amount cannot be filled at a later date because this would constitute a refill that is not allowed for C-IIs.
What is the DEA Form 222 used for? DEA Form 222 is a triplicate form used for ordering or transferring C-II drugs. Employee does not have to be a pharmacist but must be registered with the DEA. Top copy to supplier, middle is sent by supplier to DEA, bottom copy retained by pharmacy.
Which drug is recently classified as C-V? Pregablin (Lyrica) for peripheral neuropathy and postherpetic neralgia.
Do C-III, IV, and V drugs need to be on special security forms, like C-IIs? What can you do if it isn't? Yes; The pharmacist must contact the prescriber to orally verify and record the infromation on the pharmacy's own prescription forms.
Are phone-in orders or electronic transmissions allowed for C-IIs? C-III, IV and V? Yes but only in special circumstances; Yes
What are the refill allowances for C-III, IV, and V? May be refilled 5 times within a 6 month period. Total refill amount NTE 120 days supply of actively taking the drug without contacting the prescriber and generating a new prescription.
If there are no refills remaining on C-III, IV, or V, may an emergency supply be given if prescriber is unavailable to OK? A reasonable quantity (72hr supply) may be provided. Prescriber must be informed ASAP and action must be noted on reverse side of Rx.
Can an out-of-state prescription for controlled substances be filled and refilled in CA? Not for C-II (unless it is filled in CA for delivery to state where prescriber is from); Yes for C-III, IV, and V (must be on special security forms or phoned in).
How do you verify the authenticity of a prescriber's Federal Controlled Substance Registration Number (AL 8010869)? Sum of #s in odd sequence x/c last number +(2 x Sum of #s in even sequence) = last digit (i.e. 8+1+8 + 2x(0+0+6) = 17 + 12 = 29)
How frequently are you required to take an inventory of your scheduled drugs? How long is the inventory to be maintained? Every 2 years; maintain records for 3 years.
What are federally required auxiliary warnings for controlled substances? If the drug causes drowsiness, and the label "drug is not to be provided to any other person other than the person it was prescribed for".
What is the DEA Form 41? DEA Form 41 is a triplicate form used to itemize scheduled drug items intended for disposal.
May a pharmacist dispense scheduled drugs (i.e. methadone) to a patient for an addiction problem? No, unless the pharmacists and pharmacy are part of the Authorized Addiction Treatment Program - (allowances made to inpatients if prescriber feels it is necessary).
May a pharmacist dispense specific drugs to treat addiction if not part of a state government program? Suboxone (C-III) and Subutex (C-III) may be dispensed if the prescriber has >8hrs of training and has acquired a 2nd DEA number with "X" in front.
What is the minimum area for operating a community pharmacy? A reasonable area sufficient to accommodate for the safe and efficient performance of pharmacy-related activities.
After a pharmacy license has been voided or when the pharmacy owner notifies the state board of the intent to remain closed, within how many days must all drugs be arranged for transfer to another licensee? Within 10 days.
An optometrist who has a TPA-certification ("T" at end of license number) may write for which prescription drugs? 3-day supply of hydrocodone or codeine with a non-scheduled drug, topical anti-inflammatory drugs, topical anti-glaucoma drugs, oral antibiotics, and topical/PO antivirals.
Within what time frame must the remaining portion of a C-II prescription be filled for a terminally ill patient? Within 60 days from when the prescription was written.
What are labeling requirements for sterile injectable products? Telephone number of the pharmacy, name and concentration of ingredients, storage and handling instructions, and the label "chemotherapy-dispose of properly" if it is a cytotoxic agent
What are labeling requirements for a prescription? name and address of pharamcy, prescription number, name of patient, name of prescriber, date of issue, name of drug, strength of drug, qty dispensed, exp date, indication, physical description of drug
Created by: c0c0nut87