Oregon MPJE

Is a pharmacist’s signature required on hardcopies or will initials suffice?
It is acceptable to either sign, initial, or utilize an electronic record identifying the verifying pharmacist.
Can a pharmacist change the date-to-fill after talking to the prescribing doctor on a CII?
The date-to-fill is part of the directions written on the script therefore it would be allowed to change after speaking with the prescribing doctor.
How are outdated CIIs destroyed?
See 21 CFR 1307.21and OAR 855-080-0105 (reverse distributor, DEA, Board approved Plan).
Can physician assistants and naturopaths prescribe CII medications?
Yes, check the formulary at http://www.oregon.gov/OBNE/rules/850-060-0226.pdf. PAs may if they hold a current DEA registration for CII medication.
Does a pharmacist need to cancel a CII prescription across its face and sign?
No
What is the law for selling a controlled substance for office use? CII? CIII-V?
A prescription cannot be written to provide medical offices medications. If the office wants CII medications a DEA 222 form must be used to transfer the CII stock. For all other medications, an invoice must be utilized.
Does post-dating the prescription for a CII by the prescriber void the prescription?
The prescription must have the date it was written on the hard copy. For more information call the DEA office at 503-721-6660.
Is a typed CII prescription with an electronically signed signature a valid prescription?
No. The prescription needs to be hand signed by the prescriber.
Is a CII perpetual inventory required in all practice settings?
No, it has been required in hospitals for a long time (monthly reconciliation). A quarterly reconciliation is required for retail pharmacies but not a perpetual inventory.
Does the CII annual inventory have to be separated from the CIII-V inventory?
Yes, they can be on the same report as long as listed out separately.
How long do we need to keep CII inventory records?
3 years.
What is required of drug outlets electronically ordering CIIs?
The pharmacist must be able to retrieve the electronic DEA 222 from their ordering system for review by Board inspectors. This electronic form must contain the date and quantity of each controlled substance received.
In which cases are partial fills on CII prescriptions allowed?
Partial fills are allowed on CII prescriptions when: 1)The pharmacist is unable to fill the entire amount and the remaining balance is dispensed within 72 hours. If the remainder is not filled within that timeframe, then the remainder is lost and the prescriber should be notified of the actual quantity filled. 2)For patients that are residing in a long term care facility or community based care facility or diagnosed with a terminal illness in which scripts are good for 60 days from the date the prescription was written.
What information must be documented on the original hardcopy or electronic record (a single screen) each time you partial fill a CII for hospice/terminally ill patients, long term care or community based care patients?
The date dispensed, quantity dispensed each time, amount remaining after each fill and pharmacist who dispensed it.
Can a CII prescription be changed from a capsule to a tablet or liquid form of the same medication?
Yes, if you contact the prescriber and they authorize the change. If the prescriber is not reasonably available for consultation and the prescribed drug does not utilize a unique delivery system technoloy, an oral tablet, capsule or liquid form of the prescribed drug so long as the form dispensed or administered has the same strength, dose and dose schedule, and is therapuetically equivalent to the drug prescribed. Per
If a CII medication is written with only the first or last name of patient, can a pharmacist call the prescriber to clarify it and then fill the prescription?
Yes.
What changes can a pharmacist make to a CII prescription after speaking to the prescriber over the phone?
A pharmacist CAN change the drug strength, dosage form, drug quantity, and the directions. Changes that cannot be made are the patient’s name, controlled substance prescribed, and the addition of a prescriber’s signature (the prescription must be hand signed).
In which situations can a faxed CII prescription serve as an original prescription?
A faxed prescription can serve as an original for patients in a long term care facility , community based care, enrolled in hospice, or receiving home infusion/IV pain management therapy. The prescription must be manually signed by the prescriber prior to faxing.
Is it legal to write/fill a CII prescription on the same page as a second prescription?
Yes, but the prescriptions must be correctly filed and cross-referenced. The original must be filed under the highest controlled prescription.
If a prescriber writes for a quantity of a CII that is greater than the amount the patient’s insurance will pay for, can the prescription be split into two prescriptions, one for insurance and one for cash?
Yes. Both prescriptions must be filled and dispensed/sold at the same time.
Can a prescriber write multiple prescriptions for a CII on the same day to be filled on different dates?
Yes, as long as the total quantity does not exceed a 90 day supply and each subsequent prescription states the earliest date it can be filled and the practitioner provides written instructions on each written prescription. [CFR 1306.12(b((ii)]
Can prescribers post date CII prescriptions?
No, the prescription must have the date that the prescription is actually written and a fill date can be designated in the instructions to the pharmacist.
Does a limit exist on the quantity of CII medication that can be dispensed from a single prescription?
No, but use professional judgment.
Is it ok to fill a CII from a state that is not contiguous?
Yes, but use professional judgement and make certain the prescription is valid. ORS 689.525(1)(2)
For drug recalls on a CII, can good drug be exchanged for the recalled drug?
Yes, it can be exchanged without a new prescription, but you need to document on the hardcopy what was taken back and the quantity replaced.
If there is a shortage of a CII such as oxycodone, can the RPh change the drug to oxycodone/APAP after consulting the practitioner?
Yes.
Can a CII be transferred between pharmacies with interactive databases (i.e.. Walgreen’s)?
Under no circumstance can a CII be transferred.
Do you have to file CIII-V invoices separate from CII invoices?
Yes.
Is it ok if CIII-V prescriptions are filed with regular legend drugs even if there is no identifier to manually separate them?
Yes, as long as the store can run a report of all CIII-Vs dispensed that is separate from the regular legend drugs.
How many refills are allowed by law on schedule III-V medications?
A prescription written for a schedule III-V medication is good for 6 months or 5 refills whichever comes first.
Can a prescriber’s agent call in or verbally verify a CIII-V prescription?
Yes, they can verbally verify it for the pharmacist or intern.
Can a pharmacy fill an e-script for a scheduled III-V medication?
Yes, If in compliance with CFR 1306.08.
What schedule are pseudoephedrine, phenylpropanolamine and ephedrine in Oregon? When did they become scheduled?
Schedule III as of July 1, 2006.
Does a partial fill on a CIII-V medication constitute a refill?
Partial fills are allowed on CIII-V medications and do not constitute a refill. The partial dispensing may not exceed the total amount authorized in the prescription order (i.e. Vicodin #90 dispensed as #30 filled 3 times constitutes 1 refill).
Can a prescriber’s agent sign a refill request or prescription for a CIII-V medication?
No.
Does the 6 month limit for refills on schedule III-V medication mean a 6 month quantity limit?
No, the prescription is valid for 6 months from the date it is written and can have up to 5 refills. After 6 months the script is no longer valid and any unused refills are void. The rules do not apply to quantity dispensed. (It is legal to dispense a prescribed quantity that exceeds a 6 month supply).
Is there a limit on how much pseudoephedrine or phenylpropanolamine a pharmacist can dispense?
No, it is dictated by whatever the prescriber writes for within the DEA limitations for a CIII (i.e. 6 months or 5 refills).
Can a pharmacist ever dispense a year supply of a CIII-V?
Yes, it depends on how the prescriber wrote the prescription (i.e. if the prescriber wrote for “#365 1 tab daily”, the pharmacy could fill the whole prescription at one time for the full quantity). Use professional judgment and fill in context.
Can a technician take a phoned in refill okay for a drug classified as a CIII, CIV or CV that has no changes of any kind?
No.
Can CIII-Vs be transferred in between the same chain store via the computer system more than 1 time?
Only if they share a real time database where each fill at each location can be seen in real time. This is not considered to be a transferred prescription.
Does the pharmacist need to notify the prescriber if a sig is changed due to a substitution of medication strength? (i.e. Zoloft 100mg 1/2 tab daily vs. Zoloft 50mg 1 tab daily)
Yes, the prescriber should be alerted of the changes to ensure that the information in the patient’s chart is correct.
Can a charitable pharmacy accept controlled substances and/or OTC drugs for donation?
No
Who can bring in drugs for donation?
Anyone, but donated drug must meet the criteria laid out in the rules and the pharmacist may always use their discretion as to whether or not the drug is safe and appropriate for re-dispensing.
Is there an expiration date guideline for donated drugs?
Yes, a charitable pharmacy may not distribute a donated drug that bears an expiration date that is less than nine months from the date it was donated
What patients qualify to receive charitable drugs?
A patient who has a valid prescription for the drug, is a resident of Oregon and is underinsured or does not have adequate health insurance for the prescription requested or a patient enrolled in a program of public assistance as defined in ORS 411.010
Will prescription drugs that were dispensed in a standard prescription vial, to an individual patient who manages their own medications, be accepted for re-dispensing?
No.
What is a shared service contract?
A contract that allows an Oregon pharmacy to compound for another Oregon pharmacy or prescriber without being licensed as a manufacturer. The pharmacy or prescriber can dispense the compound to their patients or use it for office use. The Oregon pharmacy must only do a limited amount of compounding sales to have this kind of contract.
When a compounding pharmacy performs a quarterly audit of all bulk CII powders, does the powder need to be weighed out each time?
It would be acceptable if the pharmacy initially weighs the active powder and the empty container and then tracks the descending weight of the container for each quarterly audit.
Can pharmacies compound products for OTC sale under a retail license?
No.
Are pharmacists required to counsel on prescriptions that have been reassigned if there are no changes on them?
No, but the pharmacist may use their discretion.
Do DURs have to have a hard halt that requires a pharmacist override to proceed?
No, this is preferable, but a system that documents which pharmacist performs each function (i.e. DUR vs. verification) and ensures DURs are performed is acceptable.
Does the pharmacist need to perform a DUR on refills?
Yes.
When can an emergency medication supply be given and what quantity can be given?
Up to a 72 hour emergency supply can be given on non-controlled medications that the patient is currently taking, when no refills remain and while awaiting the prescriber’s authorization.
What expiration date should be listed on the prescription label?
The pharmacist should use their professional judgment. Although 12 months is often the standard of practice, the manufacturer’s expiration date or a date less than a year may be used if appropriate.
How do pharmacies sell prescriptions purchased by the prescriber “for office use?”
Prescriptions “for office use” must be sold on invoice. A file should be kept of all invoices separate from wholesaler invoices. CIIs must be transferred by a DEA 222 form initiated by the purchasing practitioner. Prescriptions are patient specific, sales to prescribers must be sold on an invoice and not be processed as a prescription.
What regulations exist for mailing prescriptions out of state?
Check with each state that the pharmacy will be mailing to.
Can pharmacists fill prescriptions for prescribers from other states, US territories and US military bases?
Yes, if they are licensed in their own state, practicing within their scope and have a valid patient/prescriber relationship.
Who does the pharmacist contact if they feel a prescriber is overprescribing a controlled substance, unsafely prescribing or unethically prescribing?
The prescriber’s regulatory board (i.e. Board of Nursing, Oregon Medical Board).
Can a prescriber or group of prescribers have ownership positions in a retail pharmacy?
Yes, but they may not have possession of the pharmacy keys.
Does a drug have to be AB rated for generic substitution in Oregon?
No, it is up to the pharmacist to use their professional judgment. See ORS 689.515 (2).
Can a fee be charged to a Medication Assistance Programs (MAPs) patient?
Yes.
Can a pharmacist fill a prescription based solely on an internet questionnaire?
No, the prescriber and patient must have a valid patient/prescriber relationship which usually includes a physical exam. See 855-019-0210(2).
Can a pharmacist supervise 2 interns at the same time in a Traditional Pharmacy-practice Internship ?
No, in a Traditional Pharmacy-practice Internship the ratio is one intern to each pharmacist or pharmacist preceptor regardless if one of the interns is a school based placement. A traditional internship is characterized by an intern working outside a school based program and is volunteering or being compensated for their time. A School-Based Internship is characterized by not recieving compensation but recieving credit towards a degree.
If only the final verification of prescriptions are being done in Oregon, does the central fill pharmacy have to be licensed in Oregon?
Yes.
Do out of state pharmacists and technicians have to be licensed in Oregon if they are working for a mail order pharmacy that sends prescriptions to Oregon patients?
No, but the PIC must be licensed in Oregon.
Which out-of-state central fill employees must be licensed in Oregon?
Pharmacists and technicians that participate in any function of the dispensing process for Oregon patients must be licensed in Oregon.
Do out of state pharmacies have to be licensed in Oregon if they fill prescriptions for Oregon patients?
Yes.
Where can a pharmacist find information about the Death with Dignity Act?
http://public.health.oregon.gov/ProviderPartnerResources/EvaluationResearch/DeathwithDignityAct/Pages/index.aspx
Can pharmacy records be stored off-site?
Records must be stored onsite for at least one year and may be stored in a secured off-site location if retrievable within three business days for at least 2 more years for a total of 3 years. Records and documentation may be written, electronic or a combination of the two.
Can a pharmacist refuse to fill a prescription?
Yes, but pharmacists should use professional judgment including awareness of the position papers that the Board has regarding moral and ethical objections and pain management. The pharmacist cannot be a barrier to access.
Do dental hygienists have prescribing authority?
Yes, but it is very limited. Under the supervision of a dentist they may prescribe fluoride, fluoride + varnish, antimicrobial rinses. Also, they may prescribe NSAIDS if they have received further training.
Can a pharmacist fill a hand delivered prescription that has an electronic signature on it?
No, hand delivered prescriptions must be manually signed by the prescriber or their agent.
Is it ok for a prescriber’s agent to sign a prescription for them?
It is okay for them to sign the prescriber’s name followed by their name or initials on faxed non-controlled medications only.
How can a pharmacist verify that a prescriber is allowed to prescribe Suboxone® or Subutex® for opioid addiction?
Pharmacists receiving a prescription for Suboxone® or another approved narcotic to treat opioid addiction should verify that the prescriber has been granted a waiver. The following can be used to verify that the prescriber is approved to prescribe Suboxone® or Subutex® for opioid addiction:1) Check the prescriber’s Drug Enforcement Administration (DEA) number; physicians granted a waiver under DATA 2000 are issued a special DEA number that always begins with “X”; as of July 2005, physicians are required to include this special DEA number on all prescriptions for Suboxone® or Subutex®;2) Check the Substance Abuse and Mental Health Services Administration (SAMHSA) physician locator at: http://www.samhsa.gov/;3) Call SAMHSA at 1-866/287-2728 (physicians can elect not to be listed on the Web site); or4) Call the prescriber and ask to have the DEA registration certificate faxed to you.
Does a prescriber need the Substance Abuse and Mental Health Services Administration (SAMHSA) waiver if they are using Suboxone® to treat pain?
No.
Does Oregon law limit the initial quantity of drug dispensed for a prescription medication?
No.
Can a pharmacist combine refills on a prescription to give a greater dispensed quantity?
No, unless the pharmacist has received prescriber authorization to do so.
Does the refill authorization fax have to be kept as the hardcopy when adding refills?
Yes, unless the computer system can add refills to the unchanged prescription and the system does not create a new prescription number (documentation of authorizing agent and authorization source must still be retrievable in this situation).
What info has to be on a refill authorization?
Date, number of refills authorized, and name of authorizing agent.
Can a pharmacy take back prescriptions after they are dispensed to the patient?
If an error is made on a scheduled medication or if it is a nonscheduled medication, the pharmacy may take it back for destruction only.
Does a technician in another state doing work on behalf of an Oregon pharmacy have to be licensed in Oregon?
Yes.
Can techs take new prescriptions off of voicemail to later be verified by a pharmacist?
No.
Can a clerk take an oral authorization from a prescriber or a prescriber’s agent for a refill?
No.
Can clerks pull drugs off of a pharmacy shelf to be used in filling a prescription?
No.
Can a technician take changes on either a prescription or refill request?
No.
When is a technician or clerk allowed to inform the patient of a change in manufacturer?
A technician or clerk may inform the patient of a change in manufacturer on a prescription, that doesn’t otherwise require counseling from the pharmacist, if the following criteria are met: 1) the pharmacy must have a policy and procedure in place, the technicians and clerks must be trained properly and the training must be documented, 2) the technician or clerk must inform the patient that the pharmacist has changed the manufacturer and that the medication may look different, 3) the technician or clerk must point out the product identification label (PIL) and tell the patient that the PIL should match the contents of the prescription container, and 4) the technician or clerk must then offer the patient an opportunity to speak with the pharmacist.
When can a prescription be transferred in or out of the country?
When they are coming from or going to a US military base or US territory.
If a prescription is inadvertently faxed to the wrong pharmacy, can that pharmacy fax it to the correct pharmacy?
Yes.
Do I need to follow the rules set forth in division 45 if I do simple compounding (like magic mouthwash or mixing 2 creams) in my retail pharmacy?
No. Simple and infrequent compounding using non-sterile commercial components to fill a single prescription for a non-sterile product is classified as Category 1 compounding. The Board states that Category 1 compounding is not considered compounding for all intensive purposes.
When does category 1 compounding become category 2?
When the compounding becomes complex (multiple ingredients, etc…), requires complex calculations, a scale is needed to weigh ingredients, if it requires alterations of the original dosing form (making capsules, etc…), or changes in the route of administration (making suppositories, etc…). Any of these requirements would result in a compound that is no longer classified as category 1.
Can you make a compound without a prescription?
You may compound a reasonable amount of drug product without a prescription, but you must be anticipating prescriptions for what you are compounding or you must be distributing the product under the Shared Pharmacy Services agreement (as defined in OAR 855-006-0005).
Does division 45 apply to nuclear pharmacies?
No. Radiopharmaceuticals have their own guidelines and are exempt from division 45. For information on nuclear pharmacies see division 19 and 42.
If compounding a non-sterile product, do I need to comply with division 45?
Yes. Division 45 applies to sterile and non-sterile compounding, unless the compound is classified as category 1.
Does division 45 incorporate USP chapters 797 and 795 rules?
No. The Board doesn’t require strict application or adherence to all USP 795/797 guide-lines. It is expected that appropriate guidelines be followed based on individual settings.
What are the training requirements for compounding in division 45?
The PIC is responsible for training, testing, and assessing all employees involved in sterile and non-sterile compounding. The PIC must also implement policies and procedures for employees to follow that are reviewed at least annually. This includes a verification procedure for pharmacists to determine correct drug, dose, form, calculations, and label. For low to medium risk compounding retesting aseptic skills must occur at least annually and retesting for high risk compounding must occur at least semi-annually. Records must be kept to demonstrate training and testing.
Are we allowed to compound anything the doctor prescribes?
No. You may not compound products that are commercially available, unless the Board has given prior approval to compound a commercially available product that is temporarily in short supply/unavailable. For parenteral products a commercially available product may be compounded if there are multiple companies that provide the mixture (ex. KCl premixed IV bags) or if the premix IV admixture is commercially available as well as the premixed IV bags (ex. Using a commercially available vial of medication to make an IV bag, even though there is a commercially available premixed IV bag).
Are there specific policies and procedures for the compounding pharmacy?
If a pharmacy participates in compounding, the PIC must ensure that there are policies and procedures that provide at least the following: an organized index, product formula information, log book, conditions and surveillance of the compounding environment, compounding procedures and requirements, training requirements for all staff, cleaning, QA plan with a BUD (Beyond Use Date/expiration date), product labeling, shipping and delivery procedures, pharmacist final verification, and safety procedures. IV admixtures made for a specific patient does not need to comply with the worksheet or log book requirements if it can still be tracked for recall purposes. The pharmacy must keep records on site and organized for 3 years.
Are there any requirements for purchasing bulk chemicals?
Bulk chemicals need to be purchased from an outlet registered by the Board. The bulk chemicals must also have a certificate of analysis and labeling that shows the date obtained and the BUD. The BUD cannot be greater then 5 years from opening, unless tested to extend the BUD by no more then 1 year.
What is the expiration date of low risk sterile preparations?
Without sterile testing; at room temperature the BUD can be up to 48 hrs, under refrigeration the BUD is up to 14 days and under frozen conditions (-20 degrees C) the BUD is up to 45 days.
What defines medium risk conditions?
These conditions meet the same conditions as low risk conditions and include 1 or more of the following; multiple sterile products are combined, will be administered to multiple patients, will give to one patient multiple times, requires complex aseptic manipulations, and a long duration to compound.
What is the expiration date of medium risk sterile preparations?
Without sterile testing; at room temperature the BUD can be up to 30 hrs, under refrigeration the BUD is up to 9 days and under frozen conditions (-20 degrees C) the BUD is up to 45 days.
What defines high risk conditions?
CSPs are classified as high risk for any of the following reasons: compounded from non-sterile ingredients (manufactured products intended for other routes of administration) or a non-sterile device is used before terminal sterilization. If exposure to an environment that does not meet ISO 5 for greater than 1 hour and the product lacked effective antimicrobial preservatives. If the non-sterile procedures (mixing or weighing) occurred in an environment that does not meet ISO 7 or personnel is improperly gloved or gowned. If water containing preparations are stored for more then 6 hours.
What is the expiration date of high risk sterile preparations?
Without sterile testing; at room temperature the BUD can be up to 24 hrs, under refrigeration the BUD is up to 3 days and under frozen conditions (-20 degrees C) the BUD is up to 45 days.
What are the requirements of an immediate use sterile preparation?
It is classified as a low risk compound provided: It doesn’t contain hazardous material, the compound has less then 3 sterile ingredients, involves simple manipulations, is completed in one sitting, and will be administered within the hour. They can be prepared in the following conditions; must use aseptic manipulation, use sterile ingredients and devices, but does not need to meet ISO 5 conditions and does not need to wear gloves or gown.
What are the requirements for same day use sterile preparations?
The compounded product must be administered within 24 hours of preparation. The compound may be classified as low or medium risk classification if it is prepared using sterile ingredients and devices and has ISO 5 or better environment. Other environmental requirements are a mixing cabinet with restricted air flow, a partitioned area around the cabinet (“buffer zone”) that is clearly identified and the area is cleaned daily with low particle counts and free of cardboard boxes/clutter. Preparations must be completed in 1 sitting, may not exceed 8 CSPs per batch, use gloves, appropriate gown and mask with hair and shoe covers, and single dose ampoules are not reused.
What is the expiration of a multi-dose vial?
The BUD is 1 month from first usage or the manufacturer expiration date, whichever is earlier.
What equipment do I need to make a low-risk sterile preparation?
Starting January 1st, 2009 an ISO 5 or better BSC (biological safety cabinet), CAI (compounding aseptic isolator) or LAF (laminar airflow hood).
What equipment is required to make a medium-risk sterile preparation?
Starting January 1st, 2009 an ISO 5 or better BSC, CAI or LAF can be used. A BSC or LAF can be used in an ISO 7 or better buffered room that is attached to an anterior room with ISO 8 or better. CAI’s may be used in an ISO 8 or better environment. These areas must have positive air flow pressure.
What equipment is required for high-risk sterile preparations?
Starting January 1st, 2009 it will require the same standards as medium-risk sterile preparations (see above).
Are there requirements on how frequently the compounding room must be cleaned?
All work surfaces and floors must be cleaned at least daily in ISO 7 and 8 areas. All other surfaces in these areas (shelving, walls, ceilings) must be cleaned monthly. The cleaning solution should be a high-level disinfectant or you may alternate regularly between medium-level disinfectants. These areas must be checked and certified by a qualified person at least every 6 months and when alterations have been made to the area.
What needs to be documented on the formula worksheets?
All documents of preparation, verification and dispensing/transfer must be kept for 3 years and contain the following information; Drug name and strength, quantity made, date prepared, pharmacy unique lot number, ingredients, manufacturer lot numbers with their expiration dates, BUD, verification and the name of the verifying pharmacist, names of all technicians involved, copy of the label used for the compounded product (or a system to identify batches of prescriptions), mixing instructions, physical evidence of the proper weight of each drug used, and certification of completion of any additional testing that may be required.
Are there specific requirements for using hazardous drug materials?
You are required to follow state and federal laws, there are no additional stipulations specified in division 45. Contact the EPA (www.epa.gov/) and OSHA (www.osha.gov/) for further information.
What does CSP stand for?
Compounded Sterile Preparation. It incorporates anything compounded in an IV room (prepared sterile products under manufacturers’ guidelines in an environment with possible exposure to contamination) or preparing with non-sterile components and devices that must be sterilized before administration.
What additional policies and procedures are required for sterile compounding?
You must follow the requirements described in question 10, but also ensure an appropriate BUD with end product testing and random sampling of the environment and CSPs when it’s appropriate. The PIC needs to have a QA plan in writing with records requiring the cleaning, testing and calibration of all equipment.
Do I need to perform random end product testing?
It depends, if you are mixing high risk CSPs or wish to extend the BUD, you would be required to perform end product testing. The BUD must not exceed USP 797 guidelines unless quality is verified by end product testing.
What needs to be on the label of sterile parenteral products?
The labeling requirements include all of the regular items (patient name, etc…), but also require the following: Rate of infusion, BUD, storage requirements, ingredients information (name, quantity and concentration of all ingredients including primary solution), and initial of pharmacist who verified it.
Can I reassign a parenteral admixture to another patient?
Yes, as long as it has been stored properly and the BUD has not lapsed.
What defines low risk conditions?
An ISO Class 5 environment or better, no more than three commercially manufactured sterile products placed in 1 container, and limited manipulations
When a prescriber writes a new prescription for a controlled substance but requires the destruction of a previously prescribed controlled substance prior to the new medication being dispensed how does a pharmacist go about fulfilling the request?
A pharmacist cannot accept the return of a controlled substance. A pharmacist can witness the patient destroying the medication (adding controlled substance to kitty litter or coffee grounds inside water water bottle then throwing it away) and document that the medication was destroyed prior to the new medication being dispensed.
Does a residential care facility need to report the disposal of controlled substances that were prescribed for residents to the DEA or the Oregon Board of Pharmacy?
No.
Who will take back controlled substances for destruction?
Reverse distributors. There is a list of them on the Oregon Board of Pharmacy website under Forms- click on “controlled substance destruction firms”.
What should a pharmacy do with broken controlled substance tablets?
Keep a dual or joint destruction log and document what was destroyed, date of destruction and who witnessed it.
Does the DEA allow the return or destruction of controlled substances to the pharmacy after dispensing?
No, except in the case of errors. See 21 CFR 1307.21.
What are the requirements for filing controlled substance prescriptions?
See CFR 1304.04.
When a pharmacy has a change in PIC and is required to do a controlled substance inventory can they make it the annual inventory as well?
Yes, but the next controlled substance inventory must be within 365 days.
How often does a complete controlled substance inventory have to be done?
Annually (within 365 days) and with each change in PIC.
Can the controlled substance count be corrected on inventory?
Yes, if diversion is suspected then the pharmacist must investigate and report it to the Board. The working copy should be kept so corrections made are documented and gives a clear picture of what occured.
What are the most common drugs left off the controlled substance annual inventory in pharmacies?
Pseudoephedrine products (esp. Zyrtec-D), phenylpropanolamine products and ephedrine products.
Can someone other than the PIC perform the annual controlled substance inventory? Can it be done without the PIC being present (i.e. on vacation)?
Yes to both, but the PIC is responsible for its accuracy.
Do pharmacies applying for a DEA license have to apply for an Oregon controlled substance license first?
Yes, they must apply for both a DEA license and an Oregon controlled substance license. The DEA will not release the DEA license until the Oregon Board of Pharmacy has issued the Oregon controlled substance license.
What is required on the DEA 222 form when controlled substances are checked in?
The date and quantity of medication received is required to be recorded on each line (including initials of the person checking in the controlled substances) of the DEA 222 form. All of the previous requirements for a DEA 222 can be applied to electronic/CSOS 222s.
Is ID required for picking up controlled substances from the pharmacy?
No, but the pharmacy can choose to require it.
Do colleges/ research facilities that have an FDA research license also have to have a DEA license to possess controlled substances? Do they need a license from the Oregon Board of Pharmacy?
Yes, they need a DEA license. The Oregon Board of Pharmacy may waive the requirement for registration with the State of Oregon.
Is there an age requirement to pick up a controlled substance?
No.
What is required to be on the hardcopy of a controlled substance prescription?
A prescriber’s name, address, DEA number, and the patient’s name and address must be on the hardcopy of a controlled substance prescription. These may be printed on the dispensing label placed on the back of the prescription. The CII prescriptions must also be hand signed by the prescriber. The pharmacist does not need to cancel the prescription across its face.
What is required to be on an escript of a controlled substance prescription?
A prescriber’s name, address, DEA number, and the patient’s name and address must be on the esccript of a controlled substance. These may be printed on the dispensing label and placed on the back of the prescription. The scheduled prescriptions must contain a digital signiture with authentification of the prescriber defined in 21 CFR 1311. (10-45) and recipients of digitally signed controlled prescriptions are to follow the requirements for validating scheduled prescriptions under 21 CFR 1311. (50-100).
How long are CII prescriptions good for? CIII-V? Regular legend medications?
CII- A CII prescription has no expiration date. It is up to the professional judgement of the pharmacist to determine if the prescription is in proper context and is still needed by the patient. CIII-V- 6 months or 5 refills whichever is sooner. All regular legend prescriptions- up to 1 year based on how the refills are written.
What schedule is methamphetamine?
It is a CII if it is in the form of an FDA approved product and is prescribed for a currently accepted medical use. Street use methamphetamine would be considered a schedule I drug.
If a controlled substance prescription was inadvertently transferred to the wrong pharmacy, can it be transferred to the correct pharmacy?
Yes.
Why do Canadian pharmacies sell prescription medications for so much less to US patients? Is it legal to fill Canadian prescriptions in the US? Is it legal to have a US prescription filled by a Canadian pharmacy?
Canada has a governing body similar to the US FDA; however, their governing body only requires them to sell “FDA” approved drugs to Canadian patients. This means that Canadian pharmacies can import drugs that are nonstandarized and unapproved from other countries to sell at reduced prices to nonCanadian patients (aka Americans). It is not legal to fill a Canadian prescription in the US. There are no Canadian pharmacies licensed with the Oregon Board of Pharmacy, so they cannot legally ship prescription medications into Oregon.
How many CE hours will you get for attending a Board meeting?
2 Hours per day or 1 hour for a half day of law CE.
How many CE hours will you get for attending a PIC class?
2 hours of law CE.
Where can a pharmacist or technician go for free CE?
Online at PowerPak or CECity or simply Google “Pharmacy CE” for additional opportunities.
How long should I keep my CE certificates?
3 years for pain CE and at least 1 year for regular CE. It is encouraged to keep all CE records for 3 years.
What are the requirements for yearly continuing education for pharmacists?
15 hours per year, at least one hour must be earned in the area of drug law and effective from June 1, 2011, at least one hour must be earned in the area of patient safety or medication error reduction
What is the Health Professional ‘s Service Program?
It is the impaired health professional program established by the Oregon Health Authority in July 2010. The Board may refer Pharmacists to this program if they believe that a Pharmacist has been impaired by alcohol, has a substance abuse disorder or dependency, or has a mental-health disorder.
How should a hospice nurse dispose of narcotics in the home after a patient passes away?
Joint destruction with documentation. Refer to the Department of Environmental Quality (DEQ) for eco-appropriate ways.
How should medications safely be disposed of?
Contact the Department of Environmental Quality (DEQ) or crush med, put in milk jug, dissolve in water, add clumping agent such as kitty litter and put lid on it to throw it away. Never throw medication away in its original container.
If a pharmacy employee is convicted of a drug related felony, is there anything a drug outlet needs for that employee to work for them?
The pharmacy employee may work in the pharmacy only if the drug outlet obtains a waiver from the DEA that allows access to controlled substances.
Will there be discipline if a notice of noncompliance is received?
In most instances there will be.
What is the lowest form of discipline that does not give probation or fines, but is reportable to clearinghouses?
A reprimand.
What quantity of CII medication can be dispensed to get a hospice patient through an emergency period when the pharmacist is unable to contact the prescriber?
Whatever quantity is needed to get the patient through the emergency period, after obtaining an emergency verbal prescription from the prescriber.
What is Expedited Partner Therapy (EPT)?
It is treating all sexual partners for certain sexually transmitted diseases, even when the treating practitioner has not examined those partners. OAR 855-041-04000
Is an EPT prescription valid if the name of the patient it is intended for is not on the prescription?
Yes
Can a practitioner write an EPT prescription for any antibiotic or any sexually transmitted disease?
No. It must be one of the drugs and diseases listed on the established DHS protocols.
How long is an EPT prescription good for? Can it be refilled?
30 days from the date written with no refills.
Can a pharmacist fill an EPT prescription for the patient without their name on it?
Yes. The pharmacist is not required to obtain an EPT patient’s or partner’s name, address or demographics.
Is a pharmacist expected to do a DUR or give counseling for EPT prescriptions?
Yes. The pharmacist must at least make an effort to obtain the patient and partners drug allergies and concomitant drugs. Also, written information about the drug must be given with each prescription.
How long does the Oregon Board of Pharmacy require prescription records and other records to be kept?
3 years (unless prescriptions are electronically scanned in and a reproducible image is available, then 120 days for all noncontrolled prescriptions and 3 years for all controlled substance prescriptions). The DEA requires prescription hardcopies of controlled substances to be kept for two years. Pharmacies may want to keep records longer (i.e. 7 years +) for Medicare requirements/audits etc.
Regarding HIPPA, can pharmacy benefit manager (PBM) billing info be e-mailed to someone’s home address in order to work on billing from home?
Probably not since it wouldn’t be secure, however, BOP does not regulate the HIPAA rules. Contact HIPAA at phone: 503-947-5255 or website: www.oregon.gov/DHS/admin/hipaa/index.shtml .
If a prescriber requests a patient’s pharmacy records, can a pharmacist provide them and not violate HIPAA?
Yes, as long as the request is within the normal course of business, because both the prescriber and the pharmacist are part of the healthcare team caring for the patient.
If the Oregon Board of Pharmacy requests information about a patient or other co-workers, can the pharmacist or technician provide this information and not violate HIPAA?
Yes, the Oregon Board of Pharmacy is grouped into a category with other enforcement/ regulatory agencies who are exempt from HIPAA. These privileges are given so that the Oregon Board of Pharmacy can complete investigations.
Who enforces HIPAA?
The Office of Civil Rights. http://www/hhs/gov/ocr/privacy/
How can someone feel reasonably confident that a particular internet pharmacy is legitimate?
The website should have a VIPPS (Verified Internet Provider Practice Site) symbol on it which means that the National Association of Boards of Pharmacy has inspected them and determined that they are a legitimate internet pharmacy provider.
Does a unit-of-use product (i.e. inhaler, ointment) require a product identification label?
No.
When does a correctional facility have to be licensed with the Oregon Board of Pharmacy?
If they have non-patient specific stock medications, they must be licensed with the Board. If they are just “storing” patient specific meds, they do not have to be licensed with the Board.
Do I have to pay for certified copies of my license?
You can request up to 2 certified copies free of charge at the time of your license renewal. Additional copies or copies at other times of the year will cost $5.00 each page of two.
When do out of state pharmacists need to be licensed by the Oregon Board of Pharmacy?
Beginning April 1st 2009, any pharmacist in a state outside of Oregon that engages in the practice of pharmacy for patient specific activities such as MTM, MRR, collaborative therapy, therapeutic interchanges must be licensed by the OBOP.
Who should a potential counterfeit medication be reported to?
The FDA
Who should a severe medication adverse event be reported to?
Medwatch
What should someone do if their regular medication looks different (i.e. different color or shape)?
Verify that the medication matches the description product identification label (PIL). And contact the pharmacy/pharmacist to ensure the medication is correct if different from the PIL or if they have additional questions.
What does the law say about prescribers writing prescriptions for medications, including controlled drugs, for family members?
There are no laws prohibiting prescribers from writing prescriptions for controlled substances for family members unless the prescriber’s license prohibits it. The prescriber’s licensing board should be notified of excessive use.
Can pharmacists order and/or authorize lab tests?
Yes.
Does a distributor of blood bags need to be licensed by the Oregon Board of Pharmacy?
The Oregon Board of Pharmacy does not regulate blood products, even with the anticoagulant in it.
What are the restrictions on dispensing Iodine or iodides?
There is no restriction on tincture of Iodine or iodides if it is under the allowable 2.2% of elemental iodine. Anything over 2.2% is restricted.
What is ISMP?
The Institute of Safe Medication Practices which is dedicated to medication error prevention.
Can non-veterinarians write prescriptions for animals?
No, non-veterinarians writing prescriptions for animals is beyond their scope of practice.
What schedule does marijuana fall into and can it be used legally for medical use in Oregon?
It is a Schedule II: however, the Oregon Board of Pharmacy does not regulate the medical use. That falls under the Department of Health and the Oregon Medical Marijuana Program (971-673-1234)
What is the NABP clearinghouse?
The place that the National Association of Boards of Pharmacy uses to check whether or not there are past, current or pending actions on a licensee in all states that they have practiced in (i.e. the Oregon Board of Pharmacy will find out information from the NABP regarding disciplinary action for pharmacists that want to reciprocate from other states).
What does it mean to “depot” drugs?
A pharmacy can store a prescription from another licensed prescription drug outlet in their pharmacy for a patient to pick up (i.e. usually occurs in remote locations). Prescriptions can also be “depoted” at the prescriber’s office (NOT the prescriber’s home), the hospital or medical care facility in which the patient is receiving care, the patient’s workplace, an alternate residence designated by the patient, the
Is Ultram a controlled substance in OR?
No.
What is a prescriber’s scope of practice?
An MD or DO can write prescriptions for anything other than veterinary medications. Other prescribers must prescribe within the limits of their practice (i.e. a dentist could not prescribe an eye drop).
Is my pharmacy required to have a separate counseling area?
Not necessarily, but it is the responsibility of the pharmacist or intern to provide a counseling environment that is confidential and maintains patient confidentiality.
How do I obtain a copy of the OBOP quarterly newsletter?
The Oregon Board of Pharmacy’s official Newsletter can be subscribed to by sending an e-mail to the National Association of Boards of Pharmacy, with only the word “Subscribe” in the subject heading to: [email protected]
If I don’t have a computer, will I still be held accountable for the information the Board Newsletter contains?
Yes, it is the Board’s primary form of communication to all licensees.
What is the Strategic National Stockpile (SNS)?
It is the US Government stockpile of antiviral drugs and other drugs and medical supplies that can be made available to a state in an emergency.
When is it okay for a pharmacist to dispense a drug refill without a valid prescription?
When there is a declared emergency or the patient and pharmacist are in an area engaged in disaster assistance. The following criteria must also be met: a) In the pharmacist’s professional judgment, the drug is essential to the maintenance of the patient’s health or the continuation of therapy; and (b) The pharmacist provides no more than a 30-day supply; and (c) The pharmacist records all relevant information and indicates that it is an Emergency Prescription; and (d) The pharmacist informs the patient or the patient’s agent that the drug
When can a pharmacist dispense a new or modified drug therapy?
A pharmacist in the area covered by a declared emergency or in an area engaged in disaster assistance may, after consultation with any authorized prescriber, initiate or modify any drug therapy, and dispense an amount of the drug to meet the patient’s health needs until that patient can be seen by a health-care practitioner, provided that: (a) The pharmacist acts in accordance with currently accepted standards of care; and (b) In the pharmacist’s professional judgment, the drug
If a prescriber dies or retires and surrenders their license, are the prescription refills still valid?
Since there is no longer a patient/ prescriber relationship the refills become invalid. A pharmacist should use good professional judgment and encourage the patient to seek a new care provider. A general rule would be one to two month supply.
Who is responsible for pharmacy security?
The PIC and the pharmacists on duty are responsible for adequate protection against theft and diversion. They are also responsible for supervising all pharmacy personnel (ensuring that they are working within their scope of practice) and making sure the pharmacy is compliant with all state and federal laws (only a pharmacist can have a key/access to the pharmacy when closed). If a violation does occur or drugs are
How long does a pharmacist, technician or intern convicted of misdemeanor or a felony or arrested for a felony have to report the information to the Board?
10 days
How long does a pharmacist, technician or intern have to report a change in employment or resident address to the Board?
15 days
How long does a pharmacist, technician or intern have to report misconduct of a licensee to our Board or another regulatory Board if applicable (i.e. RN misconduct reported to Nursing Board)?
It should be reported without undue delay and not later than 10 days after learning of the misconduct.
When must a pharmacist or technician report an arrest for a misdemeanor?
If not convicted, arrests for misdemeanors must be reported to the Board upon renewal of license.
Can you transfer a prescription to Canada?
No
At what age may a pharmacist administer a vaccination to a patient per current protocol?
The patient must be at least 11 years old and it must be in accordance with the protocol determined by the Oregon Health Authority. The pharmacist may also vaccinate a patient outside of the State protocol if instructed to administer a vaccine pursuant to a valid prescription
Who must a pharmacist report vaccine-related adverse events to?
To the Vaccine Adverse Event Reporting System (VAERS) and to the patient’s PCP
Does the immunizing pharmacist have to notify the patient’s PCP after giving an immunization?
No, but they must ensure that required information is reported to the OHA ALERT immunization system
How long does a pharmacist have to report to the required immunization information to the OHA ALERT immunization system?
15 days- this replaces the former requirement to notify the patient’s PCP
Does a pharmacy need to track how drugs are accounted for and wasted in an Automated Distribution Cabinet (ADC)?
Yes, there must be a policy and procedure for this and a QA plan to track it.
Can ADC’s be stocked with CII’s?
Yes.
Is it okay for the list of the drugs contained in the code cart to be located solely on the top of the tray located within the code cart?
No, the list must be affixed to the exterior of the code cart.
What is a CPO?
The Chief Pharmacy Officer (CPO) is the pharmacist who supervises the pharmacy operations in the hospital. They may be the PIC if there is only one pharmacy in the hospital or they may manage several PICs if it is a health system with multiple pharmacies.
Can emergency rooms dispense more than a 24 hour supply of medication to ER patients? Can they do so at times when the regular hospital pharmacy is open?
Yes, enough medication may be dispensed to the ER patient to get them through the emergency period as defined by the facilities policies and procedures. The amount may not exceed a 48 hour suppy except for unit-of-use packaging or full courses of therapy as determined by the RPh’s professional judgement. The emergency supply can be dispensed at any time of the day from the emergency room prepacks.
How often does a perpetual CII inventory have to be reconciled?
Monthly.
Can IVs be prepared in batches with the use of a log documenting the date prepared, technician preparing, pharmacist checking, drug, amount compounded, expiration date, and the commercial product used?
Yes, IV’s may be batched, but a pharmacist’s initials must be on final IV label for each one.
Under what circumstances may a patient use a drug brought to the hospital from home?
If, in the pharmacist’s professional judgment, withholding the drug would be detrimental to the patient’s health. The practitioner or pharmacist must first identify it, assure that it is in a labeled container and it must be pursuant to a practitioner’s order.
Who can repackage and label from bulk to unit of use?
A pharmacist or technician can do so; however, a pharmacist must verify, initial and keep a log for verification purposes.
In rural areas, is it ok for retail pharmacies to supply drug inventory to a local hospital’s drug room without the pharmacies having an IP license?
Yes, they would sell it to the hospital on invoice and use a DEA 222 form to transfer CIIs. Also, the hospital’s drug room pharmacist consultant must be doing QA and monitoring activities.
How many registered nurses per shift may have access to the night cabinet?
One- and they must be designated in writing and receive proper training prior to getting access to the cabinet.
How often do perpetual inventory sheets, sign out sheets or other dose-by-dose documentation of CII’s need to be randomly sampled?
At least quarterly.
How long do pharmacy records have to be stored onsite and retained?
They must be stored on site for at least 1 year and retained for 3 years. After the first year, records may be stored at a secure, off-site location if retrievable within 3 business days.
Does a secondary storage area such as a cath. Lab attached to the main hospital by a sky bridge require a separate license?
No However, a secondary storage area in a separate location (i.e. not attached to the hospital) must be registered as a drug room.
Can CII’s be stored in the robot if there is adequate security to limit access to designated employees?
No, but CIII – CV’s can be stocked in it.
Who may stock the robot?
pharmacy technician, certified pharmacy technician, intern or pharmacist
What is the difference between a remote storage area and a secondary storage area?
A remote storage area is a patient care area which is under the control of the hospital’s central pharmacy, but is not located in the same building (i.e. cath. lab that is across the sky bridge). A secondary storage area is an area in the hospital, supplied by the central pharmacy, that may include facilities such as a drug room, a distribution cabinet or a hospital department/nursing unit.
What is a TPI?
It is a Traditional Pharmacy-practice Internship in which the intern may not function as such until they have satisfactorily completed their first academic year in pharmacy school. TPIs may receive monetary compensation for their work.
What is an SRI?
It is a School-based Rotational Internship in which the intern receives school credit rather than getting paid. They may not work more than 48 hours per week in SRIs.
Can an intern perform a DUR?
Yes, if the intern feels comfortable with their knowledge base and has the pharmacists’ permission (the pharmacist and intern are responsible for the actions of the intern). Pharmacists and interns are the only employees that may perform/pass/enter through a computer DUR. A technician may not clear or pass any halt due to a DUR, even if the next screen provides the DUR information in detail.
Can 2 TPI’s work under the same preceptor and get intern hours for it?
No, only one TPI would be able to claim the intern hours. The other student could work doing only technician/clerk functions and would not receive any intern hours for the time worked. See FAQ regarding Community and Interns
Is an intern responsible for reporting unprofessional conduct to another licensee’s professional regulatory board?
Yes, and this information should be reported to the appropriate professional regulatory board within 10 days of learning of it.
Can interns that have graduated from pharmacy school and hold a pharmacy degree, but are not yet licensed as pharmacists use the title PharmD?
Yes, because PharmD is an academic term, but they cannot be called pharmacists (RPh) or perform the duties of a pharmacist until they have passed all exams, hold a pharmacy degree and are licensed by a Board of Pharmacy.
How long is my intern license good for?
New licenses are valid until the last day of November following the second anniversary of issue unless automatically terminated. Renewed license are good for 2 years unless automatically terminated.
How could my intern license be automatically terminated?
a) Licensure to practice pharmacy is granted in any state; or (b) The licensee, other than a foreign pharmacy graduate or an applicant for licensure by reciprocity, fails to maintain enrollment or active registration in a pharmacy degree program for a period greater than one year; or
How long do I have to surrender my intern license if it is automatically terminated?
30 days
When is an intern eligible to take the MPJE and NAPLEX?
After the Board is notified by the school that your degree, with not less than 1440 hours of SRI, has been conferred.
How long is preceptor license good for?
One year and it must be renewed concurrent with licensure as a pharmacist
Does my preceptor have to supervise all of my intern hours?
No. The preceptor just needs to supervise the majority of the interns hours. Another pharmacist can supervise the intern while the preceptor is not there (i.e. vacation, days off etc.).
Does a preceptor have to keep documentation tracking a TPI’s intern hours?
No the intern is responsible for documenting the hours they plan to claim. However, it is a good standard of practice for all preceptors to check the hours their intern has documented for accuracy.
How many interns can a preceptor supervise for direct patient care?
TPI- 1 intern, SRI- up to 2 interns
Is there ever a time where a preceptor can supervise more 2 interns at a time?
Yes, a preceptor may supervise up to 10 interns for public health outreach programs that do not involve direct patient care. The preceptor should use professional judgment to determine if and when this is appropriate.
If an intern is arrested for a misdemeanor, when must they report the information to the Board?
If not convicted, an intern must report the arrest when either renewing their intern license or applying for a new application to practice pharmacy.
Can an intern provide immunizations?
Yes, if the intern is trained to do so (immunization qualified and current CPR certification) and comfortable providing the service. The pharmacist supervising must also be immunization qualified through training accredited by the CDC, ACPE or similar health authority approved by the Board and have current CPR certification.
Does DEA recognize a LTC nurse as an agent of the practitioner for CIII through CV drugs?
No
What is the expiration date for “salad packs”?
60 days from the date they were filled.
What is the expiration date for bubble packs with 1 chemical entity in each bubble?
1 year or the manufacturer’s dating if sooner.
Do product identification label requirements need to be followed for bubble packs and “salad packs”? (855-041-0065)
Yes.
Can medications used in a hospice setting be used as house supply if the resident has left or expired?
No.
When do long term care pharmacies have to assist in the establishment and supervision of the policies & procedures for the safe storage, distribution, administration & disposition of drugs, for professional advice/medication counseling of patients and/or caregivers, and documenting the quality assurance activities?
If they are: 1) the primary provider for the long term care facility or 2) they are a contracted pharmacist consultant for the long term care facility or community based care facility or 3) they are accepting medication back for redispensing or 4) they are supplying an emergency drug kit to the long term care or community based care facility, they must comply with these rules. If they are a secondary provider for a long term care facility, they must confirm that the primary provider or consultant is doing these things for them and their patients or the secondary provider must do this for their own patients.
When can bubble packed long term care medications be returned and re-dispensed?
When all of the following criteria are met: 1) the drug is in an unopened tamper-evident unit, 2) the drugs or devices have remained at all times in control of a person trained and knowledgeable in the storage and administration of drugs in long term care facilities or supervised living groups using the services of a consultant pharmacist, and 3) the drug or device has not been adulterated or misbranded and has been stored under conditions meeting United States Pharmacopeia standards. Medications must be credited to the patient account prior to repackaging to be use for another patient.
Can medications that are “salad packed” (2 different chemical entities in each bubble) be returned and re-dispensed?
No, they can be returned for destruction only, provided that the salad pack contains no controlled substances.
Can controlled substances be returned to the pharmacy?
No, they must be destroyed at the site.
Can a retail pharmacy accept the return of controlled substances from a jail or long term care facility?
No, controlled substances must be destroyed on site.
If medications are sent out to the long term care facility or community based care home, but never reach the patient, can the medication be returned to the pharmacy and reused?
Yes, as long as no more than 1 chemical entity is in each bubble.
What circumstances only require the PIC to be licensed in the state of Oregon?
Out of state pharmacies that only mail prescriptions directly to patients are only required to have the PIC (or similar position) licensed with Oregon and does not require other employee pharmacists to be licensed.
When can I retake the NAPLEX or MPJE if I fail to get a score of 75 or greater?
You must wait at least 91 days to retake the NAPLEX and at least 30 days to retake the MPJE.
How do I transfer my NAPLEX score?
You must request a score transfer from the NABP (National Association of Boards of Pharmacy) BEFORE taking the exam, be a graduate of a school/college of pharmacy approved by the board of pharmacy, and provide documentation (Oregon score transfer application, passport photograph, copy of birth certificate, and evidence of pharmacy school graduation).
What are the requirements of a pharmacist if he wishes to reciprocate to Oregon?
You must have an active license in good standing with the state you wish to reciprocate from, have passed the NAPLEX (score 75 or greater) and have a pharmacy degree from a school or college approved by the Board. You are required to have worked for a period of at least one year (with a minimum of 2000 hours) in the state of current licensure or met the internship requirements of Oregon within a year of application. You are also required to pass the MPJE with a score of 75 or greater. A pharmacist with their first professional degree outside of the United States is ineligible for reciprocity and must follow the requirements set forth in OAR 855-019-0150.
Can a licensed pharmacist in another state practice as an intern in Oregon?
No, unless the pharmacist is requesting to reciprocate to Oregon and requires additional work experience hours. Even then, they still must apply for and receive an Oregon intern license from the Board before working as an intern in Oregon. More work experience is required if they haven’t worked for at least 1 year (with a minimum of 1440 hrs) or completed the required internship hours (completed 1440 hrs within 1 year prior to application). Note: hours completed outside of the United States can not be used toward the required 1440 hrs.
What can an out of state licensed pharmacist do in Oregon while awaiting reciprocity approval?
The Pharmacist is able to perform the duties of a clerk and if they obtain a technician license they may perform the duties of a technician, but they MUST obtain a technician license through the Board. They may not perform any activities reserved for a licensed pharmacist (Counsel, DUR, MTM, verification, etc…).
When I reinstate my license do I need to pay the licensing fees for all of the years I was not licensed?
You must pay the licensing and late fees for all the years the license has been lapsed and have all CE requirements met for the lapsed years. If the time lapsed is greater then 1 year, you must also take and pass the MPJE. However, if you are a retired pharmacist that was licensed for at least 20 years (or if you had your license revoked by the Board) you are only required to pay for the current annual licensing fee, pass the MPJE, and have CE for all years since retirement.
What are some reasons that would cause the Board of pharmacy to suspend a license?
The Board can revoke, suspend, or restrict a pharmacist, intern, or technician license for various reasons, such as; unprofessional conduct, violating a pharmacy or drug law, a felony, engaging in fraud, inability to perform your job, or being negligent. A partial list of reasons can be seen in OAR 855-019-0310.
If my license is revoked, suspended or restricted by the Board can I ever get it reinstated?
Potentially, but the Board must find that the public interest will be protected if you are reinstated. You must prove this by giving various documentation and presentations showing how the current situation has changed since revocation. A complete list of requirements is listed in OAR 855-019-0320. It is important to note that for every case, even if all Board recommendations were satisfied, the Board must determine that the petitioner is not a threat to public interests if a license is reinstated.
Are there any specific requirements to be a PIC?
You must have at least 1 year experience as a pharmacist or complete the PIC training course approved by the Board within 30 days of becoming a PIC. You must also notify the Board within 15 days of becoming a PIC or resigning as the PIC. You can not be a PIC of more than 2 pharmacies, unless there is written approval from the board.
As the PIC what am I responsible for?
The PIC is responsible for the full operation of the pharmacy. Some specific requirements are listed that the PIC must personally complete, while other requirements the PIC is responsible for may be delegated to qualified employees. A list of these requirements can be seen in OAR 855-019-0300.
Is it required to maintain a perpetual inventory of controlled substances?
It depends. It is required for C-II medications in hospital pharmacies (with a monthly inventory reconciliation), but a quarterly inventory reconciliation of all C-II’s must be done in retail pharmacies.Note: The annual controlled substances inventory is still required. It must be taken on one day before opening or after closing and occur no later than every 365 days.
What are the procedures that only a pharmacist is allowed to do?
Only a pharmacist can do the final verification on prescriptions. A pharmacist or a pharmacy intern (with the supervision and final approval of the pharmacist) may review laboratory tests (monitor, interpret, and/or order these tests), perform distinct pharmacist services (such as CDTM, DRR, or MTM), or execute other tasks that require professional pharmacist judgment.[Note: counseling, immunizations, DUR, and receiving oral prescriptions can all be done by a pharmacist or intern.
Do I need to perform a DUR for prescription refills?
Yes. A pharmacist or intern must perform a DUR prior to dispensing or preparing all prescriptions and orders even if the computer does not prompt them to do so.
Do I need to document my counseling interactions?
Yes, a pharmacist or an intern must personally document that counseling was accepted or declined after the interaction. A patient’s electronic signature for insurance purposes is not sufficient. A decline to be counseled on a prescription that is new or changed must be directly to a pharmacist or intern. Under NO circumstances may any customers’ refusal be accepted by a clerk or technician. For hospital discharge prescriptions, the pharmacist must ensure the patient receives adequate counseling.
Can I write a prescription based on CDTM?
Yes, a pharmacist can transcribe a prescription based on CDTM between identified pharmacist(s) (practitioner authorized) and practitioner(s), with filed documentation of the pharmacists’ activities and decisions/plan. The CDTM must be specific enough that any pharmacist would develop the same prescription; this should be accomplished by following the requirements laid out in OAR 855-019-0260.
Can I fill an internet prescription?
No. Oregon pharmacists are only able to fill valid prescriptions developed from a legitimate patient-practitioner relationship. Online questionnaires are NOT considered a valid and adequate patient-practitioner relationship.
Can I fill a prescription for a controlled substance if it was received electronically?
Yes, per new federal regulations a pharmacist may fill a prescription for a controlled substance if it was recieved electronically. See CFR 1306.08 for further details and guidance.
Do I need to print non-controlled electronic prescriptions or can I store them electronically?
Yes, you can store them electronically if they are non-controlled. OAR 855-041-0060 (1)(a) An “original prescription” is a prescription maintained in the same physical manner in which a pharmacy first receives the prescription.
Can I administer immunizations to children?
You can administer vaccines to patients that are age 11 or older based on the State protocol. You may adminsiter a vaccine outside the State protocol with a valid prescripton to adminster the vaccine.
Are there any other requirements to administer immunizations besides being immunization and CPR certified?
There are protocols that must be followed in order to administer immunizations. A list of these requirements is found in OAR 855-019-0280 and should be studied and implemented before administering vaccines.