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Pharm Law review
CSA Laws
| Question | Answer |
|---|---|
| Maintenance treatment = dispensing for a period in excess of ___ days of a narcotic drug. | 21 |
| Detoxification treatment = dispensing, for a period not in excess of ___ days, of a narcotic drug | 180 |
| What three things are the schedules for controlled substances based on? | 1- Recognition of medical use; 2- Potential for abuse; 3- Possibility of physical or psychological dependence |
| Dispensers have to register with the DEA. How long is their registration valid for? | 3 years (pg. 66) |
| Manufacturers and distributors have to register with the DEA. How long is their registration valid for? | 1 year (pg. 65) |
| Can C2 Rxs be refilled? | No |
| How long must controlled substance records be retained? | 2 years (pg. 68) |
| Can C2 Rxs be dispensed without a written prescription? | Generally, NO. Except in emergency situations. (pg. 68) |
| Can C3 Rxs be refilled? | Yes. However, max is 5 refills in 6 months. |
| Can C4 Rxs be refilled? | Yes. However, max is 5 refills in 6 months. |
| Can C2 Rxs be dispensed with an oral prescripton? | Generally, NO. Except in emergency situations. (pg. 68) |
| Can C3 Rxs be dispensed with an oral prescripton? | Yes. (pg. 69) |
| Can C4 Rxs be dispensed with an oral prescripton? | Yes. (pg. 68) |
| Can C5 Rxs be refilled? | Yes. (There is no time limit on these refills.) (pg. 69) |
| The opposite of a legend drug is ___. | non-prescription drug (pg. 70) |
| The opposite of a scheduled drug is ___. | non-scheduled drug (pg. 70) |
| First two letters of a DEA number signify ___. | Status of the registrant (pg. 70) |
| DEA numbers of practitioners and dispensers may begin with the letters ___. | A, B, or F (pg. 70) |
| DEA numbers of mid-level practitioners and dispensers may begin with the letters ___. | M (pg. 70) |
| DEA numbers of distributors may begin with the letters ___. | P or R (pg. 70) |
| How do you evaluate the legitimacy of a DEA number? | Add numbers 1,3,5. Add numbers 2,4,6 and double the result. Sum the above. The number in the sum in the ones column should be the same as the very last digit of the DEA number. (pg. 71) |
| Sometimes pharmacists may distribute controlled substances. Pharmacists do not need to obtain a separate registration as a distributor as long as ____. | the total # of dosage units is not more than 5% of the total units of controlled substances that is distributed and dispensed in one year (pg. 71) |
| Sometimes pharmacists may distribute controlled substances, and there is a limit before having to obtain a separate distributor registration. Sometimes a retail pharmacy distributes to ADCs at LTCFs. Do these count towards the limit? | No. The distributions to ADCs at LTCFs do not count toward the 5 percent limit. (pg. 72) |
| Which form is used to report theft or significant loss? | Form 106 (pg. 74) |
| Are prescribers who prescribe or administer controlled substances in the course of their practice required to keep records? | No. (pg. 75) |
| Can records be maintained offsite? | Yes, as long as certain conditions are met (pg. 75) |
| Describe the process for requesting permission to keep financial and shipping records at a central location? | Send written notification to local office, with a return receipt requested. You can start keeping records centrally 14 days after the office receives the notice, UNLESS the office contacts and denies you. (pg. 75) |
| Which records must always be maintained separately? | Inventories and records of C1 and C2 (pg. 76) |
| How must paper C2 prescriptions be stored? | In a separate prescription file (pg. 76) |
| How often must a controlled substance inventory be taken? | Every 2 years (pg. 78) |
| When taking inventories, can the amount of controlled substances be estimated? | If C1 or C2, and EXACT count must be made. If C3, C4, or C5, may use an ESTIMATED count, UNLESS the container holds more than 1,000 tablets/capsules (in which case you need to make an EXACT count) (pg. 78) |
| How do you order C1 and C2 controlled substances? | Must use form 222. (Pg. 79) |
| How do you order C3, C4, and C5 controlled substances? | Do not need any special form. (Pg. 79) |
| What is form 222 used for? | To order controlled substances C1 and C2 (Pg. 79) |
| How do you order additional form 222s? | Use form 222a. (Pg. 80) |
| Can unexecuted form 222s be stored elsewhere? | Yes. They may be kept at a location other than the registered location as long as they could be delivered to registered location upon request. (Pg. 80) |
| For form 222, who gets each of the 3 different copies? | Copy 1: supplier; Copy 2: DEA; Copy 3: purchaser (pharmacy) (Pg. 80) |
| Can an order on form 222 be partially filled by the supplier? | Yes, as long as the balance is supplied to the pharmacy within 60 days. The form is not valid after 60 days, UNLESS it is for delivery to armed services establishments (in which case the partial shipments can occur for up to 6 months after the date). Pg81 |
| If a supplier partially fills an order submitted on form 222, when must Copy 2 of the form be sent to the DEA? | It must be forwarded at the close of the month during which the final shipment is made or the 60-day validity period ends (Pg. 80) |
| When using form 222, what do the purchasers have to do when they receive their orders? | When controlled substances are received, they must be logged in on Copy 3 of the form. (Pg. 81) |
| One pharmacy wants to transfer controlled substances to another pharmacy. What form, if any, must the pharmacy use? | Form 222 (pg. 81) |
| What does CSOS facilitate/allow a pharmacy to do? | It permits pharmacies to order C1 and C2 drugs electronically from the supplier. (pg. 81) |
| What does 'corresponding responsibility' mean? | Requires that pharmacists carefully review each controlled substance prescription to assure its validity. (pg. 82) |
| What information should be on every controlled substance prescription? | Prescriber's name, address, and DEA registration number; Patient's name and address; Drug name, strength, dosage form, quantity; Directions for use (pg. 82) |
| Do pharmacists need to be individually registered with the DEA? | No. They do not need to be individually registered with the DEA as long as they are practicing in a pharmacy that is registered with the DEA. (pg. 82) |
| Retail pharmacies may install and operate an ADC at a nursing home. Do they need a separate registration at the location of the nursing home? | Yes. (pg. 84) |
| When can a C2 prescription be transmitted orally? | Emergency situations (pg. 84) |
| Describe the process for filling a C2 via oral prescription. | Pharmacist must write down the order; The amount filled and dispensed is only enough for the emergency period; Within SEVEN DAYS, the prescriber must deliver (or postmark) a written prescription to the pharmacist. (pg. 85) |
| After dispensing a C2 in an emergency situation via an oral prescription, what does the pharmacist do if the prescriber hasn't sent the written prescription? | Pharmacist must notify the neartest DEA office (pg. 85) |
| Can a C2 prescription be transmitted via fax serve as the original prescription?? | Generally, NO (pharmacist must get the written Rx before dispensing.) But YES for these: 1) to be compounded for direction administration, 2) for a resident of a LTCF, or 3) for a patient in a hospic program certified and/or paid for by Medicare (pg. 85) |
| Can a prescriber issue multiple C2 prescriptions on the same day for the same C2 drug? | Yes. Prescriber may authorize patient to receive up to a total of a 90-day supply. Each RX should indicate the earliest date it can be filled. (pg. 86) |
| Can a C2 prescription be partially filled? | Yes. The remaining portion must be filled within 72 hours, EXCEPT for patients in LTCFs or terminally ill (in which case the script must be filled within 60 DAYS) (pg. 86) |
| If a C2 has a partial fill, and the remaining isn't filled, what must the pharmacist do? | Pharmacist must notify the prescribing practitioner. (pg. 86) |
| Can a C3 prescription be transmitted via fax and it serve as the original prescription? | Yes (same for C4 AND C5) (pg. 88) |
| Can a C4 prescription be transmitted orally? | Yes (same for C3 AND C5) (pg. 88) |
| Can a C3 prescription be partially filled? | Yes, as long as it is within 6 months of the Rx issue date (same for C4 AND C5) (pg. 91) |
| Can a C2 prescription be transferred between pharmacies? | No. (pg. 92) |
| Can a C4 prescription be transferred between pharmacies? | Yes.(same for C3 AND C5) (pg. 92) |
| In order to be admitted to an OTP, how long must the patient have been addicted to the opioid? | 1 year. There are three exceptions: 1) released from penal institutions, 2) pregnant patients, and 3) previously treated patients (pg. 94) |
| What are the requirements of a person under 18yo to be admitted to an OTP? | Required to have had 2 document unsuccessful attempts at short-term detoxification within a year. (pg. 94) |
| What is the limit for the number of detoxification episodes per patient in an OTP? | Program shall no admit a patient for more than 2 detoxification treatment episodes in one year. (pg. 94) |
| When can someone be placed in interim maintenance treatment, instead of an OTP? | If the patient cannot be put into into a comprehensive program in a good geographical location within 14 days of the patient's application. |
| What are the daily and monthly product limits under CMEA? | 3.6 grams/day and 9 grams/month (pg. 97) |
| What is an SLCP? | 'Scheduled Listed Chemical Product'; contains ephedrine, pseudoephedrine, or phenylpropanolamine and may be lawfully distributed OTC. |
| Which form is used to register a pharmacy? | Form 224 (pg. 107) |
| What form is used to renew a pharmacy registration? | Form 224a (pg. 107) |
| How often must a pharmacy registration be renewed? | Every 3 years (pg. 107) |
| A pharmacy registrant can renew online no more than ___ prior to the current expiration date. | 60 days (pg. 107) |
| What is the form used to obtain an affidavit for renewal of retail chain pharmacy registration? | Form 224b; (pg. 107) |
| Must a pharmacy that moves to a new physical location request a modification of registration? | Yes (pg. 107) |
| A pharmacy that will be transferring its business operations to another pharmacy must submit certain items to the DEA office. How many days before the proposed transfer must this be done? | At least 14 days in advance of the proposed transfer (pg. 108) |
| When transferring a pharmacy to another pharmacy, a complete inventory is taken on the day of transfer. Must this inventory be sent to the DEA? | No (pg. 108) |
| What form is used to transfer controlled substances between two pharmacies? Which pharmacy issues it to whom? | Form 222; the RECEIVING pharmacy issues the form to the pharmacy that is transferring the drugs (pg. 108) |
| Is registration required for regulated sellers of SLCPs? | No, but regulated sellers must self-certify with the DEA (pg. 109) |
| Is registration as a chemical distributor required to wholesale distribute SLCPs? | Yes. (So retail pharmacies that are registered to handle controlled substances don't need to obtain a separate chemical distributor registration, unless they want to engage in wholesale distribution) (pg. 109) |
| A pharmacy may forward controlled substances to a reverse distributor who handle the disposal of controlled substances. Which form is used, and who issues it to whom? | Form 222. The reverse distributor issues it to the pharmacy. (pg 111) |
| T/F: Form 41 should be used to record the transfer of controlled substances between a pharmacy and a reverse distributor. | FALSE (pg 111) |
| Which form is used to document destroying controlled substances? | Form 41 (pg 111) |
| Can a pharmacy employ someone, who has been convicted of a felony related to controlled substances, and allow them access to controlled substances? | Generally, No. But the pharmacy may request an exception to this requirement for the employee. (pg. 111) |
| A theft or significant loss of controlled substances is discovered in a pharmacy. What must be done within 1 business day? | Notify the local DEA office in writing. Note that it is not specifically required by federal regulations to contact local police. (pg 111) |
| Which form is used to document theft or significant loss of controlled substances? | Form 106 (pg 111) |
| What should the pharmacy do if an investigation of theft or loss leads to a conclusion that no such theft or loss occurred? | Do not need to submit form 106. But must notify DEA in writing that no theft/loss has occurred in order to resolve the initial report that was reported to the DEA (to explain why a form 106 was not submitted) (pg 113) |
| Whose responsibility is it to determine what a 'significant loss' is? | The pharmacy (pg 113) |
| Part of a shipment of controlled substances is lost in-transit to a pharmacy. Who is responsible for reporting the loss? | The supplier (the pharmacy is responsible for reporting loss after it has taken custody of the shipment) (pg 113) |
| A central fill pharmacy uses a private company to carry filled Rxs to a pharmacy. Some controlled substances are lost in transit. Who is responsible for reporting the loss? | The central fill pharmacy, by filing a form 106 (pg 114) |
| T/F: The breakage or spillage of controlled substances constitutes a "loss" of controlled substances | False (pg 114) |
| What form is used to dispose of recoverable substances after a breakage or spillage? | Form 41 (pg 114) |
| T/F: Records and inventories of C2s do not have to be maintained separately from all other records. | False (pg. 115) |
| T/F: Records and inventories of C4s do not have to be maintained separately from all other records. | False. Must either be maintained separately or in a form that is readily retrievable. (pg. 115) |
| List the different options a pharmacy has regarding how to store prescription records. | Three options. 1) 3 files, one for C2, one for C3-5, one for all others; 2) 2 files, one for C2, one for C3-5 AND all others; 3) 2 files, one for C2-5 and one for all others. (pg. 241 Abood) |
| T/F: A pharmacy must submit a copy of its biennial inventory to the DEA. | False (pg. 117) |
| T/F: An executed form 222 must be maintained separately from the pharmacy's other business records. | True. However, the pharmacy is allowed to attach a copy of the supplier's invoice to the related from 222. (pg. 118) |
| When using a form 222, can a supplier substitute with identical product differing in packaging size from those that are initially ordered? | Yes, as long as the actual quantity the pharmacy receives does not exceed the amount initially ordered and that the NDC is that of the actual product shipped. (pg. 118) |
| How would a pharmacy/purchaser cancel an order (or partial order) on a form 222? | Notify the supplier in writing. (pg. 118) |
| How would a supplier void an order (or partial order) on a form 22? | Notify the purchaser/pharmacy in writing (pg. 118) |
| A pharmacy may grant a power of attorney to an individual to sign form 222. Who must sign the power of attorney? | Two people: 1) The same person who signed the most recent pharmacy registration application (or renewal application), and 2) the person that is being authorized to execute form 222. (pg. 118) |
| What should a pharmacy do if an form 222 order was sent, but the product was never received and the form was lost/stolen? | The pharmacy should complete a 2nd order form (so that the supplier can fill the original order), and the pharmacist must prepare a statement and attach it to the copy 3 from the first and second form 222s. (pg. 119) |
| What must a pharmacy do upon discovery of loss or theft of used or unused form 222s? | Must report loss to local DEA office immediately. (pg. 119) |
| A pharmacy/purchaser may use CSOS to order C2s. If an order is not filled, who is required to retain a record of such orders? | The purchaser must retain a copy of the voided order. The supplier is NOT required to do so. (pg. 120) |
| T/F: When a prescription is received electronically, the prescriptions and all required annotations must be stored electronically. | True. (pg. 123) |
| Is there a federal time limit within which a C2 Rx must be filled after being signed by the practitioner? | No. (pg. 125) |
| Is there a federal limit regarding the quantity of drugs dispensed via a prescription? | No. (pg. 125) |
| When a practitioner issues multiple C2 prescriptions on the same day for a C2 drug, what is the limit of days-supply? | 90 (pg. 125) |
| For a C4 Rx, is a fax considered to be equivalent to an original prescription? | Yes, as long as it is manually signed by the practitioner. (pg. 127) |
| Labels of some classes of controlled substances required that they contain the warning, 'Caution, federal law prohibits the transfer of this drug...'. Which classes of controls are they? | C2, C3, and C4 (pg. 129) |
| After authorizing an emergency C2 prescription orally, a practitioner must send a written Rx to the pharmacy. What phrase must be written on this written, signed prescription? | 'Authorization for Emergency Dispensing' (pg. 130) |
| After being approved for a modification of registration to also be an online pharmacy, does the pharmacy get a new DEA registration number? | No, it keeps the same DEA registration number (pg. 134) |
| A pharmacy will be offering controlled substances for sale, etc. via the internet. How many days prior to they have to notify the DEA? | 30 days. Must complete the 'Application for Modification of Registration for Online Pharmacies', which serves as the notification. (pg. 133) |
| What must an online pharmacy report monthly? | The total quantity of each controlled substance that the online pharmacy has dispensed the previous calendar month. This is for every month that the total amount is >100 Rxs filled OR 5,000 or more dosage units dispensed (pg. 135) |
| When is an online pharmacy's monthly report due? | On on before the 15th day of the following month (pg. 135) |
| Under the Ryan Haigh Act's definitions, does an online pharmacy include those that are limited to filling new and/or refilling Rxs for C3, C4, and C5? | No. So this pharmacy does not need to obtain a modification of its registration to operate as an online pharmacy. (pg. 135) |
| What form is used to obtain registration as a OTP? | Form 363 (pg. 138) |
| If a practitioner wants to prescribe and dispense C2 for maintenance and detox, what must they do? | Obtain a separate registration as a OTP, and get approved and specially certified (every 3 years according to Abood pg. 197) (pg. 138) |
| T/F: A practitioner who want to prescribe and dispense C3 for addiction treatment needs to register as an OTP? | False. (pg. 138) |
| If a practitioner wants to prescribe and dispense C3, C4, or C5 for addiction treatment, what must they do? | Request a waiver (DATA waiver). They can only treat 30 or 100 patients at any one time, and must include a special identification number on all records when dispensing and on all prescriptions when prescribing. (pg. 138) |
| What must a pharmacist do to report a loss or theft of SLCPs? | File a written report of losses within 15 days after becoming aware of the loss or theft. (pg. 141) |
| T/F: An biennial self-certification is required for all regulated sellers of SLCPs | False. It is an ANNUAL self-certification. (pg. 142) |
| Can a pharmacy place an emergency kit with controlled substances in a non-DEA registered LTCF? | Yes, as long as the state agency delineates the necessary rules. (pg. 145) |
| What changes to a prescription is the pharmacist never allowed to make? | Changed to the patient's name, controlled substance prescribed, or the prescriber's signature. (pg. 147) |
| Can a practitioner prescribe methadone for the treatment of pain? If yes, do you need any special registration? | Yes. But the practitioner only needs to register as an OTP if the methadone is being used for maintenance or detox treatment. (pg. 147) |
| How does a pharmacist document breakage or spillage that is NOT recoverable? | Two individuals who witnessed it must sign the inventory records and indicate what they witnessed. Form 41 is NOT required. (pg. 149) |
| Can an electronic prescription be printed (can a copy be made of it)? | Yes. May print copies of transmitted prescriptions if they are clearly labeled 'copy only - not valid for dispensing' (pg. 152) |
| Under electronic prescriptions, is a practitioner allowed to use a single signature to issue multiple prescriptions to multiple patients? | No. But the practitioner can sign multiple prescriptions for ONE patient at one time. (pg. 152) |
| Once an electronic prescription is signed, must it be transmitted to the pharmacy immediately? | No. (pg. 152) |
| How often must electronic prescription records be backed-up? | Daily (pg. 153) |
| How often must a third-party audit or certification of electronic prescription applications be conducted? | Every 2 years. (pg. 153) |
| Prescription records should be kept for ___ years. | 20 (Reiss pg. 91) |
| Do hospital pharmacies have to provide PPIs? | Yes, upon administration of the first dose and every 30 days after. (Reiss pg. 104) |
| T/F: Prescribers who dispense prescriptions from their offices are exempt from giving patients PPIs. | False. (Reiss pg. 104) |
| T/F: When preparing prescription refills, plastic container parts do not need to be replaced. | False. Plastic parts must always be replaced (Reiss pg. 98 |
| Which law requires that pharmacists offer to counsel patients? | OBRA 90 (Reiss pg. 124) |
| Patients in a community pharmacy have to sign a 'Notice of Privacy Practices.' How long does the pharmacy have to keep it? | For six years from date obtained OR from the last date a prescription is dispensed (whichever is later) (Reiss pg. 129) |
| People can import drug products for their own personal use. What is the supply limit on such drugs? | 3 month supply (Reiss pg. 129) |
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2029334