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MPJE review
Chapter 2: Controlled substances
| Question | Answer |
|---|---|
| What are examples of Schedule I controlled substances listed by Dr. C? | Heroin, LSD, peyote, mescaline, methaqualone, and certain other substances. |
| What are common drug/products that are C3? | Codeine combos (T3/T4/Fiorinal), Buprenorphine, Ketamine, Testosterone, anabolic steroids, anal barbiturates, paragoric, |
| What are common C4 drugs? | Benzos, modafinil (and derivatives), phentermine, carisoprodol, diethylpropion, suvorexant. |
| Which drugs are C5? | Pregabalin, ezogabine, lacosamide, certain codeine-containing products, certain opium-containing antidiarrheals, and others. |
| What well-known exempt prescription product does Dr. C list? | Foricet |
| What is a “listed chemical” under controlled substance law? | A chemical that has legitimate uses but can also be used in manufacturing controlled substances. Like Psuedofed |
| Who has federal authority to add, delete, or reschedule controlled substances? | The U.S. Attorney General, acting through the federal controlled-substance scheduling process. |
| Who has authority to add, delete, or reschedule substances under Texas law? | The Commissioner of the Texas Department of State Health Services, subject to statutory limits. |
| Can a pharmacy compound a narcotic controlled substance pursuant to a valid prescription? | Yes, subject to the law/limitations |
| What special federal restriction applies when a pharmacy compounds “aqueous or oleaginous solutions or solid dosage forms” containing narcotics? | The amount/concentration of narcotic cannot exceed specified limits unless the pharmacist has authority to manufacture the product. |
| Under federal law, what is the Schedule V concentration limit for codeine in qualifying compounded products? | 200mg/100mL |
| Under TEXAS law, what is the Schedule 3 concentration limit for codeine in qualifying compounded products? | 1.8g/100mL AND 90mg per dosage unit |
| What Schedule III concentration limit for codeine does Dr. C list? | 1800mg per 100 mL and 90 mg per dosage unit. |
| What are the schedule 3 and 5 limits for dihydrocodeine? | Schedule V: 100 mg/100 mL Schedule III: 1.8 g/100 mL AND 90 mg/dosage unit |
| What are the schedule 3 and 5 limits for opium? | Federal Schedule V: 100 mg/100 mL Texas Schedule V: 50 mg/100 mL Schedule III: 500 mg/100 mL AND 25 mg/dosage unit |
| When can morphine classify as a C3? | If its compounded liquid morphine and concentration is 50/100mL or less, but morphine will NEVER be schedule 5 |
| How often must DEA dispenser registrations generally be renewed? | every 3 years |
| For a pharmacy or hospital, what does the second letter of the DEA registration number generally correspond to? | The first letter of the pharmacy or hospital name. |
| Which nonphysician practitioners may be independently DEA registered if permitted under state law? | Practitioners such as dentists, veterinarians, podiatrists, and other authorized practitioners. |
| Does importing or exporting CS require DEA registration? | Yes, anyone who makes, prescribes, dispenses, distributes/ships, or researches controlled substances must register |
| : What basic checksum process can be used to verify the mathematical validity of a DEA registration number? | Add the 1st, 3rd, and 5th digits; add the 2nd, 4th, and 6th digits and multiply that sum by 2; add the two totals; the last digit of that total must equal the last digit of the DEA number. |
| Is separate DEA registration generally required for each pharmacy location? | Yes and for each location that it operates in |
| Does an individual practitioner necessarily need separate DEA registration for every practice location if controlled substances are only prescribed at those locations and not stored there? | Not necessarily |
| Which DEA form is generally used for dispenser registrations such as pharmacies, hospitals/clinics, practitioners, and mid-level practitioners? | DEA Form 224 for initial, and 224a for renewals |
| Which DEA form is associated with manufacturers, distributors, researchers, analytical laboratories, importers, and exporters? | DEA form 225 |
| Which DEA form is associated with narcotic treatment facilities? | DEA form 363 |
| Is the DEA registration considered expired while a timely renewal application is pending? | No |
| For how long after expiration may DEA permit reinstatement of an expired registration? | One calendar month. If missed, you need a new DEA registration application |
| Does every employee of a DEA-registered pharmacy need an individual DEA registration? | No, pharmacists usually operate under the location's DEA number |
| May an employed practitioner sometimes administer, dispense, or prescribe controlled substances under the DEA registration of the hospital or institution where they work? | Yes |
| What must the hospital assign to practitioners using the hospital’s DEA registration under this arrangement of providers operating under hosptial DEA#? | Must have a specific internal code |
| Must the hospital maintain a list linking practitioners to their internal controlled-substance codes? | Yes |
| For practictioners writing under the hosptial's DEA, can they write outgoing scripts for other pharmacies? | Yes |
| Can a new pharmacy owner automatically continue using the previous owner’s DEA registration indefinitely? | No, the new owner must apply for registration and state license |
| Can the previous pharmacy owner authorize the new owner to temporarily continue controlled-substance activities under the prior registration while the new DEA application is pending? | Yes, but the old owner is liable for violations and this temporary arrangements only lasts up to 45 days after purchase |
| When is a DEA Form 222 needed by law? | For ordering C2s at each transaction for up to 20 C2 medications per form |
| How many order lines does a DEA Form 222 contain according to Dr. C? | 20. If pharmacy needs to order more than 20 different C2 medications, it must complete another Form 222 for every 20 line items |
| What identifying information about the supplier must appear on DEA Form 222? | The supplier’s name and address + purchaser's DEA registration + signature |
| May a DEA registrant authorize another person to execute DEA Form 222 orders? | Yes, via power of attorney, however this doesnt need to be sent to the DEA along with the form |
| Where must the DEA Form 222 power-of-attorney documentation be maintained? | At regiestered location with controlled-susbtance records |
| If the supplier refuses an order for reasons other than a defective form, what should occur? | The supplier returns the order and provides a statement explaining the reason. |
| What information does the supplier record when filling a Schedule II order? | quantity supplied for each ordered item and the date the product was shipped. |
| When the purchaser receives a Schedule II shipment, what must it document? | The number of containers actually received and the date each item was received. Pharmacist must also verify quantity received |
| Does Texas require the receiving pharmacist to record initials and the actual date of receipt on the supplier invoice? | Yes. |
| What must a purchaser do if a completed DEA Form 222 is lost or stolen before the supplier fills it? | Prepare another Form 222 and include a statement identifying the serial number/date of the lost form and stating that the original order was not received. |
| If the original lost Form 222 is later found, may it simply be used? | No; it must not be filled as though it were a new valid order. |
| Can a supplier do a partial fill of an order on a 222? | Yes, but the remainder must be filled within 60 days |
| What happens if the remaining balance of a Form 222 order is not supplied within 60 days? | The outstanding portion can no longer be filled under that order |
| Are most suppliers required to report certain Schedule II and selected Schedule III/IV transactions through ARCOS? | Yes |
| What is the rule for transfer C2s between pharmcies? | Cant be more than 5% of total C2 quantity dispenses of that pharmacy for the calender year. This is calculated by doses (tablets, capsules, teaspoons, etc) |
| What does CSOS stand for? What is it for? | Electronic ordering of controlled substances, including electronic Schedule II orders. |
| Must a pharmacy designate a CSOS Coordinator? | Yes. |
| What is the CSOS Coordinator responsible for? | Managing issues related to issuance, revocation, and changes to digital certificates issued under the pharmacy’s DEA registration. |
| How long is a CSOS certificate valid for normally? | Until expiration of the associated DEA registration, generally up to 3 years. |
| What is a CSOS Signing Certificate used for? | Signing controlled substance orders |
| What additional authority is required for a CSOS Coordinator to obtain a signing certificate? | Appropriate authority such as being the registrant or holding a valid power of attorney. |
| Which drugs can must be ordered with their own separate form 222? | Carfentanil, etorphine or diprenorphine (aka animal opioids) |
| How would an organization order schedule 1 substances for authorized research purposes? | Using a form 222 |
| Does the purchasing party on a form 222 need to keep a copy of the form? | Yes |
| How often is DEA renewal required? | Every 3 years |
| How often is Federal inventory required for controls? | every 2 years, but texas is every year |
| Which form is filed for lost or stolen controls? What is the timline for reporting? | 106, submit within 45 days, must report to DEA within 1 day of discovery. Also notify TSBP |
| Which form is filed for less or theft of Listed chemicals (like psuedophed)? | Form 107, must report to DEA at earliest practical opportunity and file 107 within 15 days |
| What is required for the breakage or spillage of controls? | Its considered destruction, not loss, so it requires a form 41. If it is recoverable, file a form 41. If the medication is lost (non able to be recovered), file a 106 with 2 witnesses signing |
| Do returns of controls from pharmacy to supplier count toward the 5% rule? | no |
| Is form 222 needed for transfers of C2? | yes |
| Do C2s or other controls need to be locked up in a safe/locked cabnet under texas/federal law? | No, they may be dispersed among the non-controls |
| Does every tiny inventory discrepancy automatically require theft/significant-loss reporting? | No, only significant loss or theft |
| What information must DEA Form 106 generally contain? | Registrant information, DEA number, date/type of theft or loss, quantities lost, controlled substances involved, and related information. |
| Can a retail pharmacy become an Authorized Collector of controlled substances from ultimate users? | Yes, by modifying its DEA registration as required. |
| May a collection receptacle be placed in the patient waiting area with no employee monitoring? | No, must be properly secured and locked and a unique tracking number |
| What does texas law say about partial fills on C2s? | If its caused by stock shortage, the remaining can be filled within 72 hours If it is simply patient/provider request to fill partial, then you have 30 days from the date the script was written to fill the remaining C2 script |
| Do C2s require exact inventory counts? | Yes |
| Can Schedule III–V controlled substances generally be estimated during inventory? | Yes, unless the container contains more than 1,000 tablets or capsules. |
| Does Texas generally require a perpetual inventory of every controlled substance in every retail pharmacy? | No |
| Which Texas facility categories does Dr. C identify as requiring perpetual controlled-substance inventories? | Certain institutional, remote, ambulatory surgical center, freestanding emergency medical care, and similar facility categories specified by TSBP. |
| How long must controlled-substance records generally be retained under both federal and Texas law according to Dr. C? | 2 years, and must be readily retrievable and seperate from ordinary records (so separate the non-controls, C3-5, and C2s |
| The 3-file system for records applies strictly to which types of scripts? | Verbals and physical scripts, not always required for electronic |
| Give examples of controlled-substance prescription red flags listed by Dr. C.? | Lots of people w/same script from same Dr, unusual quantities, long distance travel, multiple opioids together, cash pay, cocktails, pattern prescribing, weird dosing, early fills/refills, |
| Which practitioners does Dr. C identify as authorized to prescribe controlled substances in Texas when otherwise properly licensed and authorized? | Physicians, dentists, podiatrists, veterinarians, therapeutic optometrists/optometric glaucoma specialists, and appropriately authorized APRNs and physician assistants. |
| May an authorized agent communicate a Schedule III–V controlled-substance prescription to a pharmacy on behalf of a prescriber? | Yes, but the agent must have a formal/written appointment by the prescriber |
| May a prescriber’s employee or other designated agent ordinarily verbally communicate an emergency Schedule II prescription to a pharmacy? | No; the book notes that the prescriber must personally communicate an emergency Schedule II prescription for verbals |
| General quantitiy limit for acute opioid script in texas? | 10 days, even if its a C3-5 |
| When does the 10 day acute limit not apply? | For hospice/palliative care, cancer, chronic pain/conditions, or for SUD |
| May a pharmacist correct a missing patient address or obvious misspelling of the name using professional judgment without contacting the prescriber? | Yes |
| Which pharmacies must maintain perpetual inventory of ALL controls? (C2-5) | Class C ambulatory surgery centers, controls stored at a remote lcoation, class F pharmacies **Class C institutional pharmacies (like hosptials or inpatien psych facilities) only require perpetual C2 inventory (not C3-5 perpetual) |
| Which elements of a script can a pharmacist NOT change for a control? | Patient name, drug, provider, date issued, unless an obvious/limited error situations, otherwise a new script is needed |
| Is a mid-level provider ever allowed to write a C2 script if they are outside texas? | NEVER, must be a MD/DO to be valid under an approved plan |
| What are the rules for verbal C2s? | Only in emergencies, and must follow-up with valid written/electronic script within 7 days |
| What are the rules for verbal C3-5s? | In texas, the 7 day rule still applies, even tho it is not required federally |
| Does the EPCS require providers to use 2 factor authentication? | Yes, and must be backed up and audited daily |
| Can electronic script records be kept non-electronically? | No, there needs to be an electronic record |
| What patient information must be written on a control script? | Full name, address, and DOB (or age) |
| What provider info is needed on controlled scripts? | Providers name, phone #, and address of clinic location where the script was issued from |
| In texas, can a mid-level provider call in a verbal C2, even in an emergency? | No, only MD/DO/DDS, vets, and podiatrists |
| What federal law addresses prescribing controlled substances through the internet or telemedicine? | Ryan Haight Act |
| What special telemedicine rule does Dr. C describe for buprenorphine products? | DEA issued a rule allowing certain buprenorphine prescribing through audio-only or audiovisual telemedicine encounters subject to conditions. But must check PMP, if no PMP data exists, 7 days max |
| May an original electronic controlled-substance prescription generally be transferred between pharmacies for initial filling? | Yes, but no for initial fills of non-electronic scripts |
| Can retail pharmacies transfer C2 scripts, what about initial fills? | Yes, but only one time, for paper scripts, the paper could be handed back to the patient to take elsewhere |
| What information must be documented for transfered controls? | DEA number of sending pharmacy, name of transfering pharmacist, and date of transfer, and name of recieving pharmacist |
| How long do transfer records need to be kept? | 2 years for electronic controls |
| Must both pharmacies in a control transfer have compatible electronic systems to transfer an electronic control script? | Yes, they cannot use an intermediary system to covert it into another form |
| Does a prescriber need to use Official Prescription Form for written C2s? | Yes, unless exception applies |
| When is day 0 for a C2 script? | The written date or the earliest fill date |
| Max supply for a C2 script(s)? | 90 days, even if broken up into multiple future fill scripts |
| Can C2 scripts be faxed? | Usually no Some exceptions for compounded narcotic Schedule II products for DIRECT administration, Schedule II prescriptions for LTCF residents, and Schedule II narcotic prescriptions for qualifying hospice patients. |
| Is an emergency Schedule II quantity automatically limited to a fixed 72-hour or 7-day supply? | No. The quantity is limited to what is necessary during the emergency period. |
| By when must the remainder of an emergency verbal Schedule II prescription be dispensed? | Within 72 hours, otherwise pharmacist needs to notify provider |
| May a caregiver request a Schedule II partial fill for an adult patient? | Generally no, unless the caregiver has applicable legal authority such as power of attorney. |
| Who may request a partial fill for a minor patient? | Parent or legal guardian |
| How long may Schedule II prescriptions for LTCF or terminally ill patients generally be partially filled under the rule described by Dr. C? | 60 days |
| Are hospital inpatient medication orders exempt from the Texas Official Prescription Form requirement? | Yes |
| What are the rules for transfering C3-5? | Only 1 time and must be for a refill, if it is an initial fill, transfers are only allowed if the script is electronic |
| What maximum hospital-discharge quantity does Dr. C state for the Schedule II Official Prescription Form exception? | 7 days supply, must be dispensed by the hospital pharmacy |
| Who is exempt from the Official Prescription Form rule for C2s? | Hosptial inpatient emergency dispensed by hospital Prison inmates Animals in approved hosptials/parks therapeutic optometrist Out of state practitioners |
| Does texas/federal law address automatic control refills? | Only allows auto refills on C4 and C5 |
| When does texas require lock boxes or safes for storage of C2s? | Class C institutional pharmacies Class C Ambulatory Surgical Center pharmacies Class F Freestanding Emergency Medical Care Facility pharmacies |
| What three prescription files does Texas require for paper controlled-substance/noncontrolled prescription storage according to Dr. C? | File 1 Schedule II; File 2 Schedule III–V; File 3 dangerous drugs and OTC drugs dispensed pursuant to prescription. |
| What is required for pharmacists with invoices of controls recieved by pharmacy? | Pharmacist must initial and date of receipt |
| Are verbal C3-5 scripts generally ok in texas? | Yes |
| For what drug classes is the PMP check specifically mandatory | Opioids, benzodiazepines, barbiturates, and carisoprodol. |
| : Is the PMP check required when the patient has been diagnosed with cancer or sickle cell disease? | No |
| What are the daily and 30-day limit for pseudoephedrine? | 3.6 grams per day, 9 grams/30 days |
| What special 30-day limit applies to pseudoephedrine products purchased by mail-order customers according to Dr. C? | 7.5g/30 days |
| Texas minimum age for Pseudophed purchase? | 16 years old |
| Which controlled-substance records must remain at the registered pharmacy rather than being moved to a DEA-approved central recordkeeping location? | Executed DEA Form 222 records, controlled-substance inventories, and controlled-substance prescription records must remain at the pharmacy. The central-recordkeeping exception applies to certain shipping and financial records. |
| What controlled-substance records may be maintained at a central location after notice to DEA? | Certain shipping and financial records may be kept at a central location. The pharmacy must notify the nearest DEA Diversion Field Office, and unless DEA denies the request, central recordkeeping may begin 14 days after DEA receives the notice. |
| Can a pharmacy keep executed DEA Form 222s at its corporate central recordkeeping facility instead of the registered pharmacy? | No. Executed DEA Form 222 records must remain at the registered pharmacy and be readily retrievable there. |
| When does Texas's physical three-file prescription system NOT have to be used? | When the prescription records are maintained electronically in a compliant system. Electronically maintained prescriptions do not have to be physically placed into the three-file paper system. |
| If controlled-substance prescription records are electronic, can they be physically stored on a server at another location? | Yes, provided the electronic records remain readily retrievable at the registered pharmacy for inspection. Dr. C distinguishes this from sending required physical onsite records to a central recordkeeping facility. |
Created by:
cdaughtry