Chapter B Controlled Substance Laws and Regulations PDF

Chapter B Controlled Substance Laws and Regulations Copyright © 2024 Gary Cacciatore History and Federal vs. State Law B.1-2 2 ◈ Federal Controlled Substances Act ⬩ 1970 law enforced by the DEA, part of Department of Justice ◈ Federal vs. State Controls ⬩ The more stringent (strict) law must be foll...

Chapter B Controlled Substance Laws and Regulations Copyright © 2024 Gary Cacciatore History and Federal vs. State Law B.1-2 2 ◈ Federal Controlled Substances Act ⬩ 1970 law enforced by the DEA, part of Department of Justice ◈ Federal vs. State Controls ⬩ The more stringent (strict) law must be followed. ⬩ If two laws completely contradict each other where one can’t be followed without violating the other (this is rare), the state law must yield to the federal law. ⬩ Marijuana Copyright © 2024 Gary Cacciatore Enforcement B.2 3 ◈ Enforcement ⬩ FCSA – Drug Enforcement Administration (DEA) ⬩ TCSA – Department of Public Safety (DPS) and Texas State Board of Pharmacy (TSBP) ⬩ Shared Responsibility ⬩ Texas State Board of Pharmacy enforces certain provisions of the TCSA regarding pharmacists and pharmacies and is responsible for the prescription drug monitoring program (PMP). Copyright © 2024 Gary Cacciatore Drug Classification B.3-4 4 ◈ Schedule I ⬩ No accepted medical use ◈ Schedule II ⬩ Highest abuse potential ◈ Schedule III ◈ Schedule IV ◈ Schedule V ◈ Exempted products (Example – Fioricet ) ⬩ DEA Proposed rule would eliminate all Butalbital products from exempt list. See Supplement ◈ Listed Chemicals Copyright © 2024 Gary Cacciatore Scheduling of Controlled Substances B.4 5 ◈ Scheduling ⬩ Federal – U.S. Attorney General (but must get scientific and medical opinion from FDA/HHS) ⬩ e.g. Rescheduling of hydrocodone combination products ⬩ Texas – Commissioner of Texas Department of State Health Services Copyright © 2024 Gary Cacciatore Schedule of Compounded Controlled Substances B.4-6 6 ◈ DEA 20% rule (for solutions and solid dosage forms) ◈ Some CIIs will remain a CII regardless of concentration. ◈ Codeine (all codeine products require Rx in TX) ⬩ CV limit – 200mg/100ml ⬩ CIII limit – 1800mg/100ml ◈ Opium ⬩ CV limit – 100mg/100ml ⬩ Note: Texas limit – 50mg/100ml ⬩ CIII limit – 500mg/100ml Copyright © 2024 Gary Cacciatore Registration (cont.) B.6 7 ◈ Classification of Registrants ⬩ Manufacturers, dispensers, distributors, importers, exporters, researchers, narcotic treatment programs, etc. ⬩ New proposed registration for emergency medical services agencies Copyright © 2024 Gary Cacciatore 8 Registration B.6-7 ◈ Closed System of Distribution ⬩ All participants must be registered unless exemption applies. ◈ Classification of Registration (by activity) ⬩ Dispensers (includes prescribers) ⬩ Registration starts with A, B, or F (or G for DOD contractors) ⬩ Independent prescribers (physicians, dentists, etc.), hospitals, and pharmacies ⬩ Midlevel practitioners ⬩ Registration starts with M ⬩ Physician assistants, advanced practice registered nurses, etc. Copyright © 2024 Gary Cacciatore Registration (cont.) B.7-8 9 ◈ Separate registration needed for separate locations if controlled substances are stored at the location. ◈ Confirmation of DEA number ◈ Exemptions ⬩ Agents or employees of registrants ⬩ Interns and Residents ⬩ Federal practitioners, TSBP employees, etc. Copyright © 2024 Gary Cacciatore Registration (cont.) B.8-10 10 ◈ Application ⬩ DEA Form 224 (for dispensers) ⬩ Some DEA offices now conduct pre-registration inspections. ◈ Renewal (for dispensers) – Every 3 years ◈ Grounds for Denial ◈ Termination of Registration Copyright © 2024 Gary Cacciatore Registration (cont.) B.10 11 ◈ Temporary Use of DEA Registration ⬩ Used for Sale of Pharmacy ⬩ Allows new owner to use previous owner’s DEA registration using a Power of Attorney ⬩ Usually not for more than 45 days Copyright © 2024 Gary Cacciatore Ordering Schedule II Drugs 12 B.10-12 ◈ Controlled Substance Ordering System (CSOS) ⬩ Electronic ordering system for Schedule II drugs ⬩ Not required, can still order with manually with paper forms ⬩ CSOS certificates issued to individuals ◈ DEA Form 222 ⬩ Manual ordering system for Schedule II drugs ⬩ Person who orders and receives the Schedule II must issue the DEA Form 222. Copyright © 2024 Gary Cacciatore Ordering Schedule II Drugs – DEA Form 222 (cont.) B.11-12 13 ◈ Power of Attorney (POA) allows other individuals to sign DEA Form 222. ◈ Power of Attorney may be issued to any individual in the pharmacy. Does not have to be a pharmacist. ◈ POA must be signed by the registrant. ◈ POA may be revoked at anytime. Copyright © 2024 Gary Cacciatore Ordering CII Drugs – DEA Form 222 (cont.) B.13-14 14 ◈ DEA Form 222 ⬩ Must be signed by the registrant (Individual, Partner, or Corporate Officer) or person with Power of Attorney. ⬩ Purchaser must make a copy of form. ⬩ Supplier reports transaction (products distributed) to DEA as part of ARCOS reporting. ⬩ If supplier does not report to ARCOS, they must send copy of Form 222 to DEA by mail or email. ⬩ Purchaser records quantity received and date on copy of form. Copyright © 2024 Gary Cacciatore DEA Form 222 (cont.) B.13-14 15 ◈ Alterations, erasures, or changes not accepted ◈ Errors in filling out form will result in form not being accepted. ◈ If partial quantity is supplied, remainder must be supplied within 60 days. ◈ Lost or stolen forms Copyright © 2024 Gary Cacciatore Ordering CIII-CV Controlled Substances B.14-15 16 ◈ No special DEA Form ◈ Records must be “readily retrievable”. ◈ Invoice required – must contain: ⬩ Name of controlled substance ⬩ Dosage form and strength ⬩ Number of units per container (100 tablet bottle) ⬩ Quantity received (containers) ⬩ Date of receipt ⬩ Name, address, and DEA number of registrant from which CS was received Copyright © 2024 Gary Cacciatore Distributions of Controlled Substances B.15 17 ◈ Pharmacies may conduct limited transfers of CS (distributions as opposed to dispensing) without having to be registered as a distributor with DEA. ◈ Transfers (distributions) must be to another DEA registrant (i.e. registrant to registrant). ◈ The 5% rule ⬩ Pharmacies may distribute CS to another registrant without being registered as a distributor if the total dosage units of CS distributed does not exceed 5% of the total dosage units dispensed and distributed. Copyright © 2024 Gary Cacciatore Transfers of Controlled Substances (cont.) B.15-17 18 ◈ Records required – DEA Form 222 or invoice ◈ Transfer upon sale of a pharmacy ⬩ Allows transfer to new owner without regard to the 5% rule ◈ Distributions to ambulances or EMS units ⬩ Hospitals may provide CS for restocking if specific requirements are met. ⬩ New rules from DEA are pending on this. ◈ Return of controlled substances Copyright © 2024 Gary Cacciatore Storage and Security B.17 19 ◈ Locked cabinet; or ◈ Dispersed through noncontrolled inventory ⬩ Although not many pharmacies do this for Schedule II drugs, it is important to know that it meets DEA rules. ◈ Cannot store all controlled substances together on one unsecured shelf in pharmacy ◈ Hospitals and Class F pharmacies in Texas must have Schedule II controlled substances in locked cabinet. Copyright © 2024 Gary Cacciatore Theft or Significant Loss B.17-18 20 ◈ Initial notice to DEA required within one business day ◈ DEA Form 106 must be filled out online to DEA Theft and Loss Reporting (TLR) system. Copy must be sent to: ⬩ TSBP ⬩ Local police (recommended by DEA) ◈ DEA Form 106 must be filled out within 45 days of discovery. ◈ Breakage or spillage is not considered a loss. ◈ Theft or loss of list chemicals - DEA Form 107 (within 15 days). Copyright © 2024 Gary Cacciatore Miscellaneous DEA Rules and Policies B.18-20 21 ◈ Convicted Felon Rule ⬩ Registrant (pharmacy) may not employ felons unless granted DEA waiver. ◈ Patients Bringing Controlled Substances to Hospital ◈ Employee Screening Procedures ⬩ Background checks and screening questions ◈ Responsibility to Report Diversion ⬩ Employee must report to employer, not to DEA. ⬩ Employer (registrant) must report to DEA under theft/loss rule. Copyright © 2024 Gary Cacciatore Disposal and Destruction of Controlled Substances B.20-23 22 ◈ Disposal of Stock Controlled Substances ⬩ On-site destruction ⬩ Requires DEA Form 41 ⬩ Not done frequently in most practices ⬩ DEA Form 41 is also used to document destruction of dispensed controlled substances a pharmacy receives as an authorized collector. ⬩ Delivery to DEA Registered Reverse Distributor ⬩ Preferred method for destruction of stock drugs ⬩ Treated as transfer with invoice or DEA Form 222 Copyright © 2024 Gary Cacciatore Disposal and Destruction of Controlled Substances (cont.) B.23-24 23 ◈ Disposal of CS from Ultimate Users ⬩ Authorized Collectors – voluntary ⬩ Mail-back programs ⬩ Collection events – law enforcement only ◈ Disposal of CS for hospice patients by hospice employees ⬩ Still waiting for DEA rules on this ◈ Waste of CS ⬩ When wasting a partial quantity of a CS in a hospital, the DEA disposal rules do not apply. ⬩ Texas rules requires a witness to waste CS however. Copyright © 2024 Gary Cacciatore Inspections B.24-25 24 ◈ Items DEA cannot inspect (without consent of registrant) ⬩ Financial data ⬩ Sales data ⬩ Pricing data Copyright © 2024 Gary Cacciatore Records/Inventories B.25 25 ◈ Biennial inventory– every 2 years ⬩ Note: TSBP requires annual CS inventory ◈ Newly scheduled drugs on day scheduled ◈ All drugs “on hand” Copyright © 2024 Gary Cacciatore Records/Inventories (cont.) B.25 26 ◈ Counts ⬩ Exact for CII ⬩ Estimated for CIII-CV if fewer than 1000 ◈ Inventory format ◈ Texas has additional inventory requirements ⬩ Signed and notarized by PIC ⬩ Perpetual inventories Copyright © 2024 Gary Cacciatore Records (cont.) B.25-26 27 ◈ Records of Receipt of Controlled Substances ⬩ CII – DEA Form 222 (copy 3) ⬩ CIII-V – invoice ◈ Prescription files ⬩ Texas requires a 3-file system. ◈ Medication records—inpatient Copyright © 2024 Gary Cacciatore Central Recordkeeping and Computerization B.26-27 28 ◈ For invoices and financial data ◈ Notification to DEA ◈ Records stored centrally cannot include: ⬩ Executed DEA order forms ⬩ Inventories ◈ Computerization of prescription information Copyright © 2024 Gary Cacciatore Controlled Substance Prescriptions 29 B.27-28 ◈ Who can prescribe? ⬩ Determined by state law ◈ Designated agent ⬩ May communicate Rx ⬩ If not an employee of prescriber (e.g. LTCF nurse), agency agreement should be in writing between LTCF nurse and practitioner. Copyright © 2024 Gary Cacciatore Mandatory Electronic Controlled Substance Prescriptions 30 B.28-29 ◈ Since January 1, 2021 all CS prescriptions in Texas must be issued electronically unless an exception applies. ◈ Exceptions ⬩ Include veterinarians, prescribers who obtain waiver, temporary technical issues, etc. ⬩ If an exception applies, the prescription may be issued in writing (not verbally, phoned or faxed). ◈ A pharmacist that receives a CS prescription that is not electronic is NOT required to verify an exception applies. Copyright © 2024 Gary Cacciatore Emergency Verbal Prescriptions for Controlled Substances B.29 31 ◈ Verbal orders for all controlled substances are only valid in an emergency under Texas law. ◈ This is different than federal law which allows verbal orders for controlled substances in Schedules III-V. ◈ Within 7 days of authorizing an emergency verbal prescription for a controlled substance, the practitioner must provide the pharmacy an electronic prescription. See note in book. ◈ TSBP does not require pharmacists to determine an emergency exists if they receive a verbal CS prescription. Copyright © 2024 Gary Cacciatore Controlled Substance Prescriptions (cont.) B.29-30 32 ◈ Written Prescription Requirements ⬩ Because of many exceptions to mandatory electronic, you must know these requirements. ⬩ Must be signed and dated on the date issued ◈ Changing Information on written CS Rx ⬩ In 2022, DEA announced intention to write new regulations on this. ⬩ Current guidance from Board of Pharmacy. Page B.30 Copyright © 2024 Gary Cacciatore Controlled Substance Prescriptions (cont.) B.30 33 ◈ Pharmacist Preparation of Prescription for Practitioner’s Signature ⬩ DEA does not allow pharmacists to prepopulate a CS prescription and send it to a practitioner (e.g. via Fax) for signature. Copyright © 2024 Gary Cacciatore Controlled Substance Prescriptions (cont.) B.30-32 34 ◈ Oral (verbal) ⬩ Not valid for CS unless it is an emergency ⬩ This is different than federal law that allows verbal orders for Schedule III-V prescriptions. ◈ Electronic (computer to computer) ⬩ Requires certification of both prescriber and pharmacy’s computer system ⬩ Mandatory in Texas unless an exception applies Copyright © 2024 Gary Cacciatore Corresponding Responsibility and Red Flags B.32-34 35 ◈ To be valid, CS Rx must be issued for a legitimate medical purpose in the usual course of professional practice. ◈ Pharmacist has “corresponding responsibility” to ensure Rx is valid and must be on alert for “red flags.” Copyright © 2024 Gary Cacciatore Corresponding Responsibility and Red Flags (cont.) B.33-34 36 ◈ Red flags are reasons to question a prescription, not an absolute indication Rx is invalid. ⬩ Use professional judgment when dispensing pain medication. ⬩ Avoid denying legitimate patients their pain medication. ◈ See also Red Flags Rule 291.29 in Chapter E. ◈ Practitioner self-prescribing and prescribing CS for family members Copyright © 2024 Gary Cacciatore Ryan Haight Act/Internet Prescribing/Telemedicine 37 B.34-35 ◈ Intended to address internet-based prescribing of CS ◈ Defines valid prescription as requiring at least one in- person medical evaluation of patient ◈ Exception for “covering physicians” and telemedicine ⬩ DEA is required to issue new registration for telemedicine practitioners. (This hasn’t happened despite 15 years since law passed) ◈ Telemedicine prescribing of CS ⬩ DEA proposed rule Copyright © 2024 Gary Cacciatore Dispensing CS in Texas B.35 38 ◈ Delivery ⬩ Doesn’t really require identification – See note on p. B.35. ◈ Out-of-State CS Prescriptions ⬩ Schedule II – Can’t generally fill from out-of-state prescriber unless pharmacy has a plan approved by TSBP ⬩ Schedule III-V – May fill from out-of-state prescriber (except for out-of-state nurse practitioners and physician assistants) Copyright © 2024 Gary Cacciatore Schedule II Prescriptions 39 B.36 ◈ Written Schedule II Prescriptions ⬩ If one of exceptions to mandatory electronic prescription requirement applies, a CII prescription can be issued in writing. ⬩ A written CII prescription must be on Texas Official Prescription Form. ◈ Faxed Schedule II Prescriptions ⬩ DEA allows facsimile prescriptions to be used as an original written Rx for injectable CII narcotics, any CII for LTCF patients, and CII narcotics for hospice patients. ⬩ TCSA does not address, this but TSBP has indicated pharmacists may follow the federal law. Copyright © 2024 Gary Cacciatore Schedule II Prescriptions (cont.) B.36-37 40 ◈ Electronic Schedule II Prescriptions ⬩ Now required in Texas unless an exception applies ◈ Emergency dispensing (from verbal Rx) ⬩ Limited to the amount needed to treat the patient during emergency ⬩ Communication must be from prescriber, not an agent of the prescriber (despite Texas law) ⬩ Pharmacy must receive an electronic Rx within 7 days Copyright © 2024 Gary Cacciatore Schedule II Prescriptions (cont.) B.37 41 ◈ Multiple CII Rxs ⬩ No refills of CIIs, but a practitioner may issue multiple CII Rxs to be filled at a later date (do not fill until _____) ⬩ Not more than 90-day supply (total) Copyright © 2024 Gary Cacciatore Schedule II Prescriptions (cont.) B.37-39 42 ◈ Partial filling/dispensing of CII Rx ⬩ “Unable to supply” – Remainder must be provided within 72 hours ⬩ Patient or prescriber request – Partial fills may be provided for up to 30 days ⬩ LTCF or terminally ill patient – May partially fill for up to 60 days Copyright © 2024 Gary Cacciatore Schedule II Prescriptions (cont.) B.39 43 ◈ Transfer of Original Schedule II Rx for Initial Filling ⬩ Only permitted for electronic prescriptions. ⬩ Despite DEA permitting this many pharmacy systems are unable to do this. Copyright © 2024 Gary Cacciatore Schedule II Prescriptions (cont.) B.39-40 44 ◈ Time limit ⬩ Federal law – not addressed ⬩ Texas law - requires CII Rxs to be filled within 30 days after the date the Rx is issued (or first date authorized). ◈ Quantity limits ⬩ No legal limit for a single prescription for most CS ⬩ Pharmacists must exercise corresponding responsibility. ⬩ Insurance coverage may limit quantities. ⬩ 90-day supply limit when multiple CII Rxs issued at same time ⬩ Texas law limits prescriptions for opioid drugs (including CII opioids) for “acute pain” to 10-day supply. ◈ Treatment of pain and pain clinic certification Copyright © 2024 Gary Cacciatore Schedule II Prescriptions (cont.) B.40 45 ◈ Required Notification on Safe Disposal of Schedule II Controlled Substances ⬩ Unless exemption applies, pharmacies must provide patients a notification on locations for the safe disposal of Schedule II controlled substances or an Internet address that provides a searchable database of disposal locations. Copyright © 2024 Gary Cacciatore Texas Official Prescription Form B.40-43 46 ◈ Issued by TSBP and required for written Schedule IIs ◈ Pharmacist’s Responsibilities – p. B.42 ◈ One Rx Per Form ⬩ What to do if non-CII written on official form ◈ Exceptions to use of Official Prescription Form – p. B.42-43 Copyright © 2024 Gary Cacciatore Schedule III-V Prescriptions B.43-44 47 ◈ Must be issued electronically unless exception applies ◈ If exception applies, may be issued in writing ◈ In emergency, may be issued verbally (or faxed) ⬩ Within 7 days of issuing an emergency CS Rx, prescriber must provide ◈ ◈ an electronic Rx to pharmacy Refills ⬩ Up to 5 times or 6 months (includes C-V in Texas) ⬩ Partial filling is not a refill Transfers ⬩ One time only; if pharmacies share common database, Rxs may be transferred up to 5 times within 6 months to all pharmacies in system. ⬩ Prescriptions received but not filled ⬩ Transfers of original Rx – permitted for electronic Rx only Copyright © 2024 Gary Cacciatore Texas Prescription Monitoring Program (PMP) for Controlled Substances B.45-47 48 ◈ Mandatory use ⬩ Checking the PMP is mandatory for practitioners (except vets) when prescribing and pharmacists when dispensing for opioids, benzodiazepines, barbiturates, and carisoprodol. ⬩ Must check full report, not just patient score. See Note page B.46 ⬩ Exceptions for patients with cancer, sickle cell disease, or in hospice ⬩ PMP check may be integrated into pharmacy management system. ◈ Access to PMP is restricted. Copyright © 2024 Gary Cacciatore Texas Prescription Monitoring Program (PMP) for Controlled Substances B.47 49 ◈ PMP system sends electronic notifications of potentially prescribing patterns. ◈ Electronic reporting/transmission of all CS Rxs dispensed ⬩ Data must be submitted to TSBP via the PMP program no later than the next business day after the Rx is completely filled. ⬩ Must send zero report if no controlled substances dispensed for 7 consecutive days Copyright © 2024 Gary Cacciatore Methadone and Treatment of Narcotic Dependence 50 B.47-49 ◈ Methadone may only be prescribed and dispensed for analgesic purposes (unless registered as Narcotic Treatment Facility). ◈ Office-Based Treatment of Opiate Dependence ⬩ Subutex (buprenorphine) and Suboxone (buprenorphine/naloxone) are the only narcotics that may be prescribed to treat opioid dependence. ⬩ An “X” number is no longer required. ⬩ Pharmacists may fill prescriptions for these drugs if prescribed to treat opioid dependence, but cannot fill a prescription for methadone prescribed for that purpose. Copyright © 2024 Gary Cacciatore Methamphetamine Controls B.49-51 51 ◈ ◈ ◈ ◈ Primarily pseudoephedrine products Age restriction; Texas Display restrictions Sales limits (federal law stricter) ⬩ 3.6 g base product per day ⬩ For pseudoephedrine HCL 3.6 g base = 146 30mg tablets ⬩ 9 g base product per 30 days ◈ Logbook requirements ◈ Real-time electronic logging system with other states is in effect. ◈ Training and self-certification Copyright © 2024 Gary Cacciatore