Texas Pharmacy Law Cheat Sheet

Behind the Counter Can Legend Drugs (e.g. Codeine, Opium Tinctures) Be Dispensed Without Prescription? Which Ones? Logging Requirements? Which Drugs Are Required to Be Behind the Counter? Dispensing Requirements (Maximum Allowed/Logging)? Opium Tinctures (no more than 15 mg opium per 29.57 ml). Must...

Behind the Counter Can Legend Drugs (e.g. Codeine, Opium Tinctures) Be Dispensed Without Prescription? Which Ones? Logging Requirements? Which Drugs Are Required to Be Behind the Counter? Dispensing Requirements (Maximum Allowed/Logging)? Opium Tinctures (no more than 15 mg opium per 29.57 ml). Must meet the following conditions Dispensed only by a pharmacist No more than 240 ml (or 48 dosage units) in a 48 hour period Purchaser is at least 18 years old Record is kept in a bound book, and includes name and address of purchaser, quantity, date, and signature of dispensing pharmacist Follows federal law. Only pseudoephedrine is specifically named See above Can Syringes Be Dispensed Without Not Specified Prescription? Logging Requirement? What are the Rules Around Pseudoephedrine? Limits? Follows federal law Drug Administration Can Pharmacists Administer Yes – collaborative agreement with provider required. Immunizations? Which Ones Can Pharmacists can administer all vaccines in Texas They Administer? Can Pharmacists Administer Medications? Which Ones Can Pharmacists can prescribe, dispense and administer epinephrine and naloxone. They Administer? Is a Collaborative Practice Agreement/Other Required? See above Facility Requirements? Private Not specified Space/Partition? Other Requirements? Patient Age Limit? If administering to patient under 14 years of age, patient must have referral from a physician. However, influenza vaccine can be administered by pharmacists to a patient over 7 years of age without referral from a physician. Are There Laws/Protections for A pharmacist can administer epinephrine in good faith and not be liable for civil damages unless willfully or Emergencies (e.g. Anaphylaxis, wantonly negligent Overdose)? Drugs Covered? Pharmacists’ Rights Can Pharmacists Refuse to Fill a Pharmacist can refuse to fill if there are clinical or fraudulent concerns. In these cases, pharmacist has Valid Prescription (e.g. Birth Control, responsibility to contact prescriber for clarifications Narcotics)? In What Circumstances? Requirements for Refusal? Not specified Religious Objection? Not specified What Actions Can Be Taken Against No action specified for refusal to fill. Other Grounds for discipline for a pharmacist license can be found RPh License for Refusal to Fill? here. Appeals Process on Actions? See General Procedures in a Contested Case Emergency Refills? Pharmacist unable to contact prescribing practitioner. If a pharmacist is unable to contact the prescribing practitioner after a reasonable effort, a pharmacist may exercise his or her professional judgment in refilling a prescription drug order for a drug, other than a Schedule II controlled substance, without the authorization of the prescribing practitioner, provided: ○ failure to refill the prescription might result in an interruption of a therapeutic regimen or create patient suffering; ○ the quantity of prescription drug dispensed does not exceed a 72-hour supply; ○ the pharmacist informs the patient or the patient's agent at the time of dispensing that the refill is being provided without such authorization and that authorization of the practitioner is required for future refills; ○ the pharmacist informs the practitioner of the emergency refill at the earliest reasonable time; ○ the pharmacist maintains a record of the emergency refill containing the information required to be maintained on a prescription as specified in this subsection; ○ the pharmacist affixes a label to the dispensing container as specified in §291.33(c)(7) of this title (relating to Operational Standards); and ○ if the prescription was initially filled at another pharmacy, the pharmacist may exercise his or her professional judgment in refilling the prescription provided: the patient has the prescription container, label, receipt or other documentation from the other pharmacy that contains the essential information; © tl;dr pharmacy llc. All Rights Reserved after a reasonable effort, the pharmacist is unable to contact the other pharmacy to transfer the remaining prescription refills or there are no refills remaining on the prescription; the pharmacist, in his or her professional judgment, determines that such a request for an emergency refill is appropriate and meets the requirements of clause (i) of this subparagraph; and the pharmacist complies with the requirements of clauses (ii) - (vi) of this subparagraph. 22 TAC §291.34 Other Settings Long-Term Care Who Can Dispense/Administer Medication? Registered professional nurse, licensed vocational nurse, or an individual under direct delegation orders by a physician Who Can Access Dispensing Units? Special Requirements? Not specified Who Can Access Medications Without Pharmacy Staff? Only a designated licensed nurse or practitioner may remove such drugs and devices. Requirements on IV Labeling for Dispensing Unit Not specified Requirements on Unit Dose Labeling for Dispensing Unit Not specified Requirements on MultiDose/Repackaging Not specified Requirements on Storage of Controlled Medication? Not specified Who can Access Controlled Medications? Not specified Emergency Dispensing Requirements? Record Keeping Requirements? An official prescription form is not required in a long-term care facility (LTCF) if: (1) an individual administers the substance to an inpatient from the facility's medical emergency kit; (2) the individual administering the substance is an authorized practitioner or an agent acting under the practitioner's order; and (3) the facility maintains the proper records as required for an emergency medical kit in an LTCF. The person administering medications shall properly record the medications administered Nuclear RPh Special Requirements? Board certification required or 700 hours of training Nuclear Pharmacist to Technician ratio 1:6 Class-B Pharmacy, and is regulated by Radiation Control Program. Facility Special Requirements? Similar requirements to other Class-A pharmacies, but with additional equipment required to measure radioactivity Remote Special Licensure Requirements? Class A or Class C license if in state or Class E license if out of state Must Pharmacy Be Located at Dispensing Site? No, provided the dispensing site is within a certain mile radius of the provider pharmacy Telework? From Out of State? Yes Must Pharmacist Have an In-State Yes License? Central Fill Allowed? Yes Medical Offices Which Type of Providers Can Receive/Store Medications? Administer? Restrictions on Drug Samples? Not specified (Medical Offices are not under the jurisdiction of the Board of Pharmacy in the state of Texas) Not specified Can Prescribers Prepare/Dispense Prescriptions? Controlled? Sterile Yes Compounding? Requirements on Preparation/Storage/Logging? Not specified Drug Sources? Can Pharmacies Supply Offices? Not specified (Medical Offices are not under the jurisdiction of the Board of Pharmacy in the state of Texas) © tl;dr pharmacy llc. All Rights Reserved Miscellaneous Correctional Facilities Dispensing Official Texas Prescription Form (i.e. triplicate Rx pad) not required for CII if patient is currently incarcerated Rules in correctional facility operated by Texas Dept. of Criminal Justice Veterinary/Animal Dispensing Rules Triplicate not required for CII if “patient” resides in animal hospital, zoo, wildlife park, or exotic game ranch Emergency Room/Urgent Care Dispensing Rules During times when a pharmacist on duty, any dispensing must be done by a pharmacist. If a pharmacist is not on duty, only a 72-hour supply may be provided to the patient. Triplicate not required for a CII if: Individual administers the substance to an inpatient from emergency kit Other Facilities & Dispensing Rules Substance administered by authorized practitioner Proper records are maintained for emergency kit International Drug Sources Rules Not specified PBM Rules Not specified Records Patient Records Can Records be Held Digitally? Requirements for Printed Copy? Records can be held digitally provided a hard copy can be produced within 72 hours upon request Other Requirements? How Long do Controlled Prescriptions Need to Be Held? 2 years CII? CIII to V? How Long do Legend 2 years Prescriptions Need to Be Held? Who Can Request or Receive Records (Family, Others)? Any Patient or “Patient’s Agent.” Also, board of pharmacy and state/federal law enforcement agents. Restrictions? POA? Reporting Requirements for Drug Monitoring Programs? The next business day after dispensing a controlled substance, the pharmacy MUST electronically submit Rx information to the board. Errors must be electronically corrected within 7 business days. If a pharmacy does not dispense any controlled substance prescriptions, the pharmacy must electronically submit to the board a zero report indicating that no controlled substances were dispensed every seven days. Requirements for Reporting Suspected Fraud/Abuse? N/A Requirements for Reporting ADRs? N/A (unless required by a specific federal REMS program for certain drugs) Requirements for Reporting Licensure Violations? Anyone may file a complaint against a TSBP licensee; however, complaints must be received in writing. Requirements for Reporting Privacy Violations? N/A Patient Profile What Must RPh Review on Patient Profile Prior to Dispensing? REMS Requirements? (I) known allergies; (II) rational therapy-contraindications; (III) reasonable dose and route of administration; (IV) reasonable directions for use; (V) duplication of therapy; (VI) drug-drug interactions; (VII) drug-food interactions; (VIII) drug-disease interactions; (IX) adverse drug reactions; and (X) proper utilization, including overutilization or underutilization. Specific Requirements for Before dispensing an opioid, benzodiazepine, barbiturate, or carisoprodol for a patient SHALL consult the Checking Texas Prescription Monitoring Program (PMP) database to review the patient's controlled substance history. PDMP/Interactions/Indication? Full PDMP can be seen here requirements. Notes on Laws & Requirements FD&C Federal Food, Drug, and Cosmetic Act Durham-Humphrey Amendment First legislation requiring new drugs to be proven safe prior to marketing. Blame the elixir. Established the FDA! such legends!... Just don’t forget the OTC © tl;dr pharmacy llc. All Rights Reserved Kefauver Harris Amendment was all about GMP, advertising and safety! Don’t forget, while the FDA regulates advertising of legend drugs, it’s the FTC that oversees OTC drug advertising. PPPA Poison Prevention Packaging Act (PPPA) Requires child-resistant containers for most legend and OTC drugs. Exceptions include OCPs, sublingual nitroglycerin, prednisone tablets with less than 105 mg per container, methylprednisolone containing less than 84 mg per container and many more found here. Health Insurance Portability and Accountability Act Pro tip: when a patient requests a copy of their PHI, HIPAA requires pharmacies to comply within 30 days. Texas, however, has narrowed that down to 15 days! HIPAA HITECH Health Information Technology for Economic and Clinical Health Act Electronic health record implementation Adulterated vs. Misbranded Adulterated Sec. 431.111 Misbranded Sec 431.112 Recalls FDA Class I Recall Class I Recall is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. FDA Class II Recall Class II Recall is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. FDA Class III Recall Class III Recall is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. Other Recalls Additional Reading Definitions/References Red Book Drug Pricing Orange Book Therapeutic Equivalence Yellow Book International Travel Vaccines Green Book Animal Drug Products Pink Book Purple Book Vaccine-Preventable Diseases Biological Products USP 795 Nonsterile Compounding USP 797 Sterile Compounding USP 800 Hazardous Drug Handling The Prescription Required Fields What Are the Required Elements for a Valid Prescription (ex. Name, DOB, Address, Etc.)? Patient Name (or species of animal and name of owner) (ii) the address of the patient (not required for non-controlled substance if address is readily retrievable in medical records) (iii) the name, address and telephone number of the practitioner and the DEA registration number of the practitioner (if a controlled substance); (iv) the name and strength of the drug prescribed; (v) the quantity prescribed numerically, and if for a controlled substance: (I) numerically, followed by the number written as a word, if the prescription is written; (II) numerically, if the prescription is electronic; or (III) if the prescription is communicated orally or telephonically, as transcribed by the receiving pharmacist; (vi) directions for use; (vii) the intended use for the drug unless the practitioner determines the furnishing of this information is not in the best interest of the patient; (viii) the date of issuance; Prescriptions for controlled substances must be electronic unless exempt under specific conditions in 481.074(b-1), 481.075(j), 481.0755 or 481.0761. What can RPh Correct/Change/Add to Schedule II: a pharmacist may not change name of patient, name of drug, name of physician Prescription (Legend/Controlled)? prescribing or date of prescription. Strength, dosage form, directions and quantity may be changed © tl;dr pharmacy llc. All Rights Reserved provided the pharmacist receives verbal approval from the prescriber and documents the hardcopy of such change. Schedule III-V: The same requirements of a CII apply, however the pharmacist can always just take a new verbal order for a schedule III-V prescription (which we can’t do with schedule II). Legend rxs: Substitutions can be done without the provider’s permission if the product is an AB rated generic, except if the provider has written “brand medically necessary” on the hardcopy. Biosimilar substitution requires the approval of the prescriber. What can non-RPh Pharmacy Staff Correct/Change/Add to a Prescription (Legend/Controlled)? Not specified AB rated generic is allowed without consulting provider. Biosimilars, therapeutic equivalents,etc require provider approval. Technically, we CAN make biosimilar substitutions if the biosimilar meets What Type of Substitutions Are Allowed? certain requirements (currently, no biosimilars are interchangeable and this is unlikely to change). A (Generic, Orange Book Equivalence, switch to a drug providing a similar therapeutic response to the one prescribed shall not be made Therapeutic Substitution, Etc.) without prior approval of the prescribing practitioner. This paragraph does not apply to generic substitution Special Restrictions on Drugs/Refills? When a prescriber is writing a prescription for “acute pain” he or she may only issue a prescription for a 10-day supply with no refills for any opioid. This does not apply for the following situations (Texas Controlled Substance Act Sec. 481.07636): Chronic pain Pain be treated as part of cancer care Pain being treated as part of hospice care or end-of-life care Pain being treated as part of palliative care Special Requirements for Prescription Pads? Not specified, but before 1/1/2021, all written CII prescriptions had to be written on a Texas Official Prescription Form which were provided by the Texas State Board of Pharmacy. Now all controlled substance prescriptions must be issued electronically except in a few instances (TCSA 481.0755) Fax Prescriptions Requirements for Type of Fax Machine? Not specified. But a statement that indicates the prescription was faxed must be included Can Patients Fax Their Prescription? Patients may not fax in their own prescriptions Prescribers from Outside Their Practice? Schedule III-V may be faxed to the pharmacy provided these are faxed from the provider’s office, have What Controlled Schedules are Allowed? the provider’s original signature and include the appropriate contact information. Faxed prescriptions are not allowed from Mexico or Canada unless the prescriber is also licensed in Texas Electronic Rx Must be transmitted directly to pharmacy or through a data communication device that ensures confidential information is not accessed (unless for legal purposes) and that the prescription Requirements for Electronic Prescribing? information is not altered during transmission Prescriptions for controlled substances must be electronic unless exempt under specific conditions in 481.074(b-1), 481.075(j), 481.0755 or 481.0761. Requirements for Certification/Technology? Required Fields on Electronic Prescriptions? Must include (I) the date the prescription drug order was electronically transmitted to the pharmacy, if different from the date of issuance of the prescription; and (II) if transmitted by a designated agent, the name of the designated agent; and Schedule II-V electronic prescriptions are valid in Texas, provided that both prescriber’s and pharmacy’s computer systems meet all of the DEA’s security requirements. Not allowed to receive controlled substance Rxs from Mexico or Canada What Control Schedules Are Allowed? Any changes must follow the paper hardcopy requirements outlined previously. Can RPh Make Changes to Electronic Prescriptions? Prescriptions for controlled substances may be sent electronically from out of state providers. Schedule II out of state prescriptions may be filled in Texas if the pharmacy has established an approved plan by the Texas State Board of Pharmacy. Can Electronic Prescriptions Be Transmitted Across State Lines? Must be transmitted directly to pharmacy or through a data communication device that ensures confidential information is not accessed (unless for legal purposes) and that the prescription information is not altered during transmission Phone Rx What Information Must Be Provided? Who Can Phone in Prescriptions (Prescriber, Staff, Receptionist)? Must include initials or ID code of transcribing pharmacist and the name of prescriber or prescriber’s agent communicating the info A designated agent of a prescriber may call in legend, schedule III-V prescriptions. Can a provider call in a schedule II? Yes, under certain conditions. Yes. If under the supervision of a pharmacist, interns can perform any duty a pharmacist performs Can Interns Receive New Prescriptions except: Via Phone/Voicemail? Refills? (1) present or identify himself/herself as a pharmacist; © tl;dr pharmacy llc. All Rights Reserved (2) sign or initial any document which is required to be signed or initialed by a pharmacist unless a preceptor cosigns the document; or (3) independently supervise pharmacy technicians or pharmacy technician trainees. Can Technicians Receive New Prescriptions Via Phone/Voicemail? Refills? Technicians may only initiate and receive refill authorizations Can Clerks/Cashiers/Others Receive New Prescriptions Via Phone/Voicemail? Refills? No Transfer Rx What Information Must Be Provided? Can Interns Transfer Prescriptions? Must be provided verbally or via fax. The pharmacist transferring the Rx out must void it in their system. The pharmacist receiving the transfer must write TRANSFER in their system. The name, address, and DEA number (if controlled substance) of the receiving pharmacy must be recorded. Also the name of the individual who received transfer. Obviously, cannot transfer more or less than the remaining amount originally prescribed, and cannot transfer an expired prescription. Yes, if supervised by pharmacist. Can Technicians Transfer Prescriptions? No How Many Fills Can Be Transferred? No limitations for legend drugs. C-III to C-Vs may only be transferred once unless pharmacies share an electric, real-time database. Any Specific Rules for Out-Of-State? Not specified Packaging (i) name, address and phone number of the pharmacy; (ii) unique Rx number; (iii) date dispensed; (iv) initials or an identification code of the dispensing pharmacist; (v) Prescriber name; (vi) Signature of pharmacist (if a VORB or TORB) (vii) name of the patient or if such drug was prescribed for an animal, the species of the animal and the name of the owner. The name of the patient's partner or family member is not required to be on the label of a drug prescribed for a partner for a STD or for a patient's family members if the patient Information Required on Label? (List the has an illness caused by a pandemic; Data Elements) (viii) instructions for use (ix) quantity dispensed; (x) appropriate ancillary instructions (xi) if the prescription is for a Schedule II - IV controlled substance, the statement "Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed"; (xii) if generic substitution, include the statement "Substituted for Brand Prescribed" or "Substituted for 'Brand Name'" (xiii) the name and strength of the actual drug or biological product dispensed OTC Label Requirements Child Safety Cap Requirements Labeling Requirements for OTC Drugs A child resistant container is required unless the patient or practitioner requests otherwise or the product is exempt from the Poison Prevention Packaging Act of 1970 Prescription Label Expiration date should not exceed 1 year from dispensing date or manufacturers expiration date, whichever is earlier (Texas Pharmacy Rules Sub Sect 291.33) Expiration/Use-By Date? Prepackaged Drugs The label for a prepackaged medication must contain the facilities beyond-use-date The records for the prepackaged medication must contain the manufacturers original beyonduse-date (Texas Pharmacy Rules Sub Sect 291.33) Med-Pak The expiration date on the label should be the earliest expiration date of any of the medications contained in the med-pak or 1 year from the dispensing of the med-pak, whichever is earlier (Texas Pharmacy Rules Sub Sect 291.33) Label Requirements for Prepackaging? brand name and strength of the drug; or if no brand name, then the generic name, strength, and name of the manufacturer or distributor; facility's lot number; expiration date; and quantity of the drug, if quantity is greater than one. 22 TAC §291.151 © tl;dr pharmacy llc. All Rights Reserved Prescriber Special Authority or Restrictions by Type A prescription is not required when an optometrist administers a topical ocular pharmaceutical agent of Provider? (Dentists, Optometrists, in compliance with the Texas Optometry Act Etc.) Counseling Requirements for Counseling (i) provided to new and existing patients of a pharmacy with each new prescription drug order. A new prescription drug order is one that has not been dispensed by the pharmacy to the patient in the same dosage and strength within the last year; (ii) provided for any prescription drug order dispensed by the pharmacy on the request of the patient or patient's agent; (iii) communicated orally in person unless the patient or patient's agent is not at the pharmacy or a specific communication barrier prohibits such oral communication; (iv) documented by recording the initials or identification code of the pharmacist providing the counseling in the prescription dispensing record as follows: Required Topics to Cover (i) name and description of the drug or device; (ii) dosage form, dosage, route of administration, and duration of drug therapy; (iii) special directions and precautions for preparation, administration, and use by the patient; (iv) common severe side or adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur; (v) techniques for self-monitoring of drug therapy; (vi) proper storage; (vii) refill information; and (viii) action to be taken in the event of a missed dose Disposal/Donation Special Disposal Requirements? Patient Waste/Disposal? Donations? See: Destruction of Dispensed Drugs Not specified, Texas BOP website recommends to follow federal guidance Not specified Drug Take-Back Days? DEA's Take Back Day Are Returns Allowed? Generally not allowed Can Returns be Dispensed? Generally not allowed Controlled Substances Note: Review List of Drugs by Schedule at https://www.deadiversion.usdoj.gov/schedules/orangebook/c_cs_alpha.pdf Prescriptions Special Prescription Pad Requirements? State Specific Restrictions? Not specified, but before 1/1/2021, all written CII prescriptions had to be written on a Texas Official Prescription Form which were provided by the Texas State Board of Pharmacy. Now all controlled substance prescriptions must be issued electronically except in a few instances (TCSA 481.0755) When a prescriber is writing a prescription for “acute pain” he or she may only issue a prescription for a 10-day supply with no refills for any opioid. This does not apply for the following situations (Texas Controlled Substance Act Sec. 481.07636): Chronic pain Pain be treated as part of cancer care Pain being treated as part of hospice care or end-of-life care Pain being treated as part of palliative care Out-of-State or Out-of-Country Out of State is allowed provided the practitioner is allowed to prescribe in that state Allowed? Restrictions by Out of country: No controlled substances from Mexico or Canada can be filled, but pharmacist can fill nonControl Schedule? controlled drugs can be filled if written by licensed professional of the country and there are no refills Separate Registration Required for Prescribing? DEA registration required for providers to prescribe. Separate Registration Required for Dispensing? DEA registration required for pharmacies to dispense. PDMP Requirements? Before dispensing an opioid, benzodiazepine, barbiturate, or carisoprodol for a patient shall consult the Texas Prescription Monitoring Program (PMP) database to review the patient's controlled substance history. Full PDMP can be seen here requirements. Rules on Phone, Fax or Electronic? Prescriptions for controlled substances must be electronic unless exempt under specific conditions in 481.074(b-1), 481.075(j), 481.0755 or 481.0761. Phone: Verbal orders must be received by pharmacist Electronic: C-II to C-V are allowed electronically if submitted directly to the pharmacy or through a special data communication device Fax: C-IIs not allowed. C-III-V are allowed. Cannot accept faxed Rx from Mexico or Canada unless the practitioner is also licensed in Texas © tl;dr pharmacy llc. All Rights Reserved State-Specific Control This is updated annually, so it’s best to check the most recent Texas controlled substances complete list here. Schedules (e.g. Schedule VI)? How Long Is the Prescription C-II: 30 Days Valid? C-III – V: 6 months Days Supply Restrictions? Refills Allowed? Fill-By Dates Allowed? See “State Specific Restrictions” C-II: No, except in emergency situations noted below C-III-V: 5 Refills in 6 months Yes Postdating Allowed? No, all prescriptions must be dated at the time of issuing Partial Fills Allowed? For CII medications (Texas Controlled Substance Act Sec. 481.074): 72-hour rule ○ If the pharmacist does not have enough medication in stock to fill the whole prescription, the customer can come back to the pharmacy and pick up the remaining portion owed within 72-hours. 30-day rule ○ If the prescriber or patient requests, the patient can pick up partial fillings of the CII medication for up to 30-days. 60-day rule ○ Patients that are terminally ill or in a LTCF may receive partial fillings of CII medications for up to 60 days from the written date on prescription. C-II Emergency Prescriptions are allowed. Pharmacist must document the emergency nature of the Rx and Emergency Fill Requirements? attach the official prescription from the practitioner when it arrives. Both documents need to be kept on file for 2 years like all other Rx records. DEA What are the Licensure Requirements? Who Must Apply? Application Requirements? Form 224 (224a for Renewal), $888 Who must apply? Anyone who engages in the legal manufacture, distribution, and dispensing of controlled substances, including those who prescribe and or researches them. DEA Form 224 – Retail Pharmacy, Hospital/Clinic, Practitioner, Teaching Institution, or Mid-Level Practitioner DEA Form 225 – Manufacturer, Distributor, Researcher, Canine Handler, Analytical Laboratory, Importer, Exporter DEA Form 363 – Narcotic Treatment Programs DEA Form 510 – Domestic Chemical The Unique Identification Number (UIN) or “X” number authorizes a DEA registered, Qualified Practitioner (e.g., a physician) under the Drug Addiction Treatment Act of 2000 or Qualifying Other Practitioner (i.e., nurse When Does the DEA No. Have practitioner, physician’s assistant, clinical nurse specialists, certified registered nurse anesthetists, or certified an ‘X’? nurse midwives) under the Comprehensive Addiction and Recovery Act of 2016 and the SUPPORT for Patients and Communities Act of 2018, to prescribe schedule III-V narcotic controlled substances approved by the Food and Drug Administration specifically for maintenance and detoxification treatment. How Do You Validate a DEA Number? What Is Required for Electronic Use? Renewal Cost? Frequency? Two letters followed by seven numbers. First letter: o A, B, F is a full practitioner. X is a full practitioner with buprenorphine privileges. o M is a mid-level practitioner Second letter: First letter of prescriber’s last name Math o Step one: 1st, 3rd, and 5th number are added together. o Step two: 2nd, 4th, and 6th number are added together and multiplied by two. o Step three: Add the products from step one and two together o The 7th number of the DEA number should be equal to the last digit of the number in step three It’s all about CSOS. $888, must be renewed every 3 years. License Update Process? Tools and tools, and tools. Reinstatement Process? If registration within month of expiration, can renew. If later, must reapply. When to Use DEA Forms? (222, 41, 106) 41 – Disposal 222 – Order 106 – Theft/Loss Required Information on Invoices? None specified, but invoices must be stored for at least two years. Overdose/Dependence Rules on Naloxone Administration (1) A pharmacist may dispense an opioid antagonist under a valid prescription, including a prescription issued by a standing order, to: (A) a person at risk of experiencing an opioid-related drug overdose; or © tl;dr pharmacy llc. All Rights Reserved (B) a family member, friend, or other person in a position to assist a person described by subparagraph(A) of this paragraph. (2) A prescription dispensed under this section is considered as dispensed for a legitimate medical purpose in the usual course of professional practice. (3) A pharmacist who, acting in good faith and with reasonable care, dispenses or does not dispense an opioid antagonist under a valid prescription is not subject to any criminal or civil liability or any professional disciplinary action for: (A) dispensing or failing to dispense the opioid antagonist; or (B) if the pharmacist chooses to dispense an opioid antagonist, any outcome resulting from the eventual administration of the opioid antagonist. An individual practitioner may dispense or prescribe Schedule III, IV, or V narcotic controlled drugs or combinations of narcotic controlled drugs which have been approved by the FDA specifically for use in maintenance or detoxification treatment if they are registered as a Qualifying Practitioner or Qualifying Other Practitioner. Both the UIN and the DEA number must be included on the prescription. Rules on Suboxone Administration Prescribing Authority (Mark/Note If Allowed to Prescribe) Type of Provider Schedule I Schedule II Schedule III Schedule IV Schedule V Legend/OTC Methadone Physician Yes Yes Yes Yes Yes Yes Dentist Yes Yes Yes Yes Yes Optometrist No Yes Yes Yes Yes Podiatrist Yes Yes Yes Yes Yes Veterinarian Yes Yes Yes Yes Yes Psychiatrist Yes Yes Yes Yes Yes Physician Assistant Yes (hospital/hospice settings only) Yes Yes Yes Yes Nurse Practitioner Yes (hospital/hospice settings only) Yes Yes Yes Yes Yes Yes Yes Yes Psychologist Registered Nurse Chiropractor Yes (hospital/hospice settings only) Midwife (CNM) Physical Therapist Pharmacist Special Notes on Prescribing Authority (e.g. Classes Allowed by Provider Type) Yes (CDTM) Physician Assistants, Nurse Practitioners (Advanced Practice Providers) CANNOT prescribe C-IIs (except in hospital/hospice settings). They can prescribe C-III to C-V, but they must use their own prescription pad with their own DEA number and the delegating physician’s DEA number See: QUICK REFERENCE GUIDE Refills/Length of Validity (By Control Schedule) Schedule Schedule I Schedule II Schedule III Schedule IV Schedule V Legend/OTC Methadone # of Refills Allowed 0 Up to 5 not to exceed a 6 mo supply Up to 5 not to exceed a 6 mo supply Up to 5 not to exceed a 6 mo supply PRN for up to 12 months for legend drugs 0 How Long is Rx Valid 30 days 6 mos 6 mos 6 mos 12 months for legend drugs 30 days for treatment of pain Medical Marijuana Dispensing Requirements Special Requirements Not specified (i.e. not currently allowed in Texas) Not specified Classification of Pharmacies and Notes Class A - Community Pharmacy TAC §291.1-291.29 If pharmacy does sterile compounding, must obtain a Class A-S license Pharmacist to tech ratio may be up to 1:6 if the max number of pharmacy tech trainees is 3 During pharmacist breaks, at least one pharmacy technician (not trainee) must remain in the pharmacy if the department is still open and previously checked prescriptions may be dispensed Mandatory counseling is required for new prescriptions (this means prescriptions that have not been dispensed to the patient in the same strength and dosage form within the past year) Three types of automated devices that may be used: automated counting devices, automated pharmacy dispensing systems and automated checking device © tl;dr pharmacy llc. All Rights Reserved Class B - Nuclear Pharmacy TAC §291.51-291.55 Class C - Institutional Pharmacy TAC §291.71-291.77 Class D - Clinic Pharmacy TAC §291.91-291.94 Class E - Nonresident Pharmacy TAC §291.101-291.106 Class F - Freestanding Emergency Medical Care Facility Pharmacy TAC §291.151 Pharmacist to tech ratio may be up to 1:6 if the max number of pharmacy tech trainees is 3 Refills of radioactive prescriptions are not allowed The immediate inner container of a radiopharmaceutical shall be labeled with: ○ standard radiation symbol; ○ the words "caution-radioactive material" or "danger, radioactive material"; ○ the name of the radiopharmaceutical or its abbreviation; ○ the unique identification number of the prescription. The outer container of a radiopharmaceutical shall be labeled with: ○ the name, address, and phone number of the pharmacy; ○ the date dispensed; ○ the directions for use, if applicable; ○ the unique identification number of the prescription; ○ the name of the patient if known, or the statement, "for physician use" if the patient is unknown; ○ the standard radiation symbol; ○ the words "caution-radioactive material" or "danger, radioactive material"; ○ the name of the radiopharmaceutical or its abbreviation; ○ the amount of radioactive material contained in millicuries (mCi), microcuries (uCi), or bequerels (Bq) and the corresponding time that applies to this activity, if different from the requested calibration date and time; ○ the initials or identification codes of the person preparing the product and the authorized nuclear pharmacist who checked and released the final product unless recorded in the pharmacy's data processing system. The record of the identity of these individuals shall not be altered in the pharmacy's data processing system. ○ if a liquid, the volume in milliliters; ○ the requested calibration date and time; and ○ the expiration date and/or time. If the facility is engaged in sterile compounding, must obtain a Class C-S license A facility with 101 beds or more must be under continuous supervision by an on-site pharmacist A facility with 100 beds or less must have pharmacist services part-time or on a consulting basis but a pharmacist must be on-site at least once every 7 days There is no set ratio of pharmacists to technicians in a Class C facility Tech-check-tech is an option if the pharmacy has an ongoing clinical pharmacy program Class C-ASC = Class C pharmacies in a free standing ambulatory surgical center A facility/location other than a physician's office, where limited types of dangerous drugs or devices restricted to those listed in and approved for the clinic's formulary are stored, administered, provided, or dispensed to outpatients. Formulary may include: ○ Anti-infective drugs ○ Musculoskeletal drugs ○ Vitamins ○ Obstetrical and gynecological drugs ○ Topical drugs ○ Serums, toxoids, and vaccines Formulary may not include: ○ Nalbuphine ○ Drugs to treat erectile dysfunction ○ Controlled substances May petition the TX BOP for an expanded formulary if serving at least 80% indigent patients The PIC, consultant pharmacist or staff pharmacist must visit the clinic at least monthly Class E pharmacy license or non-resident pharmacy license--a license issued to a pharmacy located in another state whose primary business is to: ○ dispense a prescription drug or device under a prescription drug order and to deliver the drug or device to a patient, including a patient in this state, by the United States mail, common carrier, or delivery service; ○ process a prescription drug order for a patient, including a patient in this state; or ○ perform another pharmaceutical service defined by board rule. Pharmacies must have a license in good standing in their home state The PIC must have a Texas pharmacist license, but other staff pharmacists do not If the facility is engaged in sterile compounding, must obtain a Class E-S license Freestanding emergency medical care facility (FEMCF)--A freestanding facility that is licensed by the Texas Department of State Health Services pursuant to Chapter 254, Health and Safety Code, to provide emergency care to patients. Must have one PIC who is employed or contracted at least on a consulting or part-time basis Must have locked storage for CII’s Must maintain a perpetual inventory of all controlled substances and reconciled at least once in every calendar week that the pharmacy is open A retrospective random drug regimen review must be conducted at least every 31 days © tl;dr pharmacy llc. All Rights Reserved Class G - Centra Prescription Drug Order or Medication Order Processing Pharmacy TAC §291.153 The processing of prescription drug or medication orders by a Class G pharmacy on behalf of another pharmacy, a health care provider, or a payor. Centralized prescription drug or medication order processing does not include the dispensing of a prescription drug but includes any of the following: ○ receiving, interpreting, or clarifying prescription drug or medication orders; ○ data entering and transferring of prescription drug or medication order information; ○ performing drug regimen review; ○ obtaining refill and substitution authorizations; ○ verifying accurate prescription data entry; ○ interpreting clinical data for prior authorization for dispensing; ○ performing therapeutic interventions; and ○ providing drug information concerning a patient's prescription Class G pharmacies do not have a maximum pharmacist to technician ratio © tl;dr pharmacy llc. 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