Texas Pharmacy Law
Grounds for discipline
ceased to engage in the business described for a period of 30 days or longer
PEC Laminar air flood hoods
certified at least every 6 months
Class D clinic formulary may NOT INCLUDE
Nalbuphine (NUBAIN) - partial opioid agonist Drugs to treat ED Controlled Substances
A pharmacist may NOT change the following items on a controlled substance prescription:
Name of the patient Name of the drug Name of the prescribing physician Date of the prescription
Cocaine eye drops
"T" and ""TG" may possess and administer NO GREATER THAN 10% solution of cocaine eye drops in prepackaged liquid form (solution cannot be compounded) ***although they may NOT dispense this must have DEA registration to possess and store CANNOT STORE MORE THAN 2 VIALS
Therapeutically equivalent
pharmaceutically equivalent drugs that when administered in the same amounts will provide the same therapeutic effect, identical DURATION, and INTENSITY
RECORDS of Disbursement of Controlled Substances
***although most pharmacies maintain electronic dispensing records There are specific storage requirements for hard copies of all controlled substance prescriptions TSBP RULES REQUIRE a THREE FILE STORAGE SYSTEM FILE 1: Schedule II FILE 2: Schedules III, IV, V FILE 3: NONSCHEDULED (dangerous drug's and OTC drugs filled as a rx) **only applies to written prescriptions and verbal prescriptions that are reduced to writing by a pharmacist ***if a controlled substance is transmitted electronically, DEA requires that those electronic prescriptions be maintained electronically other records of disbursement: DEA form 106 for loss / theft DEA form 41 for destruction DEA form 222 - for any distributions under the 5% rule invoices for III-V distributions under the 5% rule
Perpetual inventory
**controlled substances required for C-II in Class C (institutional) pharmacies ALL in REMOTE pharmacies ALL in Class C Ambulatory Surgical Centers Class F (Free standing Emergency medical facility)
PMP
**includes meds dispensed to a Texas resident from an OUT OF STATE pharmacy authorized users: pharmacists and interns techs tech trainees PMP AWARxE portal - TSBP site Mandatory use: Practitioners (other than vets) and pharmacists must check the PMP before prescribing or dispensing Opioids, BZDs, Barbiturates, Carisoprodol **not required if the patient has cancer, sickle cell disease, receiving hospice care and it is clearly indicated on the rx or if they cannot access the PMP after making good faith effort **can use a pharmacy management system that integrates data from the PMP - a review of the system with the integrated data meets this requirement
Automated Medication Supply Systems
*Pyxis tests accuracy at least every 6 months or when an upgrade or change is made
1 contact hour (TSBP)
0.1 CEU *continuing education units (ACPE)
CPR
1 hour
TSBP
1 tech
Dihydrocodeine C-III limit
1.8 g/100 mL and 90 mg/dosage unit *** same as codeine
Codeine C-III limit
1.8 g/100 ml and 90 mg/dose unit
TCSA opioid for acute pain
10 days no refills
Opium Federal C-V limit
100 mg/100 mL
Dihydrocodeine C-V limit *only C-V limit differs from codeine and it's half
100 mg/mL
TSBP
11 members
APPE
1440 hours
Renew registration for a pharmacy tech who engages in sterile compounding
2 hours of CE related to compounding if engaged in compounding LOW and MEDIUM risk preparations 4 hours if engaged in compounding HIGH RISK preparations
Codeine C-V limit
200 mg/100 mL
A remote dispensing site may not be located within
22 MILES of a class A pharmacy ** if a Class A pharmacy opens within that mileage restriction after a remote dispensing site is operating - the remote dispensing site may continue to operated MAY NOT DISPENSE C-II if the dispensing site dispenses an average of >125 prescriptions EACH DAY the site is open (calculated annually) - it must apply for a Class A license a pharmacist employed by a provider pharmacy MUST MAKE AT LEAST MONTHLY ONSITE VISITS to a remote dispensing site and must reconcile the perpetual inventory of CS to the on-hand count at the remote dispensing site
TSBP meeting
3 hours
TSBP task force
3 hours
Temporary suspension
3 member panel appointed by the Board president may temporarily suspend or restrict a license if continued practice or operation of a pharmacy would constitute a continuing threat to the public welfare can take place immediately without notice if a hearing is schedule no later than 14 days after the suspension or restriction
TSBP
3 public members
IPPE
300 hours
Media fill test
3x before initially being allowed to compound **exception: is a pharmacist may temporarily compound sterile preparations and supervise pharmacy techs compounding sterile preparations provided they complete the on-site media fill tests within SEVEN DAYS (7)
Pharmacy techs and trainees who compound sterile preparations must complete
40 HOURS of instruction through an ACPE approved course or a training program accredited by the American Society for Health System Pharmacists and complete a structured, on the job training program at the pharmacy which provides 40 hours of instruction and experience
C-III Limit MORPHINE
50 mg/100 mL
Opium TEXAS C-V limit
50 mg/100 mL *******
Opium C-III limit
500 mg/100 mL and 25 mg /dosage unit
TSBP
6 years term appointed by the governor cannot serve more than 2 consecutive full terms
TSBP
7 pharmacist
Partial Dispensing of C-II
72 HOUR RULE - if unable to fill entire QTY of C-II - partial may be dispensed with remaining QTY provided with 72 hours **this also applies to emergency verbal prescriptions for C-II **the patient does not have to pick up within 72 hrs but the pharmacy must have the BALANCE within 72 hrs 30 DAY RULE if requested by the patient or the prescriber - a pharmacist can provide a partial QTY of a C-II and the patient may obtain additional QTYs up to 30 days - applies to written and electronic prescriptions BUT NOT EMERGENCY VERBAL C-II's 60 day RULE for terminally ill and LTCF patients both federal and Texas law allow partial fills of C-II as MANY TIMES AS NEEDED all partial fills must be completed within 60 days
Rural hospital
75 beds or fewer and located in a county with a population fewer than 50,000 or designated as a critical access hospital, rural referral center, or sole community hospital ** a nurse or practitioner may withdraw the drug from the pharmacy in sufficient QTY to fulfill the order if the pharmacist is not on duty or when the pharmacist is closed the hospital pharmacist must verify the withdrawal and perform a drug regimen review no later than 7 days after the withdrawal in rural hospitals when a pharmacist is not on duty, pharmacy technicians may perform the following duties without direct supervision: entering med order and drug distribution information into a computer system Preparing, packaging, or labeling rx drugs pursuant to med orders if a licensed NP or pharmacist verifies the accuracy by electronic supervision before administration to the patient distributing routine orders for stock supplies accessing and restocking automated med supply cabinets ***a nurse or practitioner at the hospital or a pharmacist through electronic supervision must verify the accuracy of the pharmacy tech performing these duties
In facilities with a part-time or consultant pharmacist when the pharmacy is closed:
A designated licensed nurse or practitioner may remove drugs and devices for the patient's immediate therapeutic needs A pharmacist shall verify the withdrawal of the drugs no more than 7 days after the withdrawal
In facilities with a full-time pharmacist when the pharmacy is closed
A designated licensed nurse or practitioner may remove drugs for the patient's immediate therapeutic needs: a pharmacist must verify withdrawal as soon as possible - but NO MORE THAN 72 hours after withdrawal
Class F pharmacy: RETROSPECTIVE random drug regimen review
AT LEAST EVERY 31 days
In texas
All invoices for controlled substances must be INITIALED BY THE RECEIVING PHAMRACIST ***except in Class C-ASC and Class F pharmacies - where they must be signed by the person receiving who does not have to be a pharmacist
Destruction of stock dangerous drugs
Records of destruction are not required
Significant loss
Reported to DEA within ONE BUSINESS DAY **also recommends notifying the police TSBP ALSO requires notification to the BOARD of a theft or significant loss of controlled substances IMMEDIATELY UPON DISCOVERY
Prescriptions for Epinephrine Auto-injector and Asthma Medication
pharmacies are allowed to dispense epinephrine auto-injectors to various entities based on prescriptions without requiring a patient name
Licensure by examination
At least 18 YO completed internship graduated and received professional practice degree passed NAPLEX and MPJE has not had pharmacist license in another state restricted, suspended, revoked, or surrendered
Most suppliers (wholesalers) are required to report the acquisition and disposition of C-II and some C-III-IV controlled substances to DEA's
Automation of Reports and Consolidated Orders System ARCOS the supplier does not need to send a copy of the original DEA form to the DEA because that information is already reported to ARCOS BUTTTTT***** if a supplier is not required to report transactions to ARCOS (pharmacy or practitioner acting as a supplier under the 5% rule) it must submit a copy of the original DEA form 222 to DEA either by mail or by email to [email protected] when acting as a supplier
Class F pharmacy with a part-time or consultant pharmacist
the pharmacist shall verify withdrawals of all drugs AT LEAST ONCE IN EVERY CALENDAR WEEK
Only drugs that may be dispensed under DATA MAT DRUGS DATA WAIVED practitioner
BUPRENORPHINE (Subutex) BUPRENORPHINE + NALOXONE (SUBOXONE) BOTH SCHEDULE III *available in SL form *may be dispensed in a pharmacy treat up to 30, 100 or 275 patients depending on their authorization must be administered within 14 days of DELIVERY **if limit treatment to no more than 30 patients may apply for a waiver without having to meet certain DEA certification requirements related to training, counseling and other ancillary services that are normally required
TCSA and TSBP
C III-V: allow emergency refills using pharmacist's professional judgment *C-II emergency refills not allowed by FCSA or TCSA
Phenmetrazine
C-II
Controlled substance prescribing by TEXAS APRNs / PAs
C-II is not generally permitted except in a hospital based practice under the policies approved by the medical staff patients must be admitted to the hospital for an intended length of stay of 24 hours or greater or be receiving care in the emergency department or have a terminal illness and be under hospice care **C III - V rx's may be prescribed by an APRN/PA in any practice setting but the total QTY prescribed, including any refills, may not exceed 90 day supply **the DEA # of the APRN/PA and the supervising physician must be on the RX
Texas APRN or PA
C-II only in specific situations must have provider DEA #
Phendimetrazine
C-III
ESTIMATED COUNT
C-III - C-V ***UNLESS the container holds >1000 tablets or capsules
Phentermine
C-IV
Antidiarrheal products with opium
C-V
Antitussive products containing CODEINE
C-V
Brivaracetam (BRIVACT)
C-V
Lacosamide (VIMPAT)
C-V
Lomotil Diphenoxylate / Atropine
C-V
Pregabalin (Lyrica)
C-V
Class D pharmacy
CLINIC 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 only to out-patients of the clinic OUTPATIENTS OF THE CLINIC LICENSE - a copy of the CLASS D - pharmacy's policy and procedure manual and formulary is required as part of the application PIC employed or under a written agreement as a consultant to the facility may be the PIC for ANY NUMBER OF CLINICS
Remote Dispensing Sites
Class A PHARMACY (not Class C) may provide tele-pharmacy services at remote dispensing sites staffed by a PHARMACY TECHNICIAN *a remote dispensing site is defined as a location licensed as a tele pharmacy that is authorized by a provider pharmacy must be staffed by an ONSITE PHARMACY TECH who is under the CONTINUOUS SUPERVISION OF A PHARMACIST Pharmacy techs must have worked at least 1 YEAR at a RETAIL PHARMACY during the PAST 3 YEARS and must complete a board approved training program on the proper use of a tele pharmacy system Pharmacy technicians at a remote dispensing site ARE INCLUDED in the pharmacist pharmacy tech ratio **they may not perform extemporaneous sterile or nonsterile compounding but may prepare commercially available medications for dispensing, including reconstitution of orally administered powder antibiotics only CLASS A pharmacy may serve as a provider pharmacy for a remote dispensing site A provider pharmacy may provide pharmacy services at NO MORE THAN 2 dispensing site
Remote healthcare sites
Class A or C pharmacy may provide pharmacy services using a tele pharmacy system at the following remote healthcare sites: RURAL HEALTH CLINIC HEALTH CENTERS (medically underserved populations) FEDERALLY QUALIFIED HEALTH CENTERS Healthcare Facilities located in a MEDICALLY UNDERSERVED AREA or health professions SHORTAGE AREA as defined by HHS ***a pharmacy may not provide remote pharmacy services at a remote healthcare site if a Class A or Class C pharmacy that dispenses rx drug order to outpatients is located in the same community ***this rule does not apply to federally qualified health centers Community: defined as WITHIN 10 MILES if not in a metropolitan statistical area
Perpetual inventories for all controlled substances
Class C ---> PERPETUAL inventory for C-II Class C ACS --> perpetual inventory for all controlled substances Class F --> Free standing Emergency Medical Center --> perpetual inventory for all controlled substances REMOTE LOCATION (all pharmacies at a remote location) --> must maintain a perpetual inventory of any controlled substances
TSBP requires the initials of the receiving pharmacist on invoices for controlled substances EXCEPT in:
Class C-ASC and Freestanding Class F pharmacies ***pharmacists initials are not required because there may not be a pharmacist present **instead the person receiving all rx drugs is required to sign for his or her receipt in Class C-ASC and Class F pharmacies
Class D
Clinic
MAT Medication Assisted Treatment for Opiate Dependence
DATA 2000 - office based practitioners to prescribe certain C III -V drugs to treat opiate dependence through a risk management program outside of a narcotic treatment program - use of meds and counseling to treat opioid use --> Medication Assisted Therapy (MAT) authorized under the Act, called a QUALIFIED PRACTITIONER (or DATA WAIVED) **can apply for a waiver if they meet certain criteria provided by SAMHSA and they are provided an identification or "X" code that must be included with the prescriber's DEA number
Multiple prescriptions for C-II
DEA and TEXAS law permit an individual practitioner to issue multiple C-II prescriptions on the SAME DAY authorizing the patient to receive a total of no more than 90 day supply of a C-II ***they must be dispensed within 30 days after the earliest fill date indicated ** they do not have to be presented to the pharmacy within 30 days after the date issued this 90 day supply limit ONLY applies when the prescriber is issuing MULTIPLE PRESCRIPTIONS for a C-II on the SAME DAY with instruction that some of the prescriptions are not to be filled until a later date ***except for OPIOID drugs for treatment of acute pain, there is LEGALLY NO QTY LIMIT ON A SINGLE CONTROLLED SUBSTANCE IN TEXAS however, insurance may limit the amount that may be filled on a single rx and pharmacists should exercise their corresponding responsibility on every rx
compounding of narcotic controlled substances
DEA limits on "aqueous or oleaginous solutions or solid dosage forms" to NO MORE THAN 20% concentration >20% is considered manufacturing -even if the pharmacist has an rx the narcotic substance MUST be compounded with ONE or MORE NONNARCOTIC THERAPEUTIC AGENTS Concentrations limits: Codeine C-V limit: 200 mg/100 mL C-III limit: 1.8 /100 mL and 90 mg/dosage unit
Must be kept in the pharmacy
DEA order forms (COPY OF DEA FORM 222) Prescriptions Inventories
Disposal of controlled substances collected from ultimate users and other non-registrants
DEA rules allow pharmacies to modify their DEA registrations to serve as a collector *must meet requirements for collection receptables and may also provide a mail-back program ** IF DESTROYED ONSITE: DEA FORM 41: has separate section for "collected substances" instead of indicating the specific controlled substances being destroyed, it requires the unique identification number of the inner liner from the collection receptable or the mail-back package
TSBP
Does not regulate drug wholesalers *unlike some states wholesalers are regulated by the texas department of state health services
cannabidiol drug derived from cannabis - not from hemp
EPIDIOLEX not scheduled
Single copy DEA form 222
Effective October 30, 2019, DEA finalized new rules to transition from a triplicate DEA Form 222 to a single copy DEA form 222 with additional security features. There is a 2-year transition period during which existing triplicate DEA Forms 222 can continue to be used as of October 30th, 2021 - only the singly copy DEA form 222 can be used contain 20 ORDER LINES per FORM the purchaser filling out a single copy: must MAKE A COPY of the ORIGINAL FORM for its records and submit the original form to the supplier **it can be kept electronically - the copy of DEA from 222 form does not need to be stored on a different server or system from the purchaser's other records **it may be stored on a system at a location different from the registered location but the forms must be readily retrievable at the registered location **the supplier may only fill an order from the ORIGINAL FORM and not from a copy **the supplier must record on the original form the # of containers furnished for each ordered item and the date the products are shipped to the purchaser PURCHASER writes the DEA # of the SUPPLIER on the FORM *********but if it is omitted, the supplier may complete that part of the form
change of location or change of name
the pharmacy must file a new application and return the old license TSBP actually issues an amended license *previous license # does not change
Verbal
FCSA - allowed for III-V and emergency II TCSA - allowed only in an emergency for all controlled substances but pharmacist is not responsible for determining if all requirements are met ****
Written prescriptions
FCSA: allowed for III-V and required for C-II TCSA - only allowed if exception to e-prescription applies or prescriber has a waiver
Theft or significant loss
FORM 106 ** can be filled out online at DEA's website submitting the FORM immediately is not necessary if the pharmacy needs time to investigate the facts, but initial notification must be provided IN WRITING to DEA WITHIN ONE BUSINESS DAY of DISCOVERY TSBP
Remote pharmacy services
FOUR types of remote pharmacy practices in which drugs may be stored and /or dispensed from locations where a pharmacist is NOT present 1. Emergency Medication Kits at nursing homes 2. Automated Pharmacy Systems for routine dispensing of drugs at certain healthcare facilities including nursing homes 3. Telepharmacy Systems used for dispensing drugs at remote dispensing sites and certain remote healthcare sites 4. Automated Dispensing and Delivery Systems at locations outside a pharmacy
Student intern designation expires if the person:
Fails NAPLEX / MPJE Fails to take NAPLEX and or Texas MPJE within 6 calendar months after graduation
Records
Federal - 2 or 3 file TSBP requires THREE SEPARATE FILES 1: C-II 2: III-V 3: dangerous drugs and OTC
C-II - IV
Federal Transfer Warning "Caution: Federal Law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed" the only exception would be for a controlled substance dispensed in a "blinded" clinical study **not required for C-V or dangerous drugs (non-controlled)
Class D clinic
Formulary: Anti-infective drugs Musculoskeletal drugs Vitamins Obstetrical and gynecological drugs Topical drugs Serums, toxoids, and vaccines
Schedule I
Heroin Dihydromorphine Marijuana LSD Peyote Mescaline Methaqualone
Exemptions to use an official prescription form
Hospital INPATIENT med orders Hospital INPATIENTS requiring emergency QTY of a C-II on discharge - limited to a SEVEN DAY SUPPLY and must be dispensed by the HOSPITAL PHARMACY life flight helicopter medical team emergency medical ambulance crew or paramedic emergency medical technician INMATE - operated by the Texas Department of Criminal Justice Animals - animal hospital, wildlife parks, exotic game ranches, wildlife management programs, state or federal research facilities THERAPEUTIC OPTOMETRISTS administering TOPICAL COCAINE as permitted under the Texas Optometry Act Prescriptions from Out-Of-State practitioners if the pharmacy has a plan approved by TSBP Electronic prescriptions YOU CAN WRITE a C-II and another substance TOGETHER on an official prescription form - each drug is valid ** a direct image must be maintained separately for each category of rx in the pharmacy's rx records
Vicodin
Hydrocodone with acetaminophen Schedule II
Breach affecting >500 individuals
the secretary of HHS AND prominent local media must be notified in addition to the affected individuals within 60 days after the breach is discovered
BSA if used for hazardous drugs ***they must be a Class II or III vertical cabinet and be located in an
ISO 7 area **if used for nonhazardous preparations, they must be located in a buffer area
Low risk
ISO class 5 or better single transfer of sterile dosage forms and manually measuring no more than 3 manufactured products to compound drug admixtures must be stored 48 HOURS at room temperature 14 DAYS if cold (refrigerated) 45 DAYS if frozen
Class C
Institutional (Hospital)
High risk
NONSTERILE or exposed to air quality inferior to ISO Class 5 for more than 1 hour or nonsterile water containing preparations are exposed more than 6 hours before being sterilized Room temperature: 24 hours Fridge: 3 days Frozen: 45 days
Refills of radioactive prescriptions
NOT ALLOWED
QTY LIMITS for OPIOIDS for ACUTE PAIN
MAY NOT EXCEED 10 DAY SUPPLY IN TEXAS **does not limit how many times this may occur NO REFILLS ****OPIOID DRUGS and ONLY for ACUTE PAIN ***not all opioid drugs are C-II and not all C-II's are opioids Acute pain: TIME LIMITED the normal, predicted, physiological response to a stimulus such as trauma, disease, and operative procedures DOES NOT INCLUDE: chronic pain cancer care hospice palliative care **the QTY and refill limits do not apply to a prescription for an opioid approved by the FDA for the treatment of SUBSTANCE ADDICTION that is issued by an authorized practitioner the law provides that a dispenser: IS NOT SUBJECT TO CRIMINAL, CIVIL, OR ADMINISTRATIVE PENALTIES for dispensing or refusing to dispense a controlled substance under a prescription that exceed the limits provided above
Records of controlled substances
Maintain for 2 years
Expanded formulary in class D clinic
May petition TSBP for an expanded formulary if serving at least 80% indigent patients Additional requirements if using an expanded formulary: supportive personnel providing drugs must be licensed nurses or practitioners must have policies and procedures for drugs on the formulary that require special monitoring Retrospective drug regimen reviews of a random sample of clinic patients - MUST BE DONE ON A QUARTERLY BASIS if the pharmacy provides antipsychotic drugs - therapy must be initiated by a physician of the clinic **must be physically examined by a physician at least YEARLY
Compounding aseptic isolators
Must be placed in an ISO Class 7 buffer area
VERBAL and FAX Controlled Substance Prescriptions
Must obtain a valid electronic or written prescription WITHIN 7 DAYS DEA permits prescriptions for C III-V controlled substances to be communicated verbally to a pharmacist by a practitioner or his agent the TCSA technically only allows prescriptions for C III -V controlled substances to be communicated verbally in an emergency fortunately TSBP has indicated that pharmacists may dispense C III -V controlled substance pursuant to an otherwise valid VERBAL rx because TSCA technically requires an emergency for C-III-V verbal prescriptions to be valid, the statue also requires that WITHIN 7 DAYS of issuing an emergency verbal rx, the prescriber must provide an ELECTRONIC RX to the pharmacy **technically may not be done because not required by DEA FAXED prescriptions are generally treated the same as verbal Fax prescriptions are valid for C III -V under federal law but technically must meet emergency requirements under TCSA *must have original signature
Canadian or Mexican Practitioner
NO C III - V
Out of state NP or PA
NO CIII -V
Morphine C-V limit
NONE NO MORPHINE products are C-V either C-II or C-III
Class E
NONRESIDENT
Class B
NUCLEAR
Communication with prescriber
No later than 3 days after dispensing a biological product, the dispensing pharmacist or designee shall communicate to the prescribing practitioner the specific product provided to the patient including NDC **can be done by making an entry into a medical records system or prescription claim system that is accessible to the prescriber *** only required for the BIOLOGICAL PRODUCT
Nuclear Pharmacist to Pharmacy Technician Ratio
No more than 1:6 as long as the max number of techs is 3
Newly scheduled drugs or drugs moved from one schedule to another must be inventoried
ONE THE DAY scheduled or moved to a new scheduled DEA requires biennial (every 2 years) inventory but TSBP RULES REQUIRE AN ANNUAL INVENTORY
Dependent authority
PA APRN
high risk compounding
PEC must be located in a buffer area - minimum differential positive pressure of 0.02 to 0.05 inches water column
Inventory requirements
PIC is responsible for ensuring all inventories are taken must be maintained in pharmacy filed separately from other records be available for 2 years all stock on hand of controlled substances - including expired drugs person taking inventory and PIC shall sign and date the inventory and indicate the time inventory was taken signature of PIC and date of the inventory NOTARIZED WITHIN 72 HOURS or THREE WORKING DAYS for all inventories except for the initial inventory and change in PIC inventory **** the PIC is responsible for making an exact count of all C-II's the PIC is also responsible for making an estimated count of C III - V provided the container has FEWER THAN 1000 tablets/capsules
Class D pharmacy
PIC, consultant pharmacist, or staff pharmacist must personally visit the clinic at LEAST MONTHLY Clinics operated by state or local governments or funded by government sources may petition TSBP for an alternative visitation schedule ****
Transfer to an authorized reverse distributor
PREFERRED METHOD OF DESTRUCTION simply a transfer from one DEA registrant (pharmacy) to another (reverse distributor) A DEA form 41 is NOT REQUIRED because it is a transfer the transfer must be documented with an invoice for schedule III - V controlled substances and a DEA form 222 for schedule II substances
Independent RX authority
Physician Dentist Podiatrist Vet Optometrist - therapeutic optometrists and optometric glaucoma specialists
APRN / PA limit
Physician may not supervise more than 7 APRNs or PAs, except in medically underserved areas or in a facility based practice in a hospital or long term care facility written rx's must have name, address, telephone #, identifying number of the supervising physician as well as the APRN or PA **label is only required to list the prescribing APRN/PA for rx for child <2 - must consult delegating physician
Prescriptive authority who can prescribe controlled substance prescriptions is determined by STATE LAW TEXAS LAW AUTHORIZES THE FOLLOWING PRACTITIONERS to PRESCRIBE CONTROLLED SUBSTANCES
Physicians: MD/DO Dentists Podiatrists Veterinarians Therapeutic Optometrists and Optometric Glaucoma Specialists (with some limitations) Advanced Practice Registered Nurse and Physician Assistants practicing in TEXAS ****may prescribe schedule III - V **in some practice settings schedule II
In facilities with 101 beds or more the following duties may be performed under physically present pharmacist supervision:
Prepackaging and labeling unit-dose and multiple-dose packages Preparing, packaging, compounding, or labeling rx drugs pursuant to med orders compounding nonsterile drugs compounding sterile drugs (C-S only) Bulk compounding or batch preparation distributing routine orders for stock supplies to patient care areas entering med orders and drug distribution info into a computer system loading unlabeled drugs into an automated compounding or counting device accessing automated medication supply systems
Electronic Prescribing for Controlled Substances (EPCS)
Prescriber requirements: 3rd party certification system credentialing to verify authorization to prescribe TWO FACTOR authentication for providers who sign an EPCS rx Pharmacy requirements: 3rd party certification system ability to SIGN and ARCHIVE the controlled substance rx the system must electronically accept and store all the information that DEA requires to document the dispensing of a rx the system must allow the pharmacy to LIMIT ACCESS for the annotation, alteration, or deletion of controlled substance prescriptions to specific individuals or roles must have INTERNAL AUDIT TRAIL that documents whenever a rx is received, altered, annotated, deleted must conduct an internal audit DAILY that identifies any potential security problems, and the system must generate a REPORT FOR REVIEW by the pharmacy if a problem is identified MUST BE BACKED UP DAILY electronic prescription records must be kept electronically. No hard copy is required to be kept
Closing pharmacy
Prior to closing: 14 days prior PIC Must notify the DEA, post a CLOSING NOTICE (name, address, phone # of the pharmacy acquiring the records) Closing Day: the PIC must take a closing inventory transfer rx drug order files and patient medication records remove all signs that indicate the location is a pharmacy After closing: within 10 days after closing, the PIC must provide to TSBP a written notice of the actual date of closing, the pharmacy license, a statement that an inventory was conducted, the manner in which dangerous drugs and CS were transferred or disposed of, and the name and address of the pharmacy to which records were transferred a notification must be sent to a DEA divisional office explaining that the pharmacy has closed, along with the DEA registration certificate, and any unused DEA forms 222 which have been voided
Amobarbital
Schedule II
Cocaine
Schedule II
Meperidine
Schedule II
Pentobarbital
Schedule II
Phenmetrazine
Schedule II
Secobarbital
Schedule II
Anabolic steroids Testosterone Ketamine Paregoric
Schedule III
Benzphetamine
Schedule III
Chlorphentermine
Schedule III
Phendimetrazine
Schedule III
Suppository form of: Pentobarbital Amobarbital Secobarbital
Schedule III
Alprazolam
Schedule IV
Butorphanol
Schedule IV
Carisoprodol
Schedule IV
Chloral Hydrate
Schedule IV
Diazepam
Schedule IV
Diethylpropion
Schedule IV
Lorazepam
Schedule IV
Narcotic DEXTROPROPOXYPHENE and products with no more than 1 MG of DIFENOXIN and no less than 25 micrograms of atropine sulfate per dosage unit
Schedule IV
PHENOBARBITAL
Schedule IV
Pentazocine
Schedule IV
Phentermine
Schedule IV
TRAMADOL
Schedule IV
Cheracol Robitussin AC
Schedule V REQUIRE a rx in TEXAS contain the max amount of codeine allowed for schedule V
1st interchangeable biosimilar biological product
Semglee Lantus
Class B pharmacy INNER container albel
Standard radiation symbol Caution radioactive material or danger radioactive material name of radiopharmaceutical
Mandatory electronic prescriptions for controlled substances
TEXAS made it MANDATORY that all prescriptions for controlled substances be issued electronically starting: January 1, 2021 UNLESS a specific exemption applies or in case of an emergency EXEMPTIONS: a rx for a controlled substance is not required to be issued electronically and may be issued in writing (non verbally) for the following: written by VET temporary technological or electronic failure by a practitioner to be dispensed by a pharmacy located outside of Texas when the prescriber and dispenser are in the SAME LOCATION or UNDER THE SAME LICENSE in circumstances where necessary elements are not supported by the most recently implemented national data standard that facilitates electronic prescribing for a drug which DEA requires additional information in the rx that is not possible with e-prescribing for a non-patient specific rx pursuant to a standing order, approved protocol for drug therapy, collaborative drug management, or comprehensive medication management, in response to a public health emergency research protocol by a practitioner who has received a WAIVER from the requirement to use electronic prescribing - waivers must be issued by the agency that licenses the practitioner and are valid for ONE YEAR but can be renewed reasonably determines that it would be impractical for the patient to obtain the drugs prescribed under the provisions for e-prescriptions in a timely manner and that delay would adversely impact the medical condition a medication order written for a patient who is admitted to a hospital at the time the order is written and filled
Dispensing information for controlled substances must be transmitted to TSBP no later than
THE NEXT BUSINESS DAY after the DATE the RX WAS FILLED if a RX is partially filled - the information must be transmitted no later than the next business day after the rx is completely filled a pharmacy that does not dispense any controlled substances during a period of SEVEN CONSECUTIVE DAYS must send a report to TSBP MUST MAKE CORRECTIONS - for errors submitted to PMP within 7 days of identification Pharmacist is responsible for making sure that the following rx info is transmitted to TSBP: RX CONTROL # DEA # of prescriber Patients or animal owners name, age or DOB, address (city, state,zip) Date issued and filled NDC # of the controlled substance dispensed QTY OF CONTROLLED SUBSTANCE DISPENSED RX # of pharmacy DEA # of pharmacy
Change of location
TSBP must be notified in writing at least 30 days before the change
Texas Law
TSBP rule 291.28 requires pharmacies to reply to a request from a a patient for a copy of his or her confidential information within 15 days, which is stricter than HIPPA (30 days) *comply with a request to amend or for an accounting of disclosure within 60 days
Security
TSBP specifies: Class C Class C-S Class C- ASC Class F must have LOCKED STORAGE for C-II
out of state Canadian / Mexican practitioners
Texas definition of "practitioner" includes persons licensed in other states, Canada, Mexico in a health-care field who can legally prescribe dangerous drugs pharmacists can fill prescriptions for a DANGEROUS DRUG from a physician, dentist, podiatrist, vet, optometrist from another state for Canadian and Mexican practitioners, the rx MUST BE WRITTEN pharmacists can also fill out of state APRN and PA prescriptions for dangerous drugs but CAN NOT fill prescriptions for controlled substances from out of state APRNs and PAs
C-II
Texas pharmacist / optometrist / glaucoma specialist cannot prescribe no out of state practitioners no Canadian or Mexican
Licensing
there is no grace period when renewing a pharmacist license if you fail to renew your license on time, you cannot legally practice
Dispensing directive
Written prescriptions: a practitioner may prohibit the substitution of a generically equivalent drug or interchangeable biological product by WRITING ACROSS THE FACE OF THE RX, in the practitioner OWN HANDWRITING the phrase "BRAND NECESSARY" or "BRAND MEDICALLY NECESSARY" Two-line rx forms, check boxes, or other notations on an original rx drug order which indicate "substitution instructions" are NOT VALID methods to prohibit substitution, and a pharmacist may substitute on these types of prescriptions the dispensing directive may NOT be preprinted, rubber-stamped, or otherwise reproduced on the prescription
Federal scheduling authority for controlled substances
U.S Attorney General as head of the Department of Justice (which DEA is under) may add, delete, or reschedule substances
change of pharmacy ownership
WITHIN 10 days and new license required
Interchangeable
a biological product that is designated as BIOSIMILAR and THERAPEUTICALLY EQUIVALENT to another product approved by the FDA
Accelerated refills and 90 days supply
a pharmacist may dispense up to a 90 day supply of a dangerous drug (no controlled substances) from a prescription that specifies for a lesser amount if: the total QTY dispensed does not exceed the total prescribed including refills the patient consents to the dispensing the physician has been notified electronically or by telephone the drug is not a psychotropic drug *** the patient is at least 18 YO ****
Substitution of dosage form
a pharmacist may dispense, with the patient's consent and notification to the prescriber, a dosage form of a drug product different from that prescribed, such as a tablet instead of a capsule Requirements: must contain the IDENTICAL AMOUNT of the ACTIVE ingredient as the dosage prescribed Is NOT an enteric-coated or time-released product Does not alter clinical outcomes
To dispense Naloxone:
a pharmacist must have a standing order with a physician to dispense an opioid antagonist such as naloxone without an individual prescription many chain pharmacies have standing orders that cover all their pharmacies in Texas the Texas Pharmacy Association also has a standing order that members can access after they complete training
Texas rules also require that
a pharmacist verify that controlled substances listed on a supplier's invoice were actually received by recording on the invoice HIS OR HER INITIALS and the ACTUAL RECEIPT DATE **the purchaser or the person obtaining the product always provides the original DEA form 222 to the supplier and makes a copy for their records
Transfer of controlled substances - Between Registrants The 5% rule
a pharmacy does not have to register with DEA as a distributor as long as total QTYs of controlled substances distributed during a 12-month period in which the pharmacy is registered do not exceed 5% of the total QTY of all controlled substances dispensed and distributed during that same 12-month period EX: if pharmacy dispenses and distributes 10,000 doses of all controlled substances then 10,000 x .05 = 500 allowed to transfer 500 doses without being registered with DEA as a distributor ***if the transfer is for a C-II, a DEA form 222 is required for III-V --> an invoice provided by the supplier is required
Central recordkeeping
a pharmacy wishing to maintain shipping and financial records at a central location other than the registered location must NOTIFY the NEAREST DEA DIVERSION FIELD OFFICE **unless the pharmacy is notified by the DEA that permission to keep the central records is denied, the pharmacy may begin MAINTAINING CENTRAL RECORDS 14 DAYS AFTER NOTIFYING THE DEA **central records shall NOT include executed DEA order forms (Copy of DEA form 222) / PRESCRIPTIONS / INVENTORIES
Administration and Provision of Dangerous Drugs by Physician
a physician may provide 72 hour supply of dangerous drugs (no controlled substances) in their office to meet immediate therapeutic needs in certain rural areas and where there is no pharmacy may dispense dangerous drugs to patients and be reimbursed for the cost VETS are allowed to dispense to their own patients without being licensed as a pharmacy
Verbal prescriptions
a practitioner may prohibit the substitution of a generically equivalent drug or interchangeable biological product by specifying "brand necessary" or "brand medically necessary" on a verbal rx for a MEDICAID patient - the practitioner must also MAIL OR FAX a WRITTEN EX with the WRITTEN DISPENSING DIRECTIVE to the pharmacy WITHIN 30 DAYS
Prescriber dies
acceptable practice for a pharmacist to provide a 30-day supply of the medication and inform the patient that he or she needs to find a new practitioner
Tylenol #3
acetaminophen with codeine Schedule III
EXACT COUNT
all C-II's
Remote pharmacy services using an Emergency Medication Kit
allows a Class A or C pharmacy or a Class E pharmacy located within 20 miles of a facility to provide pharmacy services to facilities licensed under Health and Safety Code Chapter 242 or Chapter 252 (Intermediate Care Facilities for the Mentally Retarded) using an emergency medication kit It also allows a U.S Department of Veterans Affairs pharmacy or other federally operated pharmacy to provide pharmacy services using an Emergency Medical Kit *must submit application to TSBP before providing these services DEA requires automated dispensing systems in long-term care facilities to be registered with DEA however - if it's used solely as an emergency kit - and not for routine dispensing of CS - a DEA registration is not required Access to the emergency medication kit is limited to pharmacists and healthcare personnel employed by the facility contents - consultant pharmacist, PIC, medical director, director of nursing **no specific QTY limit stocking must be done by a pharmacist / pharmacy technician / pharmacy technician trainee unless the system uses barcoding, microchip, or other technologies (automated pharmacy system)
TSBP
allows automatic refill for C IV-V *not C-III
HITECH ACT
amended HIPAA to strengthen it: added a breach notification requirement that requires - notify individuals of a breach of their "unsecured" PHI within 60 CALENDER DAYS after the breach is discovered
Class B pharmacy
amount of radioactivity in MILLICURIES or MICROCURIES or BEQUERELS and the corresponding time that applies to this activity if different from the requested calibration date and time **on outer container in addition to: name, address, phone # of pharmacy date dispensed directions for use Rx number name of the patient if known or for physician use radiation symbol the words "Caution -Radioactive Material" or "Danger - Radioactive Material" Name of the radiopharmaceutical Amount of radioactivity Initials or ID code of person preparing volume in mL if liquid Requested calibration date and time expiration date and time
TSBP
annual inventories most inventories must be signed by the PIC and NOTARIZED WITHIN 3 days excluding sat, sunday, federal holiday
Class C w/ 100 beds or fewer
at least part time pharmacist or on a consulting basis the pharmacist must be ON SITE at least ONCE every 7 days
Administrative penalty
cannot exceed $5000 per violation but every day a violation occurs is a separate violation civil penalties for license violations and unlawful practice can be as much as $1000 per day
CSOS allow electronic orders
based on digital certificates issued by the DEA Certification Authority that are valid until the expiration of the DEA registration for the facility 3 years the CSOS Certificate expires when the DEA registration of the facility expires, it is issued to INDIVIDUAL SUBSCRIBERS *certificates must never be used by anyone other than the individual subscriber
DEA requires that records and inventories of C-II
be kept separately from all other records *C III-V must be maintained separately or be "readily retrievable" from other records ***means the record is kept or maintained in such a manner that it can be separated from all other records in a reasonable time or that it is identified by an ASTERISK, A REDLINE, or some other identifiable manner that is easily distinguishable C-II: COPY OF DEA 222 - # of containers and date received filled in C-III - C-V: Supplier's invoice
Hour requirements
board rules dictate the # of hours required by ACPE 300 hours of IPPE 1440 hours of APPE *an intern cannot receive credit for more than 50 hours / week
Board Order
can be appealed to a Texas district court, but a motion for a rehearing must first be filed with TSBP
DESIGNATED AGENTS
can communicate a rx for C-III - C-V when an electronic rx is not REQUIRED but CANNOT authorize or prescribe an authorized agent of the prescriber (employee or non-employee) may NOT verbally communicate emergency C-II prescriptions to a pharmacist **this task CANNOT BE DELEGATED DEA requires that for a non-employee of the prescriber to quality as an agent of the prescriber, there must be a FORMAL WRITTEN APPOINTMENT of the agent by the prescriber ***important for nursing homes, where the nurses may not be employees of the physician but may wish to call in a rx to a pharmacy on behalf of the physician
Public members of TSBP (3) *includes spouse
cannot be part of a occupational regulatory agency employed by or participate in the management of a business or other entity regulated by the Board or receiving funds from the Board an owner or person who controls more than 10% interest in a business or other entity regulated by the Board or receiving funds from the Board\ affiliated with Texas Trade Association
Pharmacy members of the TSBP (7) *includes spouse
cannot be: a lobbyist on behalf of a profession regulated by the Board An officer, employee, or paid consultant to a Texas trade association in the healthcare field
Nuclear pharmacy
class B also regulated by the Texas Department of State Health Services through its radiation control program (radioactive material license) Authorized Nuclear Pharmacist: Must be a Board of Pharmaceutical Specialties (BPS) Certified Nuclear Pharmacist Must complete 700 hours of a structured education program: 200 hours of didactic training approved by the TDSHS Radiation Control Program and 500 hours of supervised experience
Emergency dispensing of C-II pursuant to verbal prescription
communication must be from the prescriber No alternative treatment available, it is not possible to provide a written prescription the QTY prescribed and dispensed must be LIMITED to the AMOUNT NEEDED to treat the patient during the EMERGENCY PERIOD must be immediately reduced to writing WITHIN 7 DAYS the prescribing practitioner must furnish the pharmacist a valid electronic prescription ************* *DEA permits written or electronic prescription within 7 days BUT TEXAS LAW SPECIFIES an ELECTRONIC PRESCRIPTION must BE PROVIDED but if the practitioner has a waiver, it would make sense that they would need to send a written rx ***remember the QTY that may be prescribed verbally in an emergency is not limited to a specific days supply it is the AMOUNT needed to treat the patient during the emergency period the only time limit is the 7 days required when the prescriber must send an electronic prescription
Class A
community
Equipment and supplies
computer and printer refrigerator child resistant, light resistant, tight, glass containers rx, poison and other labels METRIC/APOTHECARY WEIGHT and MEASURE CONVERSION CHARTS class A RX BALANCE if the pharmacy compounds rx drug order
Combat Methamphetamine Epidemic Act of 2005
control sale of OTC products containing precursor chemicals used in illicit manufacturing of meth PSEUDOEPHEDRINE phenylpropanolamine ephedrine "listed chemical products" ***law only impacts pseudoephedrine because the other two were removed from the market Listed chemical - subject to the following requirements: Display restrictions: behind a counter or in a locked cabinet on selling floor ***within 30 feet in the direct line of sight of the pharmacy counter Retail sales limit: 3.6 g of base product per day 9 grams of base product per 30 days Pseudoephedrine HCL: daily limit of 3.6 grams of base product equals: 146 of 30 mg tablets 73 of the 60 mg tablets 36 of the 120 mg tablets
Class C LIBRARY
current copies of: Texas pharmacy Act and rules Texas Dangerous Drug Act and rules Texas Controlled Substances Act and rules Federal Controlled Substances Act and rules Drug interaction reference General drug information reference Injectable drug products reference Basic antidote information and phone # of the nearest regional poison control center Metric/apothecary weight and measure conversion chart
Remedial plan unless:
death hospitalization commission of a felony unlicensed practice audit shortages diversion of CS impairment unauthorized dispensing gross immorality fraud deceit misrepresentation disciplinary action in another state ***remedial plans are not considered formal disciplinary action but are public documents REMOVED FROM LICENSEE'S RECORD AFTER 5 YEARS
C-III - C-V
documented by a pharmacy with an INVOICE provided by the wholesaler or manufacturer the invoice must contain: NAME of controlled substance Dosage form and strength number of units per container (100-tablet bottle) QTY received (containers) Date of receipt Name, address, and DEA number of REGISTRANT from where controlled substance was received
What may be changed on a controlled substance prescription:
drug STRENGTH DOSAGE form QTY DIRECTIONS for USE may be changed provided the pharmacist: contacts the prescribing practitioner and receives verbal permission AND documents on the rx (or electronic record) that the change was authorized, the name or initials of the individual granting the authorization, and the pharmacist's initials
Pharmaceutically equivalent
drug products having identical amounts of the SAME ACTIVE CHEMICAL INGREDIENT in the SAME DOSAGE FORM
Class C-ASC if the facility has a full time pharmacist
drugs withdrawn from a class C-ASC pharmacy must be reviewed by a pharmacist WITHIN 72 HOURS for CONTROLLED SUBSTANCES and at a REASONABLE INTERVAL but at least ONCE PER CALENDER WEEK for dangerous drugs
Texas Pharmacy Act
establishes the TSBP
Floor stock records
every 30 days
Grounds for discipline
failed to engage in business described - within 6 months of issuance
DEA from 224
for dispensers (practitioners and pharmacies) application for registration *may authorize POA Exemptions: an agent or employee of any registered manufacturer, distributor, or dispenser if acting in the usual course of business or employment (pharmacist working in a pharmacy and nurses working in a hospital or physicians office) a common or contract carrier or warehouseman or an employee whose possession is in the usual curse of business or employment An ultimate user (patient) who possess a controlled substance for a lawful purpose: officials of the U.S Armed Services / Public Health Service / Bureau of Prisons acting in the course of their official duties ***in Texas these federal practitioners can issue electronic schedule II PRESCRIPTIONS - however they can't issue written schedule II prescriptions to be filled off base or out of the facility
Facsimile Rx for C-II
generally treated the same as verbal rx's and are not valid for C-II's DEA permits faxed rx's to serve as the original prescription in THREE LIMITED SITUATIONS: 1. to be COMPOUNDED for the direct administration to a patient by parenteral, IV, IM, SC, intraspinal infusion 2. RESIDENT of LTCF 3. Enrolled in HOSPICE certified or paid for by MEDICARE or LICENSED by the STATE **must note on the rx that the patient is a hospice patient **the patient need not be in a hospice facility and may be in a home-based program as long as they are enrolled in a hospice program **the Faxed RX would need to contain the Texas Official Prescription form, however
Evaluation and testing for sterile compounding
glove fingertip sampling procedure - no fewer than 3x before initially being allowed to compound AT LEAST ANNUALLY for low or medium risk TWICE A YEAR for HIGH RISK
only 1 license may be issued to a location
if a hospital is operating a class A pharmacy under its class C license it is not required to have a Class A license however it must follow class A rules for outpatient pharmacy including ratios of techs to pharmacists
Compounding aseptic containment isolator
if used for low - and medium - risk products it must be placed in an ISO Class 7 buffer area if used for high risk hazardous preparations, it must be placed in an area or room with at least ISO 8 conditions
When a pharmacy acts as a supplier ***5% rule
in addition to submitting a copy of DEA form 222 to DEA by mail or email the pharmacy must have a system to identify any suspicious orders, which, when identified, must be reported online to DEA's Suspicious Orders Report System (SORS)
Completing ACLS
initial 12 hours recertification 4 hours
TSBP does not need consent for:
inspecting a pharmacies financial records in the course of an investigation of a specific complaint
DEA needs consent for:
inspecting financial, sales and pricing data
change of ownership of Class A, C, F
inventory shall be taken on the date of change of ownership ****constitutes the closing inventory for seller and the initial inventory for buyer (also inventory with change of PIC)
TEXAS - storage of controlled substances
it is only REQUIRED in TEXAS for Schedule II Controlled Substances in Class C (Institutional) and Class F( freestanding medical care facility pharmacy) to be in LOCKED STORAGE
CE records
keep for 3 years
Class F freestanding emergency medical care facility
licensed by the Texas Department of State Health Services to provide emergency care to patients must have ONE PHARMACIST IN CHARGE who is employed or contracted at least on a consulting or part time basis
designated agent may be
licensed nurse PA pharmacist or any other individual the practitioner designates can also authorize a licensed vocational nurse to serve as a designated agent to call in rx's for NPs and PAs Practitioners must designate in WRITING each agent authorized to verbally communicate rx's
Texas Therapeutic Optometrist
limited to one 3-day supply of C III - V License # + "T" designation
Log of the unique initials or ID codes which will identify each pharmacist, pharmacy tech and trainee
log shall be maintained at the pharmacy for at least SEVEN YEARS (7) from the date of transaction
TSCA
mandatory e-prescription for controlled substances
Schedule III - V
may NOT be dispensed after 6 MONTHS from the date of issuance must be transmitted electronically unless one of the exceptions to mandatory electronic rx requirements is met or a waiver applies MAY be refilled as indicated on the original rx up to 5 times or 6 months unless it is for an opioid for acute pain (10-day supply with no refills)
Physician who is not part of a narcotic treatment program
may administer (not prescribe) narcotic drugs to an ADDICTED individual for NO MORE THAN 3 DAYS *until enrolled in a treatment program ** a hospital that is not part of a program may administer narcotics to drug dependent patients for detox or maintenance therapy if the patient is being treated in the hospital for a condition other than addiction
"TG" optometric glaucoma specialist
may administer and prescribe ORAL OR PARENTERAL DRUGS to treat glaucoma * in addition to what "T" can do **whereas "T" therapeutic optometrists may not prescribe oral or parenteral drugs - only tissue surrounding eyes
If an institution operates an outpatient pharmacy
there must be a pharmacist on-site when the outpatient pharmacy is open the outpatient pharmacy must also meet all Class A rules including the pharmacy to technician ratio
Library
may be hard copy or electronic** Laws and rules - Texas Pharmacy Act and rules, Texas Dangerous Drug Act and rules, Texas Controlled Substances Act and rules, Federal Controlled Substances Act and rules At least ONE CURRENT general drug information reference which includes drug interaction information if dispenses vet drugs, a general reference on veterinary drugs basic antidote information and phone number of the nearest regional poison control center
Permissive substitution
may dispense a generically equivalent drug or interchangeable biological product if: the product COSTS LESS than the brand name the patient does not refuse the substitution the prescriber has not prohibited substitution by a dispensing directive
APRN or PA C III - V
may not exceed 90 day supply DEA# required of delegating physician
Dangerous drugs
may only be dispensed by a pharmacist in a Class D pharmacy pursuant to a rx drug order
Fails NAPLEX or MPJE
may retake each examination 4 additional times (5 total) *after 5 times an applicant must meet additional requirements, including additional coursework, before being allowed to take the exams again
Class D pharmacy
may store and provide samples of dangerous drugs on the clinic's formulary that have been supplied to the clinic's practitioners from a manufacturer
Emergency refill
may use professional judgment in refilling a prescription for a drug other than a C-II the QTY prescribed DOES NOT exceed 72 hour supply **if the governor declares a disaster - and if notified by TSBP - the pharmacist may dispense a 30 day supply **tsbp permits dispensing the entire unit of use products such as oral contraceptives, inhalers, ophthalmic solutions **inform patient that the authorization of the prescriber is required for future refills and - the pharmacist informs the practitioner of the emergency refill - the pharmacist maintains a record of the emergency refill containing the information required to be maintained on a prescription - the pharmacist labels the refill as a prescription ****applies to C III - V drugs also
Texas HIPAA
more stringent training requirements also has specific rules on "Confidentiality" and "Patient Access to Confidential Records" TSBP rules require a pharmacy to respond to a request for CONFIDENTIAL RECORDS within 15 DAYS which is stricter than HIPAAs 30 days
Medium Risk
multiple individual or small doses of STERILE products are combined to prepare a product administered to multiple patients or one patient on multiple occasions or involves complex aseptic manipulations other than a single volume transfer > 3 products multiple doses batch Examples: TPN / filling reservoirs Room temperature: 30 HOURS Fridge: 9 DAYS Frozen: 45 DAYS
Texas law for pseudoephedrine
must be 16 YO product packaging - covered products (other than liquid including gel caps) must be either in blister or unit-dose packaging must have log book *exception for individual sales of a single convenience package of LESS THAN 60 MG of PSEUDOEPHEDRINE PHOTO ID required MUST SIGN Enter name, address, date and time of sale training www. deadiversion.usdoj.gov/meth/index.html Mail service: must confirm the identity of purchasers sales limited to 7.5 g / 30 days period
Written controlled Substance prescriptions
must be MANUALLY signed and DATED on the date issued Must contain: Full NAME and ADDRESS of the patient Drug name, strength, dosage form QTY prescribed Name, address, DEA NUMBER of the PRACTITIONER Additional requirements for controlled substances in TEXAS: 1. QTY PRESRIBED must be WRITTEN NUMBERICALLY AND as WORD Vicodin #20 (twenty) *if not written as a word, the pharmacist should call to verify the quantity 2. DATE of BIRTH or AGE of the PATIENT 3. PRACTITIONERS TELEPHONE NUMBER at their usual place of business 4. THE INTENDED USE unless the practitioner determines this is not in the best interest of the patient 5. written Schedule II prescriptions must be written on an OFFICIAL TEXAS PRESCRIPTION FORM ***2-4 are required for all prescriptions in Texas DEA does not allow pharmacists to pre-populate a controlled substance rx with all required information and then fax or electronically send the rx to a practitioner to be signed
Computer system
must be backed up MONTHLY
Class C pharmacy retrospective review
must be conducted within 72 hours if the hospital has a full-time pharmacist if the pharmacist has a part time pharmacist the drug regimen review must be conducted within 96 hours if the facility has an average daily census above 10 (>10) and within 7 days if the facility has an average daily census of 10 or fewer (</= 10)
Class F pharmacy - invoices of dangerous drugs and controlled substances
must be dated and initialed or signed by the person receiving the drugs
Pseudoephedrine Mobile Retail Vendors "flea markets"
must be in LOCKED cabinet no more than 7.5 g in 30 days
C-II Faxed
must be on signed written (paper) rx written on TSBP "official form" only in THREE SITUATIONS *oral only for emergency situations
Audit trail
must be provided within 72 hours
Pharmacists who compound sterile preparations or supervise personnel who compound sterile preparations
must complete 20 hours of instruction through either a college of pharmacy or an ACPE approved course AND complete on the job training at the pharmacy which cannot be transferred to another pharmacy unless the pharmacies are under common ownership
Exempted prescriptions *manufacturers may apply to DEA to exempt a product or chemical from certain provisions of the controlled substances act - labeling and inventory
nonnarcotic products containing small amounts of : PHENOBARBITAL BUTALBITAL CHLORDIAZEPOXIDE MEPROBAMATE *FIORICET: butalbital, acetaminophen, caffeine
Ephedrine Pseudoephedrine
not controlled under federal law
CE
must complete at least 30 CONTACT HOURs during the preceding license period (TWO YEARS) 1 contact hour must be pharmacy LAWS and RULES 2 contact hours must be related to approved procedures of prescribing and monitoring controlled substances **statutory requirement for anyone who has access to the PMP ONE TIME REQUIREMENT for all licensed healthcare professionals - not part of the 30 contact hours requirement - only count toward general CE requirements if it is also an ACPE accredited course 1 hour mental health awareness **ONE TIME REQUIREMENT
Facilities with 101 beds or more
must have ONE FULL TIME PIC who can only be PIC for ONE SUCH FACILITY may not serve as a PIC for a Class A or B pharmacy
Compounding pharmacies
must have a Class A prescription balance or analytical balance and weights which are subject to inspection by TSBP
Facilities with 100 beds or fewer
must have a PIC who may be employed or under contract as a consultant and may be part time one pharmacist may be PIC of no more than 3 such facilities or 150 beds ***a pharmacist may be the PIC of one facility with 101 beds or more and one facility with 100 beds or fewer as long as the total number of beds DOES NOT EXCEED 150
Preceptors
must have a current, active pharmacist license must have at least 1 year of experience or 6 months of residency training **must have completed THREE HOURS of preceptor training through an ACPE course ***must complete THREE HOURS of preceptor training EVERY 2 YEARS
Class C pharmacy
must have a pharmacist accessible at all times - although this may be provided though a telephone service that is answered 24 hours a day, a paging service, or a list of phone numbers where a pharmacist may be reached
Invoices
must have initials of pharmacist actual date of receipts records on the invoice in Class C ASC and Class F - invoices of dangerous drugs and controlled substances must be initialed by the PERSON actually receiving the drug *exempt
Compounded rx label
must have names of the principle active ingredients and a statement that the preparation has been compounded by the pharmacy all procedures shall be covered by WRITTEN SOP
Breach affecting <500 individuals
must maintain a log notify HHS ANNUALLY
Lost completed DEA form 222
must make another form along with a statement containing a SERIAL NUMBER and DATE of the LOST FORM and stating that the goods covered by the first order WERE NOT RECEIVED because the form was lost
Notification and CE requirements
must notify TSBP prior to engaging in DTM must complete at least 6 hours of CE ANNUALLY related to drug therapy
oral rx from APRN or PA
must provide delegating physician information AND DEA #
Patient medication records
must provide for the immediate retrieval of information for the previous 12 months to conduct a drug regimen review PIC must assure that a reasonable effort is made to obtain and record at least the following information: Name, address, telephone number Age and gender of the patient known allergies and chronic conditions or disease states other drugs pharmacist's comments relevant to drug therapy a list of all rx drug orders dispensed (new and refill) to the patient by the pharmacy during the last 2 years
Licensure by reciprocity
must provide proof of initial licensure by examination and that current license or any other licenses have not been suspended, revoked, cancelled, surrendered, or otherwise restricted must pass the Texas MPJE (75 is passing) Texas allows reciprocity from a state where a pharmacist obtained a license by examination or reciprocity
Administration of Epinephrine
must report such administration to the PCP within 72 hours from the time of administration
Reissuance, or Removal of Restriction on Licnese
must wait a minimum of 12 months
labeling requirements
name, address and phone number of the pharmacy prescription number - no smaller than 10 POINT TIMES ROMAN Date dispensed Initials or ID code of the dispensing pharmacist **not required if maintained in the computer system name of prescriber name of pharmacist signing a prescription drug order ** if applicable name of patient **if for an animal - the species of the animal and the name of the owner Instructions for us - no smaller than 10 POINT TIMES ROMAN QTY dispensed appropriate ancillary instructions if for a C II - IV drug the federal transfer statement ***federal law prohibits ***Federal transfer caution is NOT required for C-V drugs or dangerous drugs Name and strength of drug 10 POINT TIME ROMAN a BUD that is not greater than 1 year from date dispensed or the manufacturer's expiration date, whichever is shorter either the rx label or the written info shall contain the statement "Do not flush unused medications or pour down sink or drain" *unless on list for drugs not required to bear this statement (fentanyl) **not required for hospital or nursing home patient / institutionalized
change of pharmacy name
new license filed 10 days prior to change
Change of pharmacy LOCATION
new license filed 30 days PRIOR to change
Class C and Class G pharmacy
no ratio
Texas college / SOP program
no ratio for preceptors supervising pharmacist interns
Class E NONRESIDENT
not located in TEXAS nonresident pharmacies whose primary business is to dispense a rx drug or device under a rx drug order and deliver the drug or device to patients in Texas process a rx drug order for a patient in Texas or perform another pharmaceutical service as defined by Board rule *** a mail order pharmacy that is located in Texas would not have a class E license - it would have a Class A license ***** Individual pharmacists working in the pharmacy do not have to have a Texas license, but the PIC of a class E pharmacy must be a Texas licensed pharmacist
Electronic prescriptions
note "brand necessary" or "brand medically necessary" on the electronic prescription on an electronic rx for a MEDICAID patient, the practitioner must also MAIL or FAX a WRITTEN rx with the written dispensing directive to the pharmacy WITHIN 30 DAYS
Age or DOB required
on controlled substances in TEXAS
Agreed Board Order
once approved cannot be appealed
Canadian or Mexican
only WRITTEN prescriptions for dangerous drugs (NOT CONTROLLED)
PERPETUAL INVENTORY
only required for: SCHEDULE II controlled substances in Class C (INSTITUTIONAL PHARMACY) ALL controlled substances stored in a REMOTE LOCATION under the remote pharmacy rules ALL controlled substances in CLASS C AMBULATORY SURGICAL CENTERS (ASCs) ALL controlled substances in CLASS F pharmacy
DEA FORM 41
onsite destruction of controlled substances in a pharmacy required the NAME and NDC number of the drug STRENGTH DOSAGE FORM PACKAGE SIZE QTY of the controlled substances destroyed recording the METHOD by which the drugs were destroyed and TWO SIGNATURES of employees who WITNESSED the destruction ***because it is difficult to comply with all other laws including EPA requirements, most pharmacies do not use this method of destruction ***DEA FORM 41 is also used to document destruction of controlled substances that a pharmacy received as an authorized collector even though these drugs are not "stock"
Order for Epi auto-injector to be stored at specific types of entities
order must contain: name and SIGNATURE of the prescribing physician or other person name of the ENTITY to which the order is issued the QTY to be obtained and maintained under the order the DATE the order was issued
DEA form 222
ordering Schedule II controlled substances for each sale or transfer of C-II (except dispensing to ultimate user) only ONE item may be ordered on EACH numbered line orders for ETORPHINE HYDROCHLORIDE and DIPRENORPHINE must contain only orders for these substances the number of lines completed must be noted on the form name and address of SUPPLIER from whom the substances are being ordered must be entered must be SIGNED by the registrant and by the person being authorized to execute DEA from 222 registrant may authorize POA - does not need to be sent to the DEA
Out of state prescriptions
out of state, Canadian, or Mexican practitioners or practitioners in federal facilities the PRESCRIPTION must AUTHORIZE SUBSTITUTION (rather that prohibit it)
TSBP
permit emergency refills of C III -V under specific circumstances permit pharmacies to implement AUTOMATIC REFILL PROGRAMS for C IV - V **but not C III you may communicate C III -V verbally by a practitioner or their agent to a pharmacist ***technically is should only be done in an emergency BUT the TCSA does not require a pharmacist to verify that the rx is exempt from the requirement that it be submitted electronically TSBP has indicated that a pharmacist may dispense a C III -V under verbal prescription ***because TSCA technically requires an emergency for C III -V - the statute also requires that WITHIN 7 DAYS - the prescriber MUST PROVIDE AN ELECTRONIC PRESCRIPTION to the pharmacy ***but it may not be done because it is not required by the DEA
Class C-ASC
perpetual inventory of all controlled substances Invoices of dangerous drugs and controlled substances must be dated and initialed by the person receiving the drugs a pharmacist must conduct an audit by randomly comparing the distribution records with the med orders at least every 30 days drugs may only be supplied in prepackaged QTYs not to exceed a 72 hour supply
Class F
perpetual inventory of all controlled substances which shall be verified AT LEAST ONCE IN EVERY CALENDAR WEEK
Class F operational standards
pharmacy and storage are for rx drugs must be ENCLOSED and capable of being LOCKED only individuals authorized by PIC may enter the pharmacy or have access to storage areas for rx drugs shall have LOCKED STORAGE for C-II's in absence of pharmacist - only designated licensed nurse or practitioner may remove drugs from the pharmacy for immediate use
PREP ACT
pharmacy technicians with appropriate training were given authority to administer COVID 19 vaccinations irrespective of state laws and regulations this was extended to flu vaccines provided to adults 19 years of age or older in 2021 ***these authorities under PREP act are temporary unless state law is changed Texas law was not amended to make these authorities permanent **requires written protocol with a physician **services to patients <14 may be provided only if referred by a physician EXCEPT a pharmacist may administer a FLU vaccine to a patient over the age of 7 without physician-patient relationship Pharmacist certification requires an ACPE approved course which includes: BCLS certification 20 hours of CDC training 3 hours of CE every 2 years relating to disease states, drugs, and administration of immunizations or vaccines
New Rx drug order
prescriptions that have not been dispensed to the patient by the pharmacy in the SAME STRENGTH and DOSAGE FORM within the past year **information must be provided which the pharmacist deems significant Verbal and written information must be provided written information may be electronic (including email) if the patient has requested electronic communication and this request is documented must document initials or ID code of the pharmacist providing counseling either on the rx or in the computer system
Class G Central Prescription Drug Order or Medication Order Processing
primary purpose of processing prescription drug or medication drug orders on behalf of another pharmacy, a healthcare provider, or a payor CANNOT POSSESS, STORE, OR DISPENSE DRUGS but may perform the following: receive, interpret, clarify rx drug or med drug orders data entering and transferring of rx drug or med order information performing a DRR - drug regimen review obtain refill and substitution authorizations verify accurate rx data entry interpret clinical data for PA for dispensing perform therapeutic interventions provide drug information concerning a patients rx NO RATIO IN CLASS G PHARMACIES
OTC sale of DEXTROMETHORPHAN
prohibits OTC sale to those under 18 YO must require ID **does not apply to a prescription
unaccepted electronic order
purchaser must electronically link the statement of nonacceptance to the original order the original statement must be retained for TWO YEARS **neither a purchaser nor a supplier may correct a defective order **the purchaser must issue a new order for the order t be filled
Class A pharmacy
ratio 1:6 if pharmacy technician trainees - max 3 so if all pharmacy tech trainees 1:3
a collector that conducts a mail-back program may only accept packages that the collector made available - if they receive a package that they did not make available
they must notify the DEA within THREE BUSINESS DAYS of receipts
TRANSFERS
refills of a C-III - V may be transferred to another pharmacy on a ONE TIME BASIS if pharmacies share an electronic, real time, online data base of prescriptions - they may transfer up to the max number of refills only refills may be transferred DEA and TSBP DO NOT permit a pharmacy to transfer an ORIGINAL controlled substance prescription that has been received at a pharmacy but not yet filled at another pharmacy ***exception: an original electronic rx for a controlled substance, including a C-II, can be transferred to another pharmacy if both pharmacies have the capability to forward and receive the EPCS using an electronic sharing program ***some pharmacies don't do this or have the capability
Dispensers (pharmacies and practitioners)
register every 3 years with DEA *controlled substances
Extended intern
registered with the board who is no longer a student intern and other individuals in specific circumstances such as foreign pharmacy graduates or those seeking reissuance of a pharmacist license
Pharmacy Tech
renewal of registration requires 20 HOURS of continuing education every 2 YEARS including 1 hour of TEXAS LAW *maintaining certification is not required - just need to renew registration
License renewal
renewed BIENNIALLY in Texas (every 2 years) licenses expire on the last day of the assigned MONTH (birth month) "Timely receipt" - renewal application and fee received in the Board's office on the last day of the expiration month there is no grace period
Reporting loss of LISTED CHEMICALS *pseudoephedrine products
report to the DEA at the EARLIEST PRACTICAL OPPORTUNITY A WRITTEN REPORT must be provided within 15 DAYS and must include a DESCRIPTION of the circumstances of the loss ***DEA FORM 107 is used to report the LOSS
Written rx - TSBP
require QTY to be written as a figure and spelled as a word
Automated pharmacy dispensing systems
require continuous monitoring and tests accuracy at least every 12 months or when an upgrade or change is made to the system must operate under written policies and procedures must have a recovery plan for disasters or other interruptions *****FINAL CHECK 1. checking final product after the automated system has completed the rx and prior to delivery 2. a pharmacist verifying that any bulk stock drugs have been accurately stocked and the pharmacist checks the accuracy of the data entry of each prescription entered into the system - this requires that the system be FULLY AUTOMATED if this method is used - THE SYSTEM MUST BE TESTED FOR ACCURACY MONTHLY 3. automated checking device - confirms after dispensing but prior to delivery that the correct drug and strength have been labeled *using technology such as barcoding
TSBP rules
require that inventories (other than the INITIAL and CHANGE of PIC inventories) be SIGNED by the PERSONs taking the inventory and the PIC and that the signature of the PIC: be NOTARIZED WITHIN 3 DAYS of the day the inventory is completed *excluding Saturdays, Sundays and Federal holidays
Intended use
required in TEXAS on all prescriptions prescriber CAN opt out
Name & QTY of drug , practitioners telephone #
required on all prescriptions
Office use compounding for distribution to physicians, Class C pharmacies, or vets
requires a WRITTEN AGREEMENT with the practitioner or pharmacy must be labeled " For Institutional or Office use Only - Not for Resale" or "compounded product" for distribution to veterinarians
Pharmacist is off site
rule unique to Texas*** allows filled prescriptions to be delivered to patients in the pharmacy for up to 2 hours after the pharmacy department is closed (do not exceed 2 consecutive hours in a 24 hour period) may be useful in grocery stores or other locations where the rx department is closed but the rest of the store remains open
Dangerous drugs
rx medical devices rx drugs that are not controlled
Texas Medical Board does permit prescribing of controlled substances to family members / close personal relationship
to meet immediate needs defined as no more than a 72 hour supply
Daily hardcopy printout
shall be produced within 72 hours of the date the prescriptions were dispensed ***each pharmacist who dispensed or refilled a rx shall verify that the information is correct by signing and dating the hardcopy printout within 7 days from the date of dispensing pharmacy may maintain a daily logbook that pharmacists must sign daily instead of the daily hardcopy printout - but the computer system must be able to produce an "audit trail" within 72 hours
Class C with >/= 101 beds
shall be under the continuous ON SITE supervision of a pharmacist when the pharmacy department is open for services
To renew a license, a pharmacist who engages in compounding sterile preparations
shall complete 2 HOURS of CE RELATED TO COMPOUNDING if engaged in compounding LOW and MEDIUM risk preparations or 4 HOURS if engaged in compounding HIGH RISK preparations
Temporary use of DEA registration upon sale of a pharmacy
shall remain in effect no more than 45 days
DEA allow pharmacist to compound narcotic controlled substances C II - V
so long as the concentration of the final solution, compound, or mixture is NO GREATER than 20%
Order cannot be filled in its entirety, the supplier may fill the order in part
supply the balance within 60 DAYS
Automated dispensing
test accuracy: minimum of every 6 months
State scheduling authority for controlled substances
the COMMISSIONER of the Texas Department of State Health Services
OTC sale of C-V
the FCSA allow certain C-V products to be purchased from a pharmacy without a rx mainly cough suppressants products with codeine such as Robitussin AC and products for diarrhea containing small amounts of opium ALL CODEINE PRODUCTS REQUIRE AN RX IN TEXAS (even schedule V)
Reporting professional liability claims
the initial report is required WITHIN 30 DAYS of receiving the claim notice a follow up report is required WITHIN 150 days after disposition of the claim
License expired > 1 year
the license CANNOT be renewed
License expired for > 90 days but < 1 years
the licensee may pay a renewal fee equal to TWO TIMES the renewal fee and report the required # of CE hours
Two types of CSOS certificates 2. CSOS signing certificates
used for digitally SIGNING CONTROLLED SUBSTANCE ORDERS issued to approved REGISTRANT and POA applicants ***only given to a approved coordinator applicant if they hold a valid POA and has requested a signing certificate on their CSOS Certificate application
Auto refill
used for refills of dangerous drugs and Schedule IV and V controlled substances
Methadone
used for severe pain and in the detox and maintenance of narcotic addicts in registered narcotic treatment programs any pharmacy can stock methadone, it can only be LEGALLY DISPENSED as an analgesic DEA has requested manufacturers to restrict sales of METHADONE 40 MG TO HOSPITALS and NARCOTIC TREATMENT CLINICS ONLY *not allowed to sell to retail pharmacies Narcotic Treatment Center must be registered with the DEA and also must be certified by the Center For Substance Abuse Treatment (CSAT) within the SAMHSA of the U.S Department of HHS in TEXAS must also obtain a license issued by the TEXAS DEPARTMENT OF HEALTH AND HUMAN SERVICES Narcotic treatment facilities may administer and dispense *NOT PRESCRIBE* narcotic drugs for detox Short term --> decreasing doses for a period not to exceed 30 days long term ---> decreasing doses in excess of 30 days not in excess of 180 days
Two types of CSOS certificates 1. CSOS Administrative Certificates
used to digitally sign communications with DEA as well as with other participants in the CSOS community issued only to CSOS COORDINATORS NOT VALID for electronic ordering
Pharmacy tech trainee
valid for 2 years and is NOT renewable
FAX
valid for C-III - V under federal law but they technically must meet the emergency requirement under the TSCA **must have original signature **handled same as verbal
Class C-ASC if the facility has a part-time or consultant pharmacist
verify withdrawal of ALL DRUG drugs at a reasonable interval, at least once every calendar week
Class F Full time pharmacy
verify withdrawal within 72 hours for controlled substances but at least ONCE EVERY CALENDAR WEEK for dangerous drugs
Emergency rooms
when a pharmacist is on duty in the facility, any drugs dispensed for outpatient use, including to emergency room patients, must be dispensed by a pharmacist when a pharmacist is not on duty, dangerous drugs and controlled substances may be supplied to patients admitted to the emergency room under the following conditions: only drugs on an emergency room drug list drugs are supplied in PREPACKAGED QTYS not to exceed a 72 hr supply drugs are prepackaged by the pharmacy department and at time of delivery the label is completed by the practitioner or nurse with: name address telephone # of facility date supplied name of practitioner name of patient directions for us unique identification # (prescription number) brand name or generic name and strength QTY supplied PHARMACISTS SHALL VERIFY THE CONTENTS OF THE EMERGENCY ROOM DRUG LIST RECORDS at least ONCE EVERY 7 days
Schedule II prescriptions
when issue in writing: must be on Texas official rx form signed by the practitioner VERBAL prescriptions for C-II drugs are NOT PERMITTED except in EMERGENCY cannot be refilled there is no federal time limit under TEXAS LAW a C-II must be filled within 30 days after the date issued or the first date authorized to fill DATE ISSUED = DAY ZERO
Notify physician - vaccines
who issued the protocol: within 24 hours of administration the primary care physician of the patient must be notified with FOURTEEN DAYS (14 days)
change of pharmacist employment
within 10 days
change of pharmacist name or address
within 10 days
permanent closing of pharmacy
within 10 days AFTER closing
Transfer
within 4 business hours of a request
Official C-II prescription
written: must be on a Texas Official Prescription Form *issued by TSBP and contain security features: UNIQUE CONTROL # A PANTOGRAPH - that reveals the word "VOID" when copied THERMOCRHOMIC INK on the front with the symbol "RX" that disappears briefly when rubbed A WATERMARK of the SEAL OF TEXAS that is visible from either side in regular light
Display of Pharmacy License
you cannot copy your original license or renewal certificate but you may copy your "pocket license" card
License inactive status
you must still pay the license renewal fee to activate your license, you must pay a fee and meet specific CE requirements
