PharmLaw 4

smoore020390's version from 2015-09-07 17:16


Question Answer
To qualify as a CV, diphenoxylate and atropine 2.5mg of diphenoxylate with not less than 25mcg of atropine per tablet
Individuals who may lawfully purchase, possess, or transfer CS in absence of DEA registration Agent/employee in usual course of business (RPh, practitioners of institution), common carrier in usual course of business, and the user
To operate a community pharmacy in NYS must be registered with DEA . Pharmacists act as agent
To operate an institution in NYS must register with DEA and BNE!
CS DispenserPrescribers, pharmacies, and hospitals (includes prescribing, administering, packaging, labeling, and compounding)
How many years need to keep CS records?5 years per NYS! (Federally only 2)
What are appropriate records of receipt for CS?DEA 222/CSOS and invoices for CIII-V
CS Inventory DocumentsMust be held separately from all other records!
Filing CS RxsNeed to file CII separately from CIII-CV
What is an illegitamate purpose for an Rx? Office use, maintenance of addiction, amphetamine for weight control


Question Answer
Written Rx RequirementFor NYS law all CII-CV must be signed and dated, in ink, type or indelible pencil.
What can be added to an rx with MD permissionDEA #, directions, code, MDD, strength, refills. If only editing, can change dosage form with MD permission.
What can be added to an Rx without MD permission?Patient info - gender, age, address. MD info (does not have to be added if info readily available to RPh) - telephone, state license, and profession
What can never be added to an Rx?Patient name, medication name, date rx written, provider signature, quantity - BUT CAN edit quantity with MD permission
Emergency CII Rxs Need to beExactly the same as what was dispensed/called in by MD and needs to say "Authorization for Emergency Dispensing (AFED)".
What should Rx endorse on follow up hard copy of oral CIIThe date of delivery of AFED and RPh signature
Rules for filling faxed CII RxsFor non-emergent Rxs. Must have same f/u with hard copy in 72 hrs (only NYS). May issue 30 day supply if contracted with RHCF/hospice. Must note on Rx that it is for hospice/RHCF pt. Also for compounded parenteral products. Still need hardcopy in 72 hr
Must file CS information with BNE no later than24 hours after delivered.
What should be filed with BNE if no CS dispensed?Report zero. Cannot be any later than 14 days after most recently reported dispensing CS
What schedule are BZDs in NY?CIV


Question Answer
Can BZDs have refills in NY?No! Even though technically a CIV, no refills in NYS
When can we partially fill CII Rxs?Only if unable to supply! not by request of pt. Must supply remainder within 72 hours or Rx invalid. Or if RHCF/terminally ill
What are rules for partial filling of CIIs in RHCF or terminally ill patients?Have up to 60 days to fill remainder of drug when partially fill. Need to document reason for partially filling on rx (term ill or RHCF) and on back of Rx, sign, qty dispense, qty remaining and date
Can CIII-CV Rxs be faxedIn NYS, still only for hospice and LTC patients! Still need hard copy within 72 hours!
Are faxes accepted for any CS Rx for any normal community pt ?NO! For CII-CV only for hospice RHCF pts and still need hard copy in 72 hrs
Can CIII-CV Rxs be partially filled?Yes! Record like a refill. Total quantity dispensed has to be less than 30 day supply.
Are oral CIII-CV Rxs acceptable?Not really - diff vs federal law. Only for limited supplies. Must be called in by actual provider. For all Rxs CII-CV can give 5 day supply for oral Rx, except with CIV-nonBZD, max 30 days or 100 dosage units.
What has to be recorded on back of hard copy for oral Rxs (CIII-CV)?"Follow up Rx to oral order, pharmacy Rx number XXXXX, oral order filled on XXXXX, follow-up Rx received on XXXXXXX".
For a CIII-V Rx 30 day supply with 2 refills, could MD authorize additional refills?YES! As long as within 6 months and pt has received <5 refills.
Can any controlled substances have refills transfered?NO! Per NYS Law. Federal law allows for 1 time transfer of controlled substances.
Which label(s) must be included on CS CII-CIV Rx?Caution: Fed law prohibits the transfer of this drug to any person other than the pt for whom it is intended" and "controlled substance: dang unless used as directed"
Which label(s) must be included on CS CII-CV?Controlled Substance - dangerous unless used as directed


Question Answer
How should all CS scripts be endorsed?Signature, date of filling, Rx number. Refills also must be endorsed on back.
When reporting CS dispensing activity to BNE, what info must be reported?All relevant rx info including, serial number of Rx!
When reporting CS to BNE, what should serial number be if out of state Rx?eight "z"s
When reporting CS to BNE, what should serial number be if telephone order?eight "9"s
In an institution setting, oral medical orders must be signed by practitioner within48 hours
When may a class 3a institution be allowed to have bulk stocks of CS?Nursing home that is "physically integrated" with a class 3 facility, class 3a with a limited pharmacy on-site, and ADC's
To destroy CS in NYS does BNE have to be contacted or just DEA?Yes! must contact BNE must approve with written request. 2 forms DOH 2340 is request for destruction and form DOH-166 is controlled substance inventory. Must request at least 3 weeks.
After disposing of CS in NYS, what must be submitted to BNE?Must complete section II of DOH-2340 and return within 10 days of disposal!
How long must records of disposal of CS in NYS be kept?5 years
What are the federal laws for transferring CS refills? Are they valid in NYS?Fed law allows for 1x transfer of CS refills where original Rx then becomes void. NOT permitted in NYS!
What must pharmacies report in NY if significant theft or loss?DEA form 106 AND DOH 2094.