Law 5

vitohuxo's version from 2016-05-18 13:58


Question Answer
to obtain controled substances need apharmacy license, pharmacy controlled substance license, and DEA registration
what form is used to order schedule 2 drugsDEA 222 form. also use anytime move a schedule 2 other than dispense!
how long does a wholesaler have to fill a schedule 2?60 days
what must you have in order to sign DEA 222?cs license and DEA registrant...must get power of attorney if not the DEA registrant (they must have cs license too in order to sign)
paper schedule 2 order form each pharmacy provided with ___ books and each book has _________ forms6 books with 7 forms. each order form has a serial number
controlled substance invoicesmust document actual number packages received and date received. only a pharmacist can initial the invoice.
if a supplier refuses to fill DEA 222 form then what happensissues a statement order not accepted...attaches statement to copy 1 and 2 (normally goes to DEA end of month) and purchaser attaches this to copy 3. purchaser needs to retain in schedule 2 files.
electronic DEA 222 keep records electronically for _________ years2 years
schdule 3-5 ordering invoicerecord date drugs received confirm order accurate and initial the invoice
disposition (move) of controlled substancestransfer (pharmacy, physician, supplier or manufacterurer, reverse distributor), destruction, theft or loss, prescription
if transfering to another registrant pharmacy closing or selling then who issues DEA 222 form?the receiving registrant issues to the pharmacy closing.
transfer of schedule 3-5 drugs pharmacy closing to another registrant=• Transfer of Schedule III-V substances must be documented in writing (invoice) to show: o Drug name, dosage form, strength & quantity o Date transferred o Names, addresses and DEA registration #s of the parties
on the day controlled substances transferred pharmacy closing what must happen?complete inventory must be taken. not neccessary send copy to DEA. maintain all records of transfer for 2 years
Transfer to Supplier, Manufacturer, Pharmacy, Physician, or other licensee controlled substances• Must maintain a written record showing: o Date of the transaction o Name, strength, form and quantity of the controlled substance o Supplier’s or manufacturer’s name, address, and DEA # o Pharmacy name, address and DEA #
transfer for disposal (destruction) = transfer to reverse distributor....must be licensed?licensed by state michigan as wholesaler and controlled substance license and DEA registration.
DEA 41 formfor destructing controlled substances. if you transfer to reverse distrivutor they fill this out
reverse distributor sched 2 drugs they send pharmacyDEA 222 form.
reverse distributor sched 3-5 drugs send pharmacy.nothing. the pharmacy documents in writing: o drug name, dosage form, strength, and quantity o date transferred (invoice created) o Names, addresses and DEA numbers of parties involved in transfer
if there is a theft or significant loss then need notify DEA withinone business day- notify local DEA in writing and DEA must be notified directly.
not significant loss of CS then need to do what?fill out DEA 106 form and file with board of pharmacy and place original record in file at pharmacy. state requires reporting of any loss.
always report a theft usingDEA 106 form to DEA electronically
DEA-106 is for reporting any theft or loss of controlled substances. Do not use this form if:You have not previously registered with the DEA 2. The theft or loss you are reporting is not of a controlled substance; or 3. You want to correct minor inventory shortages.
The paper DEA Form 106 must include the following information:o Name and address pharmacy o DEA registration number o Date of theft or loss o Name and telephone number of local police department notified o Type of theft (night break in, armed robbery, etc.) o List of identifying marks, symbols, or price codes (if any) used by the pharmacy on the labels of the containers o A listing of controlled substances missing, including the strength, dosage form, and size of container (in milliliters if liquid form) or corresponding National Drug Code numbers
theft or loss requirements michigan rule• Within 10 days following the discovery of a theft or loss of any controlled substance • Use a DEA-106 form or equivalent document • Whether or not reported to the DEA • Michigan requires reporting of any loss no matter how significant
in transit loss CS from supplier or central fill• If all or part of a shipment from the supplier disappears, or never reaches its intended destination - the supplier is responsible for reporting loss • If pharmacy has signed for or taken custody of a shipment-it’s discovered after that point-the pharmacy must report loss
what if broken tab?Then reverse distributor. not count as loss.
what if breakage or spill not recoverable?document in inventory records two individuals witness must sign.
pharmacy employee cannot be convicted of felony related to CSmust have waiver approved exception from DEA before hiring
\Records of controlled substances dispensed (i.e., prescriptions) • Prescriptions keep 5 years from last date of dispensing, after 3 years an electronic duplicate of original can become the original
off site (central) records can beFinancial and shipping records (invoices)
readily retrievable definitionReadily retrievable" means a record which is kept in such a manner that it can be separated from all other records within 48 hours and in which a listed controlled substance shall be marked with an asterisk, redlined, or in some other manner be visually identifiable apart from the other substances listed in the record.”37
to do central record keeping must• Notify the nearest DEA Office by registered or certified mail – Michigan doesn’t state how to do it but need to notify them in writing. begin maintaing cnetrally 14 days after notify DEA. Central Recordkeeping notification must include: • Nature of the records to be kept centrally • Exact location where the records will be kept • Name, address, DEA registration # and type • Records maintained in a manual, or computer readable form o If records kept in form requiring special equipment or special coding – provide reading equipment or code to the DEA
if keeping central records and dEA send request send to primary location then how long have?48 hours
michigan requires a CS inventory annually when?april 1 to june 30 • Licensee to sign and date the inventory • Pharmacy printed name, address and DEA number on inventory • A copy of inventory mailed to department/Board • No requirement to send a copy to the DEA
for a pharmacy to import CS from another country must beregistered as importer DEA
hiaght act of 2008- internet pharmacies• Valid prescription required to dispense controlled substance via Internet • Patient practitioner relationship must exist • Include one medical evaluation carried out in person • Modify DEA registration if “online pharmacy” • Monthly reporting to DEA if meet thresholds
how to tell if internet pharmacy legit?Verified Internet Pharmacy Practice Site (VIPPS) seal issued by NABP