MPJE sections A-C

what does the preprinted info on the 222 form have

1. name, address, and dEA number of pharmacy 2. serial number of order form and date issued by DEA 3. schedules authorized to be dispensed: 2 (narcotic), 2N (non-narcotic), 3, 3N, 4, 5

what do we write on the CII after filling

1. we sign, date, and enter the prescription number 2. have to add pharmcy name, street address, city, state, and zip, phoen # with area code, pharmacy DEA (can be stamped)

how can you transfer between pharmacies for CIII-CV for refill purposes

1. you can only transfer these between pharmacies one time 2. Exception for pharmacies sharing a real-time, on-line database.

when do you take inventory of newly scheduled drugs

on the day it was scheduled

On Schedule II-IV drugs, what will be written on the label

"Caution - Federal Law prohibits transfer of this drug to any other person other than the patient for whom it was prescribed" (not requred on a CV)

"carrying out" defined

"carrying out" of a prescdirption by signing a script that is pre-signed by the physician (which has both signatures)

what are the special warnings for ipecac syrup

- a. boxed and in red letters must say "for emergency use to cause vomiting in poisoning. before ususing, call physician, the poison prevention center, or hopital ER immediately for advice" b. must appear "Warning: Keep out of reach of children. do not use in unconscious persons" c. the dose of the med must appear. the usualy dose is 1 tbl in individuals over 1 year of age d. may only be sold in 1 oz. containers e. note difference between fluid extract and syrup: fluid extract is 14 times as potent as syrup

retail sales limits

1. 3.6 mg of base product per day and 9 g of base product per 30 days and has to be 16 years or older 2. the amount of base product varies depending on the salt form of the drug (pseudoeph HCL vs. Pseudoeph sulfate) 3. many states have sales limits per transaction rather than per day or 30 days 4. mail service limits to 7.5 g per 30 days

prescriptions from out-of-state preactitioners (not including Mexico an dCanada)

1. CII's - Texas pharmacies can only fill Schedule II controlled substnaces from a practitioner in another state if: A share of the pharmacy's business involves the dispensing and delivery or mailing of controlled substnaces or the prescription is issued by a prescribing practitioner in the ordinary course of paractice and the script is filled in compliance with a written plan provideing how it will be filled and the plan must be submitted by the pharmacy to the Director of DPS and approved by the Director in consultation with the TSBP 2. CII-CV - Texas pharmacies can fill from out of state if valid written, oral or telephonically or electronically sent. (does not include NP's or PA's from out of state)

how to order electronically for CII's

1. DEA allowed for electronic orders starting My 31, 2005 2. The Controlled Substances Ordering SYstem (CSOS) allows electronic orders based on digital certificates issued by the DEA certification authority. (equivalent to 222 form) 3. A DEA registrant must appoint a CSOS coordinator who will serve as that registrant's recognized agent regarding issues 4. the digital certificate with its extension data must be attached to each order when the order is transmitted to the supplier

to apply for registration and to renew you have to

1. DEA registrations are issued contingent upon meeting requirements and getting state licenses 2. for a pharmacy, first need pharmacy license fromt eh state board of pharmacy and in TExas, a controlled substances registration from the DPS 3. the DEA registration period for dispensers is for a 3 yrs. for manufactureing, and distributing is for 1 yr. the DPS registration period for all is one year 4. a renewal registration form is mailed to the pahrmacy w/i 60 days of expiration 5. if renewal is not received 45 days b4 exp, contact DEA in writing

what are the special warning requirements for OTC products in FDCA (1-3)

1. FD&C Yellow NO. 5 (tartrazine) and NO. 6 - must disclose presence and provide warning in "precautions" section of label that may cause allergic rxn in certain susceptible persons 2. Aspartame - must contain warning in "precautions" section of labeling to the following effect: Phenylketonurics: Contains phenylalanine _mg per_ (dosage unit) 3. Sulfites - prescription drugs containing sulfites (preservative) must contain an allergy warning int he "warnings" section of the labeling

rules on filling and refilling OTC drugs on prescription (3)

1. FDA labeling requirements are not necessary for OTC drugs filled pursuant to a prescription since the prescription label satisfies the FDA labeling requirements. any other situation regarding OTC drugs would require FDA labeling 2. there are rules on when you need authorization to fill and refill OTC prescriptions: a) if an OTC prescription calls for a dosage different than that recommended on the label of the manufacturer's container b) if the OTC has a prescriber's refill instructions, the pharmacist must follow them 3. Refill authorization is not required for an OTC prescription after the prescription has exp and the pharmacist sells the OTC in its original container. BUT, if the OTC drug is filled as a prescription it is deemed a prescription drug and, thus, the prescription must be valid and in date.

what are Medication Guide requirements (3)

1. FDA requires that med guides are dispensed to pts with some products that are determined to pose a serious and significant public health concern 2. must be written in standard format and laymens terms. manufac, must obtain FDA approval before distributing med guides and that enough are given to pharmacies 3. med guides are required to be provided when these products are dispensed for outpatient use and are for new and refills

when is there an exception for official prescription from for a CII

1. Hospital inpatient med orders that include pts admitted to a hospital, hopital clinic, hopital ER, licensed ambulatory surgical center, surgical suite in a dental office, or veterinary medical school 2. hosp inpatients requiring an emergency quantity of a CII drug upon release from the hopsital; limited to a 7 day supply, must be in appropriately-labeled container, must be dispensed by the hopital pharmacy while the pt is still admitted 3. a CII from a life flight helicopter 4. inmate 5 animals to an animal hospital 6. therapeutic optometrists administering topical cocaine as permitted under the Texas Optometry Act 7. Prescirptions form Out-of-state practitioners but only if the pharmacy has submitted a plan to DPS which has been approved by DPS and TSBP

what can you not change on a CII

1. name of the patient 2. name of the drug 3. name of prescribing physician 4. date of the prescirption (if there is a change makde verbally, document the name of who granted it and the pharmacists initials

what are the exceptions to the delivery of prescriptions by mail

1. Noncontrolled (Dangerous Drugs) may be mailed by the physician or pharmacist to the user but they can't be alcoholic beverages, poisons, or flammable substances. but, highly toxic substances may be sent by manuf to pharmacist or physician 2. Controls (CII-V) may be mailed if a. the container is properly labeled b. the outer wrapper where the prescription is placed must be free of marking that indicate the contents (no pharmacy name) c. no markings on package to indicate its contents 3. mailing controls to other registrants as long as the control is put in a plain outer container

what are the types of drugs covered under the FDCA

1. Prescription - Human and Animals 2. OTC 3. Controlled substances

OTC drug rules under the FDCA (3) that allow it to be OTC

1. Proprietary or patent - OTCs that are labeled and advertised for consumer self-use, usually marketed under a trade name 2. defined as drugs recognized among experts to be safe and effective for self use and admin 3. must be labeled with directions for the layperson that indicate their safe and effective use

manufacturer's labels must include:

1. name and address of the manufacturer, packer, or distributor 2. accurate statement of the quantity 3. generic name and proprietary name 4. quantity of the ingredients (i.e. 0.25 mg per tablet) 5. adequate info for use (package insert) 6. adequate warnings against use where dangerous 7.expiration date

Prescriptions Drugs exemptions covered under the Federal Poison Prevention Packaging Act (1-5)

1. SL nitroglycerin 2. SL and chewable isosorbide dinitrate in dosage strengths of 10mg or less 3. erythromycin ethylsuccinate tabs in packages of no more than the equivalent of 16g or equivalent of erythromycin 4. erythromycin ethylsuccinate granules for oral suspension containing not more than 8 g or equivalent of erythromycin 5. anhydrous cholestyramine in powder form

Prescription - human and animals - restrictions under the FDCA (4)

1. a drug which is habit-forming, toxic, or having a potential for harm or the New Drug Application (NDA) limits its use to under the supervision of a physician 2. label for human drugs must now provide at min the symbol "Rx only" 3. Veterinary products are required to be labeled "Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian." 4.certain products in the same drug class may be either prescription or non-prescription depending on the product. ex. are insulin products

rules for delivering controlled substances

1. a pharamcist may permit the delivery of a controlled substance tot he person or address of the person authorized on the prescription to receive the control if it is an authorize delivery person, the pharmacist knows the person, intern or by mail 2. the pharmacist shall retain record of the name of the person delivering or the mailing address to which delivery was made 3. pharmacist can permit delivery of control wihtout first requiring ID of the person if it is an emergency and drug is needed for immediate well-bing of the patient (keep record of name, address, and date of birth or age of person)

What are some situations in pharmacy practice that MAY require the pharmacy to register with the FDA and comply with FDA regulations, inspections, and CGMPs (4)

1. a pharmacy in hospital A repackages drug products for its own use as well as that for hospitals B and C (have to be under same ownership) 2. a pharmacy chain repackages and relabels quantities of drug products from the manuf original commercial containers for shipment to the individual stores 3. similar repackaging and relabeling conducted by individual pharmacists as members of an informal buying group (co-op) 4. if actually manufacturing a drug product

how do you distribute controlled substances to ambulances or EMS units (not affilited with the hospital)

1. a pharmacy may distribute controls to private and public ambulances or EMS units if the ambulance/EMS service secures the services of a consulting physician to order controlled substances. 2. the consulting physician must be registered by DEA/DPS at the central office location of the emergency vehicle

what are the rules with writing from methadone and narcotic dependence

1. a physician may prescribe methadone or any other narcotic for a pt for analgesic purposes only 2. narcotics prescripbed for detox or maintenance is permissible by a narcotic treatment program registered with DEA, FDA, and licensed in Texas by teh Texas Commission on Alcohol and Drug Abuse and possessing a permit 3. maintenance tmt means the dispensing, for a period in excess of 21 days 4. short-term detox means the dispensing, for a perioid not in excess of 30 days or a narcotic in decreasing doses 5. long-term detox means for a period in excess of 30 days but not in excess of 180 days in decreasing doses 6. only four individuals emplyed by the narcotic tmt program can dispense or admin narcotics to pts 7. a hospital that has no narcotic tmt program on the premises or a physician who is not part of a tmt program may administer narcotics to a dreg dependent individual for either detox or maintenance if being treated for a condition other than the addiction 8. a physician who is not part of a narcotic tmt program may administer (not prescribe) narcotic drugs to an addict for no more than 3 days to relieve acute withdrawal symptoms while they make arrangements to enroll the person in a tmt program.

OTC drug lables must have what 6 things

1. a principal display panel, including a statement of identity of the product 2. name and address of manufacturer, packer, or distributor, 3. net quantity of contents 4. cautions and warning needed to protect user 5. adequate directions for safe and effective use (layperson) 6.conent and format of OTC product labeling in "Drug Facts" panel format

what was Ross Perot's "Texans' War on Drugs"

1. a required triplicate prescription form for all schedule II prescritions, and 2. reporting to DPS of all control prescriptions dispensed by pharmacies within 15 days of the last day of the month in which the prescription is completely filled (the computer system does this for us) 3.the intent of the legislation was to reduce drug diversion of schedule II controls from four sources

Separate registrations

1. a separate registration is required for each physical locations where controls are manufactured, distributed, imported, exported or dispensed 2. each pharmacy must have its own DEA registration even if owned by same person Exception: satellite pharmacies w/i a hospital 3. a clinic or ambulatory surgical center that is at a different physical location must obtain a separate DEA registration 4. only one is needed for a hosp and its pharamcy, but if it has a separate registration from the hospital, all drug distributions would be between two registrants, requiring DEA order forms or invoices 5.individual practitioners that register at one place but work at another doesn have to register at both unless they maintain, admin, or dispense then at another location then msut register there as well, a separate DEA is neede for each state

define what "carrying out" or "signing" a prescirption drug order at an alternate site means

1. a site where services similar to the services provided at the delegating physician's primary paractice site are provided and 2. located w/i 75 miles of the dr.s primary practice site

What is the format of OTC product labeling in "Drug Facts" panel (8)

1. active ingredients 2. purpose 3. use(s) - indictions 4. warnings 5. directions 6. other information 7. inactive ingredients 8. Questions? followed by telephone number

how do you confirn a DEA number

1. add 1st, 3rd, and 5th digits 2. add 2nd, 4th, and 6th digits and multiply the sum by 2 3. add the sum of A and B above, and the last digit of the sum should correspond to last digit of the DEA number

if compounding codeine with cherry syrup what schedule would it be

CII because the cherry syrup is not therapeutic and codeine can be recovered in pur form (any straight narcotic, regardless of strngth is CII).

what do you do when an order is recieved

1. agent must fill out on the retained copy 3 of the DEA order form: the number of packages received, date recieved, and a pharmacist to verify that controlled substances listed on supplier's invoice were actually received by recording his/her initials and the actual date of receipt on the invoice

who are exempt from registration requirements with controls (7)

1. agent or employee of a registrant, if acting in usual course of business like a pharmacist, or tech 2. an individual practitioner who is an agent of another practitioner registered to dispense controls 3. a practitioner who is an agent or employee of a hospital or other insitution may, admin, dispense, or prescribe controlled substances under the registration of the hospital which is registered (have their individual ID's from the hospital) 4. officials of the US gov, like air force etc. can, but in texas, they can't write CII's for pts to fill off base if practitioners are not registered in Texas. (A CII can be written on a blank and filled on base, but not off base) 5. Federal and state law enforcement officials 6. oceans vessels and certain air carriers 7. individuals possessing a lawfully obtained controlled substance for personal use

When are emergency oral prescriptions for CII's allowed

1. an Emergency situation is one where immediate admin of the drug is necessary for the proper tmt of the pt, no appropriate alternative tmt is available including admin of a drug which is not a CII, and it is not reasonably possible for the dr to provide a written script to be presented to the person

examples of errors on the 222 form

1. any alterations, erasures, or changes 2. forms with a calendar date older than 60 days

define drug

1. articles recognized in an official compendium - U.S. Pharmacopeia/National Formulary (USP/NF) 2. articles intended for use in the diagnosis, cure, mitigation, tmt, or prevention of disease in man or animal 3. articles (other than food) intended to affect the structure or any function of the body of man or animal (if it changes the biological or chemical function of the body) 4. articles intended for use as a component of the above

when is Partial filling of schedule II's allowed

1. balance must be dispensed w/i 72 hours of the first parital 2. not on face of prescirption the quantity supplied 3. if balance can't be dispensed w/i 72 hours, no further quantity may be dispensed, and pharmacist MUST contact practitioner to get a new prescription 4.patients in LTCFs and terminally ill pts can have a script partially filled repeatedly as long as they keep a running tally of how much they have dispensed, verified for terminally ill pt, and must notate on script "terminally ill" or "LTCF patient". valid for up to 60 days

what is the Ryan Haight Online Pharmacy Consumer Protections Act of 2008

1. bans delivery, distribution or dispensing of controls over the internet without a "valid prescription" - a prescription that is issued for a legitimate medical purpose in the usual course of medical practice, by a a practitioner who has conducted at least one in-person medical evaluation of the patient 2. requires an online pahrmacy to provide 30 days notification to the US attorney general and state board of pharmacy where the online pharmacy plans to offer to sell controls 3. creates website design requirements 4. increases penalties for any unlawful distributors and dispensers of controlled substances

anabolic steroids in texas

1. can be dispensed, prescribed, delivere or admin by a practitioner for a valid medical purpose and in the course of professional practice

how do you use a 222 form

1. can be used to order from suppliers, transfer CII's between other registrants 2. triplicate copies: copies 1 and 2 must not be separated and must be sent to supplier. copy 3 remains in the pharmacy 3.only one item per line (must have # of packages, size of packages, name of drug, strength, and dosage form) 4. each form has 10 lines, pharmacist fills out the number of lines filled at the bottom of form 5.need to fill in supplier name, address, date and sign 6. date and sign-must be signed by individual who signed most recent DEA registration application or individual with POA 7. no erasures or alterations are permitted; use permanent ink or typewriter 8. unaccepted and defective order forms returned by supplier

what things does the FDA considering in determining whether to initiate action on a compounding pharmacy (1-5) of 9

1. compounding of drugs anticipating in receiving prescriptions except in very limitied quantities 2. compounding drugs withdrawn or removed from market for safety reasons 3. compounding drugs from bulk active ingredients that are not components of FDA approved drugs 4. receiving, storing, or using drug substances without first obtaining written assurance from the supplier that each lot of the drug substnace has been made in a FDA registered facility 5. receiving, storing, and using drug components not guaranteed or otherwise determined to meet official compendia requirements

where do the copies of the 222 form go

1. copy 1 - retained by supplier (whoever is providing the drugs) 2. copy 2 - sent to supplier to divisional DEA administrator 3. Copy 3 - retained by pharmacy (in separate file or attached to CII invoices)

more specifically, what did the Durham-Humphrey amendments provide (3)

1. created the OTC and prescription drug categories 2. how prescription drugs must be dispensed 3. drugs dispensed on are exempted from most of the manufacturer's labeling requirements

what can out of state PAs and Advance Practice Nurses prescribe

1. dangerous drugs - can be filled in Texas, but the PA or APN must have prescriptive authority for these drugs in their own state 2. controls - these can't be filled in texas

what do you do if order forms mailed by pharmacy to supplier are lost

1. execute another order form and include a statement to the supplier with: serial number of lost form, date of order, list of unreceived drugs 2. send upplier a new order form with the above statement 3. file copy 3 of new DEA order form and statement with Copy 3 of original order that was lost

how do you return CII substances to supplier

1. for cII's the wholesaler or distributor issues a DEA order form to the pahrmacy, keeps copy 3 of DEA order form 222, and supplies pharmacy with copies 1 and 2 of DEA order form 2. date containers shipped are recorded by the pharmacy on copies 1 and 2. copy 1 retained by pahramcy and copy 2 is sent to DEA by end of the month (the person recieving the drugs always fills out the 222)

what is a physician's authority to delegate the carrying out or signing of a prescription is limited to;

1. four PAs or APNs practicing at the Dr. primary practice site or alternate site 2. pts with whom the physician has established a relationship 3. the Texas Medical Board may rant a waiver to allow more than 4 PAs or APNs under certain conditions

all CII's have to have what 10 things

1. full name and address of the patient 2. the drug name, strength, and dosage form 3. the quantity prescribed 4. the name, address, and dEA number of the practitioner 5. if for a schedule II prescription to be filled at a later date, the earliest date on which a pahrmacy may fill aprescirption 6. quantity must be written out numerically adn as a word 7. date of birth or age of pt 8. the practitioner's DPS (an intern or residen tmay use an insittution or hospital's DPS number followed by a unique suffix IDing the intern) 9. the practitioner's telephone number 10. the intended use of the drug unless the practitioner determine sthe furnishing of this info is not in the best interest of the patient

8 things of an adulterated drug

1. has any filthy, putrid, or decomposed substance 2. been prepared, packed, or held under unsanitary conditions where it may have been contaminated 3. maniufacturedid not conform with Current Good Manufacturing Practices (CGMPs) 4. container is composed of any poisonous substance that can contaminate the drug 5. has unsafe color additive 6. if its strength, quality or purity, differs from the compendium standards unless the difference is plainly stated on the label 7. if it is not in a compendium and its strength differs from or its quality falls below that which it represents

NDC indicates 5 things

1. helps automated processing of drug data by government agencies 2. NDC doesn't mean the product has an approved NDA 3. NDC is not required to be on the manufa's label 4. FDA maintains a list of NDC numbers for prescription drugs 5. FDA has proposed a new rule which will provide for a universal standard format for NDC numbers assigned by the FDA, and drug repackagers to have their own NDC numbers

9 things of a misbranded drug

1. if the labeling is false or misleading in any particular way and if it is a prescrption drug 2. the manufaturer's labeling fails to contain all the correct information 3. when a pharmacist fills an Rx w/o authorization of the practitioner 4. if it is an OTC drug and fails to contain all required info 5. if drug liable to deterioration unless it is packaged and labeled accordingly 6. if container is made, formed, or filled as to be misleading 7. if drug is an exact imitation of another drug or for sale under the name of another drug 8. if dangerous to use in the dose or manner suggested in the labeling 9. if its packaging or labeling is in violation of the Poison Prevention Packaging Act (PPPA)

what are the 4 basic forms of regulatory action the FDA can impose in a drug recall: (since the FDA can't order a recall)

1. injunction or restraining order from a court - A civil procedure 2. seizure or embargo - A civil procedure 3. regulatory letter - administrative action by FDA 4. in addition to regulatory action, FDA can pursue criminal action in federal court for certain violation of the act

How must the OTC Drug label come across. 4 things it has to have

1. label and labeling are directed at the consumer. has to be safe for self admin so label MUST contain adequate directions for use, dosage, and precautionary statements. must also have adequate info for use 2. OTC labels must have certain things included 3. OTC drugs marketed w/o an approved application must include a domestic address or domestic phone number through which the manufacturer, packer or distributor IDed on the label can receive reports of serious adverse events associated with use of the product (i.e. herbals) 4. content labeling (drugs containing levels of ca, mg, na, or k that might be harmful to persons with certain underlying medical conditions must state exact dose)

Who and how often do you register with Texas DPS for controls

1. manuf, distributors, prescribers, analyzers, and dispensrs of controlled must register annually 2. DPS also requires a registration to store controlled substances in an emergency kit at a long term care facility, but DEA does not

grounds for denial, revocation, or suspension of the DEA registration

1. materially falsified on any application filed under the FCSA 2. convicted of a felony under the FCSA or any other federal or state law relating to controls 3. had state controlled substance registration suspended, revoked or denied 4. committed such act which would render the regsitration inconsistent with the public interest 5.DEA can deny an application if the Attorney General determines that eh issuance of such would be inconisistent witht he public interest

rules to packaging and repackaging of OTC drugs (2)

1. must be in tamper-evident packaging 2. the repackaging and resale of any OTC drug product, is subject tot he same CGMP and labeling requirements of a manufacturer

how do you treat CIII-CV orders

1. must have readily retriveable record of the receipt of any control. (usually the invoice) 2. invoices must contain: name, dosage form and strength, number of units in each container, quantity received, date of actual receipt, name address and dea registration number of from which controlled substances were received

labeling requirements for controlled substances

1. name & address of the pharmacy 2. phone number of the pharmacy 3. prescription number and date 4. name, initials, or ID code of dispensing pharmacist 5. name of practitioner 6. name of advanced practice nurse or physician assistant if Rx is "carried out" or "signed" by APN or PA 7. name of pt, quantity dispensed, directions, 8. appropriate ancillary instructions, ie storage 9. if CII-CIV, the statement "CAUTION: FEDERAL LAW PROHIBITS THE TRANSFER OF THIS DRUG TO ANY PERSON OTHER THAN THE PATIENT FOR WHOM IT WAS PRESCRIBED" 10. if generic given the statement "SUBSTITUTED FOR BRAND PRESCRIBED OR SUBSTITUTED FOR "BRAND NAME" 11. name & strength of actual drug 12. beyond use date 13. "Do not flush unused medications or pour down a sink or drain"

what things should be included on a 222 forms when filling it out

1. name and address of supplier 2. not valid more than 60 days after execution by purchaser 3. each item shall have name, dosag eform, strength, number of units in each container, and the quantity 4. the purchaser shall record on copy 3 the number of bulk containers furnished on each item and the dated on which the containers are recieved ad initialled on each line 5. number of lines entered 6 person signing must ahve power of attorney 7. address on order form is the ONLY address to which drugs may be delivered (if move, need new order forms)

How do you get yoru DEA 222 forms

1. new registrant - check Item #3 on from 224 for registration of new pharmacy. 2. previous registrant - Re-order by filling out form 222 whichi is on the back of the order forms 3. signature - signed by same person who signed most recent DEA registration/renewal or by person granted power of attorney

how many scripts can be written on a CII form and what if the script has a non control

1. only one CII prescription per form 2. if a prescription has written for a CII and another lower schedule, we must cross out the non CII and transfer it to a pharmacy prescription pad 3. if a non-schedule II is written on an official prescription form alon, fill the script and indicate on the prescription that the drug prescribed is either a "dangerous drug" or mark the schedule it is in.

when transferring the controls to the buyer what has to be done with the controls

1. ont he date of transfer of the controls, a complete inventory of all contraols shall be taken. this will be the final and initial inventory of both parties (each should have a copy) 2. on date of transfer, all records required to be kept by the registrant-transferror with reference to the controlled substances being transferred is talked about alter. accuracy of records prior to the date of transfer remains with the transferor, but responsibility for custody an dmaintenance shall be upon the transferee

what drugs do you have to provide a Patient Package Insert for (3) in any environment

1. oral contraceptives 2. estrogen containing products 3. progesterone containing products

what are the exemptions to child-resistant containers requirement (4)

1. patient/physician request (you can get a blanket request for all RX's from the patient but NOT from the DR). a written request is not required by law, but should be documented 2. bulk containers shipped 3. drugs distributed to institutionalized pts (but hospital employees have to administer to pts) 4. one package size designed for elderly of an OTC product as long as the label says "This package is for households without young children"

what are the 4 sources that they are trying to reduce drug diversion

1. patient: "shopping" different prescribers 2. Physician: non-therapeutic prescribing patterns 3. Pharmacy: non-therapeutic dispensing patterns 4. forged prescriptions

who has power of attorney when ordering CII's

1. person who signed the most recent registration application may execute a Power of Attorney authorizing othe rindividuals to obtain and execute 222 forms to purchase CII drugs 2.the POA must be signed by the person who signed the most recent registration appliciation or renewal and the person being authorized to obtain and execute DEA order forms 3. the POA must be maintained in the pahrancy, be filed with the executed order forms, an be available for inspection 4. A POA may be revoked at anytime by executing a Notice of Revocation

controlled substances rules under the FDCA, what groups are included as a control

1. prescription (legend) drugs which have a high abuse potential with psychological or physical dependency liability 2. additional controls which are regulated under the Federal controlled Substances Act and administered by the DEA and individual states

what are the circumstances that the FDA requires that a Med Guide be dispensed because it determines that they pose a serious public health concern (3)

1. pt labeling could help prevent serious adverse effects 2. the product has serious risks relevant to its benefits of which the patient should be aware of becasue such info could affect patients' decisions to use, or continue to use the product 3. pt adherence to directions is crucial to the drug's effectiveness

what records need to be kept and for how long

1. purchase invoices or records of drug receipt 2. prescriptions are records of drug disposition 3. inventories furnish a record of drugs on hand 4. sale of drugs to practitioners or other pharmacies should be evidenced by written memorandum (store invoice) 5. records are required to be kept for 2 years per FDA, TSBP, DPS, adn DEA. however, Medicare part D requires prescription records be kept in their original form for 3 years and then they can be stored electronically as long as they are retrievable for 10 years

what are the restriction and requirements of emergency dispensing of CII's

1. quantity of drug limited to amount adequate to treat the patient during the emergency period (can treat as long as it is emergent) 2. verbal emergency prescription immediately reduced to writing by the pharmacist containing: full name, address, and age of the patient; full name, address, and DEA number fo the practitioner, date the verbal script was communicated to the pharmacist and drug name, strength, quantity, and directions for use 3. pharmacist shoudl make a good faith effort to verify Dr, so call to make sure 4. practitioner should deliver in person or by mail a written prescirption for the emergency quantity within 7 days. if mailed must be postmarked w/i 7 day period. the prescription must either have written on its face "Authorization for Emergency Dispensing," OR in Texas, the dr must check the block at the bottome of the script 5. the pharmacist will notify the nearest DEA office if the Dr doesn't do this (if not received both parties violated the act 6. pharmacist attache oral emergency presciption to the written presciption and files both in CII file

log book requirements for regulated items behind the counter

1. retailer must maintain an electronic or written log book that ID's the products by name, quantity sold, names and addresses of purchases, dates and times of sales, but there is an exception for hte log book for individual sales of a single "convenience" package of less than 60 mg of pseudoephedrine 2. non-pharmacy retailers msut be certified by the dept. of health services to sell

when is a perpetual inventory required in TExas

1. schedule II drugs only in class C (institutional) pharmacies 2. all controlled drugs stored at a remote location under the Remote Pharmacy Rules

What are the 3 limited situations in which the DEA and Texas allow faxed scripts to serve as the original

1. scripts faxed for a CII narcotic to be compounded for the direct administration to a patient by parenteral, IV, IM, SC, or intraspinal infusion (only for CII) 2. Prescriptions faxed by a practitioner or practitioner's agent for a CII for a resident of a long-term care facility 3. scripts faxed for a CII for a patient enrolled in a hospice care program certified and/or paid for by Medicaid or licensed by the state (must be noted that the pt is a hospice patient)

what are some elements to assure safe use (6)

1. special training, certification in prescribing 2. special certification for pharmacies, practice etc that dispense 3. the drugs is dispensed to pts only in certain health care settings such as hospitals 4. the drug is dispensed to pts with evidence or other documentation of safe use conditions, such as lab test results 5. each pt using the drug is subject to certain monitoring or 6. each patient using hte drug is enrolled in a registry

rules for OTC sale of CV's

1. the actual cash transfer and delivery of the drug may be done by non-pharmacist employee but a pharmacist must co-sign (this is for federal law really)

violations of the FDCA (6) in regards to adulteration and misbranding

1. the adulteration or misbranding of any drug in interstate commerce 2. the intro into interstate commerce of any drug that is adulterated or misbranded 3. receipt in interstate commerce of any drug that is adult. or misbr. and the delivery of it 4. the alteration, mutilation, removal, etc. of the labeling of a drug while it is held for sale which results in the drug being adult. or misbranded 5. failure to keep adequate records 6. refusal to permit entry to FDA inspectors to inspect and verify records

In Texas (TCSA), who may add, delete, or reschedule substances

1. the commissioner of the Texas Department of Health with the approval of the TExas Board of Health 2.The Commissioner can't add any substance to the schedules if the substance has been deleted from the schedules by the legislature 3. The Commisioner can't add any substance tot he schedules if the substance was sought to be added to the schedules by the legislature, but failed to pass 4. if a controlled substance is added, deleted or rescheduled under the FCSA, it will be included or removed from that schedule in Texas unless the Commissioner objects to the inclusion or deletion

Office-based Tmt of Opiate Dependence means the prescriber has what and what drugs are approved under the act

1. the dr has an X number on their a DEA, with this DEA number they can't order vicodin. so they ahve 2 DEA's 2. Subutex (buprenorphine) and Suboxone (buprenorphine/naloxone combination) (both are CIII's availabel in SL form and may be dispensed by a pharmacy)

who are the only four individuals emplyed by the narcotic tmt program that can dispense or administer narcotics to the pt

1. the licensed physician 2. a registered nurse under the direction of the licensed dr. 3. a licensed practical nurse under direction of the dr 4. a pharmacist under the direction fo the licensed dr.

what must be submitted to the DEA Registration Field office when changing owners

1. the name, address, reg #, and authorized business activity of the pharmacy discontinuing the business (registrant-transferor) 2. " " of the person acquiring the pharmacy (registrant-transferee) 3. whether the business activities well be continued at the location registered before or moved to another location (if moved, put address of new location) 4. the date on which the transfer of controlled substances will occur

what requirements need to be met to use the old owners DEA until they get their own

1. the new owner must expeditiously apply for an appropriate DEA and state registration 2. the previous owner provides a Power of Attorney to the new owner for the following: the previous owner knows that he or she will be held accountable for any violations, new owner must notify local DEA office of the proposed use of the previous owner's DEA registration MAY if requested, furnish a copy of the Power of ATTorney, the borrowed DEA registration can only be used for no more than 45 days after purchase date

what do you have to do to transfer controlled substances upon sale of a pharmacy

1. the old owner shall submit in person or by registered or certified mail, return receipt requested, to the nearest DEA registration FIeld office the following info in next question 2.unless the registrant-transferor is told by the DEA that they CAN'T distribute, they can distribute (w/o being registered) as long as they follow the rules

what 4 things have to be met to be exempt from FDA advertising regulations

1. the only purpose of the advertising is to provide info on price, not info on the drug's safety, efficacy, or indications for use 2. the advertising contains the proprietary name of the drug, if any; the generic name of the drug; the drug's strength; the dosage form; and the price charged for a specific quantity of the drug. 3. the advertising may include other info, such as the availability of professional or others types of services, as long as it is not misleading 4. the price stated in the ad shall include all charges to the consumer, mailing fees and delivery fees, if any, may be stated separately

define dispenser of controlled substances and list the types of dispensers (3)

1. the pharmacy (not the pharmacist) 2. institutional practitioner - a hospital or other facility authorized to dispense a controlled substance, but not include a pharmacy 3. individual practitioner - a physician, dentist, vet, podiatrist, or other

under what conditions can a PA/APN "carry out" or "sign" prescription drug orders for controlls

1. the prescription is for a CIII-CV 2.CII prescriptions are not allowed 3. the prescription, including a refill may not exceed a 90 day supply (they can't do more than 1 refill and if they do need extra, they need to call in a new script) 4. for scripts for a child less than 2, the PA/APN must consult with the delgating physician and the consultation is noted int eh pateitns' chart

how is a controlled substance prescription issued

1. the prescription may be prepared by teh paractitioner or thier agent, but must be manually signed by the practitioner like a legal document (no stamps allowed) 2. all prescriptions shall be dated and signed on the day the prescrition is issued changing info or information omitted depends on the control class

in what 4 ways can a prescription drug be dispensed

1. upon a written prescription issued by a licensed practitioner 2. upon an oral prescription by practitioner which is promptly reduced to writing and filed by pharmacist 3. by refilling a written or oral prescription if authorized by the practitioner 4. by administration or dispensing directly by the practitioner

what 6 things does a prescription label have to have to be exempted from most of the manufacturer's labeling requirements

1.Name and address of dispenser (pharmacy) 2. serial number (RX number) or prescription 3. date of the prescription or filling 4. name of prescriber 5. name of patient 6. directions for use and cautionary statements, if any, contained in the prescription

Rules of oral prescriptions

1.a practitioner may not designate as an agent another practitioner who is not a registrant 2. a designated agent must be a registered nurse, vocational nurse, physician assistant all licensed in Texas, or an employee located int he designating practitioner's office who is a member of the staff 3. a designating practitioner shall maintain in the practitioner's usual place of business a current written list of persons designated as agents, and a practitioner shall provide the current list to all pharmacists who request a list

how can you get the 222 form to where it needs to go

1.can give order form to contract drivers of a distribution center as long as it is in a sealed envelope. 2. can FAX to distribution center to expedite the filling process and/or FAX on behalf of a customer by an employee driver or other employee to a distribution center to facilitate the filling process. but the order can't be released until the original DEA form is received at the distribution center adn compared by an employee of the DEA registrant filling the CII to the fAX

tamper-evident packaging rules (3)

1.manufac and packagers of OTC drugs (except dermatological, dentifrice (anything to maintain oral hygiene), insulin, or lozenge products) for retail sale must package products in a tamper-evident package 2. any two-piece, hard gelatin capsule must be sealed using an acceptable tamper-evident technology 3. each retail package of an OTC drug product is required to bear a statement that ID's all temper-evident features and any capsule sealing technologies and is prominently placed on package

what are the 7 examples in the Prescription Drug Marketing Act of 1987

1.requires state licensing of prescription drug wholesale distributors under federal guidelines 2. requires wholesale distributors who are not the manufacturer or an authorized distributor of record of a prescription drug to provide to the person who receives the drug a statement IDing each prior sale, purchase, or trade of the drug, commonly called a drug pedigree 3. bans reimportation of the RX drugs produced in US 4. bans sale, trade, or purchase of samples, 5.mandates storage, handling, and record-keeping requirements for drug samples 6. prohibits, with certain exceptions, the resale of RX drugs purchased by hospitals or health care facilities 7. establishes criminal and civil penalties for violations of the Act

What does the National Drug Code numbers stand for

10-11 character number divided into 3 segments: first 4-5 are assigned by the FDA is the labeler code. the next 4 digits are assigned by the manufacturer are the drug product code. the last 2 digits are the packaging code

what are the special warning requirements for OTC products in FDCA (10-12)

10. pheacetin (acetophenetidin) - must contain warning about possible kidney damage when taken in large amounts or for long period of time. 11. salicylates - aspirin and othe rsalicylate drug smust have special warning sof ruse in children including warning with Reye's. retail containers of 1 1/4 grain (peds) asa tabs cant be distributed in retail containers containing more than 36 tabls 12 alcohol warning - internal analgesics and antipyretics in cluding APAP, ASA, ibuprofen, naproxen, ketoprofen, etc. are required to have warning for persons consuming three or more alcoholic bev per day to talk to doc before taking

Drugs covered under the Federal Poison Prevention Packaging Act exemptions for prescriptions drugs (12-17)

12. pancrelipase tab, cap, or powder form 13. medically admin oral contraceptives in man mneumonic dispenser 14. prednisone in tabs with max 105mg 15. conj. estrogen tabs from a mnemonic dispenser pack with max 26.5 mg 16. norethindrone acetate tabs in mnemonic dispenser with max 50mg 17. medroxyprogesterone acetate tabs

What is the Pure Food and Drug Act and what year was it started

1906 prohibited interstate commerce of misbranded and adulterated foods, drinks, and drugs (purity standards only; no efficacy requirements)

what is the Federal Food, Drug, and Cosmetic Act (FDCA) and what year

1938 1. extended coverage to cosmetics and devices 2. required pre-distribution clearance for safety of new drugs 3. eliminated requirement to prove intent to defraud in drug misbranding cases 4. provided for tolerace for unavoidable poisonous substanced in foods 5. created the FDA as we know it today 6. authorized factory inspections by FDA 7. added injunction procedures by FDA

what is the Durham-Humphrey Amendments and what year

1951 1. basic provision required that drugs that can't be used safely without medical supervision must be dispensed by qualified practitioner and as a prescription 2. so which drugs must be administered or dispensed on prescription only bases

what is the Prescription Drug Marketing Act and what year

1987 - amended the FDCA to reduce the potential public health risks that may result from diversion of prescription drugs from legitimate commercial channels. requires wholesale distributors who aren't manufacturers' distributors to follow a set of rules. The reimportation of human drugs produced in the US is banned except when reimported by the manufacturer or after FDA approval for emergency use, bans the sale, trade or purchase of drug samples and trafficking in and counterfeiting of drug coupons, PDMA requires all requests for drug samples be made in writing by licensed practitioners and properly stored and handled and record keeping

what does iPLEDGE require rules 4-8

4. to dispense the pharmacy must obtain authorization from iPLEDGE signifying the pt is registered, has received counseling and education, and is not pregnant 5. must be picked up w/i 7 days of PREGNANCY TEST (not always date of prescription). if not picked up within the 7 days can get another test or the claim MUST be reversed via phone 6. a max of 30 days supply may be dispensed 7. blister packages may not be broken 8. no refills are allowed

what are the special warning requirements for OTC products in FDCA (4-6)

4.Mineral Oil - requires warning to only be taken at bedtime and not be used in infants unless under advice of a physician. can't encourage during pregnancy 5. Wintergreen oil (methyl salicylate) - any drug with more than 5% methyl salicylate (flavoring) must include warning that use other than directed may be dangerous and that the article should be kept out of reach of children 6. isoproterenol inhalation preparations - requires warnign not to exceed dose prescribed and to contact physician if difficulty breathing persists

what is the max concentration for CV opium products in texas

50 mg/100ml

Drugs covered under the Federal Poison Prevention Packaging Act exemptions for prescriptions drugs (6-11)

6. potassium supplements in any unit dose form with not more than 50 mEq per unit dose 7. sodium fluoride in liquid and tab with no more than 264 mg 8. betamethasone tabs in manufa dispenser packages with max 12.6 mg of betamethasone 9. mebendazole in tab from in packages with max 600mg 10. methylprednisolone in tab form with max 84mg 11. colestipol in powder with max 5g

what things does the FDA considering in determining whether to initiate action on a compounding pharmacy (6-9)

6. using commercial scale manufactur or testing equipmet for compounding drug products (more of a manufac than pharm 7. compounding drugs for 3rd parites who resell to individual patients or offering coumpounded drug products at wholesale to other state licensed persons or commercial entities for resale 8.compounding drug products that are commercially in the marketplace or that are essentially copies of them (unless there is a medical need for a particular variation of the compound for a particular patient 9.failing to operate in conformance with applicable state law regulating the practice of pharmacy

how many days does a supplier have to send the balance of a partial balance

60 days

what are the special warning requirements for OTC products in FDCA (7-9)

7. potassium salt preparations for oral ingestions - requires warning regarding nonspecific small-bowel lesions consisting of stenoisis, with or w/o ulcerations associated with the admin of enteric-coated thiazides with potassium salts. warning is that it should be DCed immediately if abdominal pain, distention, nausea, vomiting, or GI bleeding occur 8. sodium phophates - limits the amount of oral son to not more than 90 mL per OTC container 9. Ipecac syrup

what do the letters in front of a DEA number mean

A if the registrant is a pharmacy or practitioner registered before 6/1/1985, they can also have B or F. the second letter will be the first letter of their last name or pharmacy name. midlevel practitioners DEA begins with the letter "M"

what is the official name of the FDA orange book

Approved Drug Products with Therapeutic Equivalence Evaluations

what documents can and cannot be inspected by the DEA

DEA can inspect and copy any record, report or can inspect contorls, inventory of controls and obtain samples. however, they are not allowed to inspect financial, sales, and pricing data without the consent of the registrant

after completing the DEA form 106 who do you ahve to provide a copy to

DEA, DPS, TSBP and MAY report to local poice

upon discovery fo the theft/loss immediately report it to

DEA, DPS, local police, and TSBP

name the 3 DEA forms for registration

DEA-224 - for dispensers, including retail pharamcies, hospitals, clinicts, practitioners and teaching. a renewal foram is the DEA-224a DEA-225 - for manufacturers, distributors, researchers, analytical labs, importers, exporters. renewal is DEA-225a DEA-363 - for narcotic treatment facilities

define scope of practice:

Dentists, podiatrists, and veterinarians may only prescribe drugs used within their scope of practice. optometrists limited to specific drug classes

who and where do you register if you are dealing with controlled substances

Every person or firm who manufactures, distributes, or dispenses any controlled substance must register with DEA and in Texas with the Department of Public Safety (DPS)

Who regulates if a drug is adulterated or misbranded

FDA

who regulates the products

FDA

who regulates prescription drug advertising

FDA (advertising also includes what is on the label)

What is the FDA allowed to recall

FDA can't order a drug recall technically (has to be done by manuf or distrib), but FDA does have the authority to order a recall of devices. FDA MAY issue an order requiring the appropriate person (including the manufact, distibutors, or retailers) of the device to 1. cease distribution of the device. 2. immediately notify health professionals and facilities to cease use of such device

Current Good Manufacturing practices apply when in a pharmacy?

FDA's CGMP regulations apply to a pharmacy only if it is engaged in manufacturing repackaging, and/or relabeling drugs beyond the usual conduct of dispensing and selling at retail.

T/F DEA and texas requires a pharmacy maintain a perpetual inventory of all controls

False

T/F breakage or spillage of a controlled substance is considered a "loss"

False

T/F faxes of CII's are permitted

False

T/F you can store of all controlled substances on one unsercured shelf

False

how does TSBP allow filing to be done

File #1 - schedule II FIle #2 - schedule III, IV, and V File #3 - dangerous drugs and OTC drugs

in addition to all controlled substances, TSBP also requires the inventory include all dosage forms of which two drugs

Nubain (nalbuphine) and (Soma) carisoprodol

what are the special warning requirements for OTC products in FDCA (13)

OTC pain relievers: 1. APAP - a. the APAP must be prominently IDed on the product's principal display panel of the immediate container, and the outer carton (to keep from getting multiply APAP products) 2. the product label must contain warning that highlight the potential for liver toxicity and warn consumers against using more than the recommended dose and only mod amnts of alcohol 3. the label must have warning not to use APAP with any other drug with APAP and ask before use if on blood thinners NSAIDs : 1. "NSAID" must be prominent on display panel 2. the product label must contain a "stomach bleeding warning" and highlights the potential for it in persons over age 60, prioir ulcers or bleeding, and on blod thinners, and when taking more than one NSAID product, mod alcohol, and longer than directed 3. label must have warning to ask dr before or if stomach bleeding ocurs

what is the difference between a prescription and OTC direction for use

Package insert has adequate information for use whereas OTC label has adequate directions for safe use

what is REMS.

Risk Evaluation and Mitigation Strategy. it is a strategy to manage a known or potential serious risk associated with a drug or biological product.

who enforces the rules of the TCSA

Texas Department of Public Safety (DPS)

When is a pharmacist required to provide a PPI to a patient in a hospital or institution

The PPI may be provided as detailed above or it MAY be provided before the administration of the first dose and once every 30 days thereafter.

federally (FCSA), who may add, delete, or reschedule substances

The U.S. Attorney General may, but must consult with the Secretary of US Department of Health and Human Services

What authority is the DEA under

The US Department of Justice. the DEA implements the Federal Controlled Substances Act through regulations

T/F CII in a class C (hospital) pharmacy in Texas must be stored in a locked cabinet

True

T/F DEA does not decide who can prescribe only the state can

True

T/F a registrant must provide, in writing, initial notification of the event of theft within one business day of discovery by fax or other means , but must be in writing, to DPS and TSBP as well as DEA

True

T/F advance paractice nurses and physicians assistants in texas may only prescribe a total 90 day supply (including refills) of a CIII-CV

True

T/F drug reps can verbally misbrand

True

T/F if federal and texas law cannot be consisitent, then the state law must yield to the federal

True

T/F the more stringent law or regulation is to be followed whether Texas or federal

True

T/F you can store controlled substances throughout the noncontrolled drug stock

True

T/Fif an investingation on a theft or loss lasts longer than 2 months, registrants should provide updates to the DEA

True

T/F prescriptions from Canada and Mexico can be legally filledonly if the pharmacist has the original written prescription (hand written)

True but can only be dangerous drugs, not controls

T/F it is unlawful to possess dangerous drugs unless you are a registered pharmacist, practitioner, or registered nruse, PA all in the course of practice to deliver the drug

True, but the drug has to have been prescribed legally and have a label attached to the container with the name and address of the pharmacy, date dispensed, and prescription number etc. also the name of the patient, and if for an animal, the species of the animal

If a products does not have the Package insert, is it misbranded

Yes

what kind of things can a REMS program require

a medication guide, patient package insert, a communication plan, elements to assure safe use, and an implementation system, and must include a timetable for assessment of the REMS

what is the time limit for filling CII's

a regular CII script has to be filled within 21 days after the date issued or 21 days after the fill until later date. LTCF CII scripts have 60days

name some drugs requiring med guides

accutane, antidepressants in children and teenagers, coumadin, forteo (teriparatide), lindane shampoo and lotion, lotronex (alosetron HCl), nolvadex (tamoxifen), NSAIDs, Remicade (infliximab), Trizivar (Abacavir, Lamivudine, and Zidovudine)

who enforces the poison prevention packaging act of 1970 (PPPA)

administered and enforced by the Consumer Product Safety Commision (CPSC)

who enforces the Food and Drug and Cosmetic Act

administered and enforced by the US food and drug administration

what are the types of labeling

all labels and other written, printed or graphic matter (even in package insert) upon the article or container. also includes any advertising and representations made by a detail person (rep)

what do you do with the annual inventory afterwards

annual inventory is signed by the pharmacist-in-charge and notarized within 72 hours or 3 working days

CV drugs

antitussives with codeine, antidiarrhealss with opium: robitussin AC, Lomotil, Lyrica,

define cosmetic

articles intended to be rubbed, poured, etc. into or on the body for the purpose of cleansing, beautifying, or altering the appearance of the body

what does a pharmacy that repackages drugs for sale or distribution to other pharmacies or facilities not under common ownership must also do

be registered by the Texas Department of Health (Drug and Medical Device Division) as a distributor

define designated agent

employee of the practitioner who is allowed to communicate but not authorize prescriptions to the pharmacist over the phone

what is the offecnse for forging or altering prescriptions

class Bmisdemeanor or class A misdemeanor if the defendant has been previously convicted for a dangerous drug offense

TSBP rules require pharmacies to take an inventory of all controlled substances every how many years

every year and it requires exact counts on CII's and estimate on CIII-CV's unless the container has more than 1000 tabs or caps then need an exact count if it has been opened

what is a class III drug and device recall

exists where the use of, or exposure to, a violative product is not likely to cause adverse health consequences (wont issue a press release, company MUST notify distributors/vendors)

PRN refill limit is how many

defines ad one year from date of issuance

what is the Orange book

determine generic equivalency of drugs using AA if equivalent and AB if not equivalent

define label

display of written, printed, or graphic matter on the immediate container

define narcotic

drugs that are derivatives of opium, poppy straw, cocaine, or ecgonine

What can therapeutic optometrists prescribe

drugs to treat he eye and adnexa (tissue surrounding the eye) but may not prescribe drugs to treat glaucoma or controls. can prescribe and administer: OTC oral meds, ophthalmic devices (contacts), and certain TOPICAL ocular pharmaceutical agents. (these optometrists have a T in their license)

how do the DEA order form 222 books come

each book has 7 sets of triplicate forms and a max of 6 books in one order

what is a class II drug and device recall

exists where the use of, or exposure to, a violative product may cause temporary or medically reversible adverse effects on health is remote (manufacturer MUST notify distributors and vendors and MAY ask them to notify patients, may but does not always expect to issue a press release

what is a class I drug and device recall

exists where there is a reasonable possiblity that the use of, or exposure to, a violative product will cause serious adverse effects on health or death (MUST take off shelf and MUST notify manufacturers and patients, company and FDA may issue a press release)

T/F you can prescribe drugs "for Office Use"

false, they need to order from a wholesaler, or manufacturer, or a pharmacy if they use the appropriate forms for controlled substances (prescriptions are always for a patient, not for an office)

an OTC drug may be approved for marketing by:

filing a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) or by marketing in compliance with the requirements of an OTC monograph which sets for the active ingredients, labeling, and other general requirements.

which REMS program is for Isotretinoin (Accutane)

iPLEDGE to prevent use during pregnancy

how are controls scheduled when compounded

if a prescription has narcotics in an amount greater than the max allowed in CV then it becomes CIII, CIII to CII,

define medical device

instrument, apparatus, intended for use in dx, cure, mitigation, tmt or prevention of dx in man or animal or intended to affect the structure or any function of the body of man or animal which does not achieve its intended purpose through chemical or biological action within or on the body

what do you do with lost or stolen used or unused forms

notify the registration unit of DEa in Washington immediately

Central Record keeping is allowed if

invoices and financial data for controls may be maintained a t acentral location if 1. prior to the start, the pahramcy submits written notification by registered or certified mail to the divisional director fo the DEA and TSBP. they can start to keep records centrally after 14 days if they are not told not to do so. 2. keep a copy of the notification to DEA. 3. records to be maintained at the central location shall not include executed (used) DEA order forms (222), prescription, or controlled substance inventories, which shall be maintained at the pahramcy. (DEA still require original hardcopies of controls to be readily available upon request)

what is the limit on refills for CIII and CV drugs

it is 5 full refills within 6 months from the date of initial issuance. if less than 5 refills were authorized on original, additional refills may be given if the total of all refilss does not exceed 5 and extend beyong 6 month period

what are the display restrictions for regulated items

must be placed behind a counter (any counter) or if located on the selling floor, in a locked cabinet w/i 30 feet of and in a direct line of sight from a pharmacy counter

what does the DEA 106 form have to include

name, address of the registran (pharmacy), DEA registration number, date of theft, name and telephone number of local police dep nontified, type of theft, listing of symbols or cost code used by pharmacy in marking containers (if any), listing of controls missing from theft or significant loss, the NDC number of the missing products

are PPIs required to be provided to pts undergoing emergency treatment; failure to provide a PPI is considered to be misbranded or adulterated

no misbranded

T/F if an out of state dr prescribes a CII drug, can you fill it?

no, bc they are not registered with DPS, but there are exceptions for mail order (they has to submit a plan to the PDS which ahs been approved byt he DPS adn the TSBP)

Do postal regulations administered by the U.S. postal service allow dangerous substances to be mailed

no, but there are exceptions

When is a pharmacist required to provide a PPI to a patient in a retail pharmacy

one to each pt to whom the drug is dispensed for new and refill prescriptions. they are also available in spanish upon request. sample forms of PPIs are provided by the FDA

"signing" defined

only the PA/APN is required to sign the prescription, both names will always go on the prescription label

what does iPLEDGE require rules 1-3 of 8

only wholesalers registered can have it from manufa.'s, only pharmacies registered in iPLEDGE can receive it from registered wholesalers and unregistered wholesalers and pharmacies must return unused isotretinoin 1.only docs registered can prescribe (they MUST register neg test results for female patients prior to prescribing) 2. only pts registered can be prescribed.(must complete consent form, obtain counseling about the risks and requirements for safe use and for women of childbearing potential, complying with required pregnancy testing and use of contraception) 3. only pharmacies registered can dispense (pharmacy must select a pharmacist to get the program info and registration materials and sign and return the complete registration form

list the C I drugs

opiates, derivative such as heroin and dihydromorphine, marijuana, LSD, MDMA (ecstasy), peyote, mescaline, depressants such as methaqualone

CII drugs

opium, morphine, codeine, hydrocodone, methadone, meperidine, hydromorphone, fentanyl, cocaine, amphetamines, phenmetrazine, pentobarbital (oral) secobarbital (oral), amobarbital (oral), glutethimide, and phencyclidine

define "Corresponding Responsibility"

our role in being responsible for validity of prescriptions and we have the responsiblity to reject, fraudulent, improper prescribing and dispensin gof controls

What are the requirements of the PPPA with kids and adults

packaging must be tested by kids and if more than 20% of the kids can open after demostration and/or if more than 10% of the adults tested can't open it then it fails. 10 min for kids and 5 min for adults (can't reuse a prescription container bc the child safety decreases in effectiveness)

who can prescirbe controsl

physicians, dentists, podiatrists, and vets can prescribe and have DEA registrations, Mid-level practitioners can prescribe CIII-CV only

CIV drugs

propoxyphene, dextropropoxyphene, butorphanol, pentazocine, and products with not more than 1 mg of difenoxin and not less than 25 micrograms of atropine sulfate per unit; xanax, valium, ativan, chloral hydrate, phenobarbital, diethylpropion and phentermine (SOMA)

how do you transfer schedule III, IV, V

provide original commercial invoice from transferring (selling) pharmacy to purchasing registrant containing: date of transfer, number of units, # commercial containers, name, strenth, and dosage form, name and address and DEA registration number of the transferring pharmacy. name, address and DEA registration number of hte pharmacy or practitioner to whom the controlled substances are transferred. a copy is retained by supplier or ditributor (the pharmacy) and original retained by recipient) (this is the opposite of CII's)

CIII drugs

schedule II drugs but in combo with another ingredient like ASA with codeine, or APAP w/ hydrocodone, suppository amobarbital, secobarbital, or pentobarbital; stimulants like chlorphentermine, phendimetrazine, benzphetamine, anabolic steroids, ketamine and paregoric

what do you do with all unused DEA 222 forms if registrant discontinues business

send all unused forms and DEA registration certificate tot he appropriate DEA divisional office by registered mial

what is the consequence of manufacturing dangerous drugs without authorization

state jail felony

what are the requirements of the PPPA with unit dose packaging

test failure is when the ability of one child can open more than 8 units or the number of units representing a toxic amount, whichever is less

who regulates OTC advertising

the Federal Trade Commission (FTC)

how do you distribute controls to hopital owned ambulances

the ambulance is considered as a department of the hospital. controls may be distributed to the ambulance on "proof--of-use" form or other internal distribution record int he same manenr as controlled drugs (so no 222)

DEA form 223 contains what

the certificate of registration from the DEA 1. name, address, registration number of the registrant; activity authorized; schedules of controlled substanced authorized to handle; fee paid; and expiration date 2. the certificate shall be maintained at the pahrmacy in a readily retrievable manner and be available for inspection authorized by federal or state agents but does not have to displayed

If a patient wants the original quantity increased on a control what does the pharmacist have to do

the pharmacist must obtain the prescriber's permission to generate a new prescription

what is the "Distributor" rule

the pharmacy does not have to register with DEA as a distributor as long as total quantities of controls distirbuted to another registrant (pharmacy) during a 12 motnh period in which the pharmacy is registered do not exceed 5% of the total quantity of all contros dispensed and distributed ruign that same 12 months

what do you do with the copies of a triplicate for

the practitioner may provide the patient with copy 1 or copy 1 and 2. if the pharmacist receives copies 1 and 2, the pharmacist should attach copy 2 to copy 1 since copy 2 is no longer required to be sent to DPS (copy 1 is a valid prescription)

where can you find the DEA 106 form

there is a paper version but the DEA recommends using the online one at the Office of Diversion Control's website www.deadiversion.usdoj.gov

optometric glaucoma specialists can prescribe what

these have a license ending in TG They can prescribe all a therapeutic opt drugs plus a 10 day supply or oral antibiotics, a 3 days supply of oral antihistamines, one 7 days supply of NSAIDs, one 3 days supply of any analgesic in controlles III-V

define Biological products and list some examples

these include vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins

DEA and Texas DPS allow what for a 90 day CII script

they can issue multiple crits on the same day so the pt can receive a total of up to 90 days supply if: 1. earlies fill date is written on the script

self-prescribing rules

they can prescribe to family and friends, but: 1. have to take a history, physical exam and maintain adequate records 2. innappropriate prescribing includes prescribing controls in teh absence of immediate need which is considered no more than 72 hours

where do you dispose of damaged controls and how do you document

through shipment to a "reverse distributor." if the breakage or spillage is not recoverable, the registrant must document the circumstances of the breakage in their inventory records. 2 individuals who sitnessed the breakage must sign the inventory records. the submission of a DEA form 41, Registrants Inventory of Drugs Surrendered is not required for non-recoverable controlled substances

what is the purpose of the Poison prevention packaging act

to exted to prescription and non-prescription drugs special packaging requirements known as "child resistant container"

what do you do if you want to transfer schedule II drugs

trasferee (purchasing pharmacy or doctor) must execute a DEA order form (222) to the transferring (selling) pharmacy (supplier or distributor)

T/F a misfill is adulterated and misbranded

true

T/F all narcotics are controlled substances, not all controlled substances are narcotics

true

Is carisoprodol a CIV drug

under Texas law it is, but FDA says no so

administering a dangerous drug in home and community support services agencies rules

usually ordered verbally by a physician and they have to promptly send a signed copy fo the order tot he agency, and the agency shall: 1. no later than 24 hours after receipt of the order, reduce the order to written form and send a copy to the dispensing pharmacy; and 2. not later than 20 days after receipt of the order, send a copy fo the order as signed by and received from the physician to the dispensing pharmacy