Federal Flashcards
National prescription drug take back day
-DEA program
-day in April and October where sites set up all over for people to bring unused meds for disposal
How often must DEA registration be renewed? Cost?
-Every 3 years
-$888
-DEA form 224a
DEA form 224a
Renewal of DEA registration
DEA form 222
Ordering C1 and CII
DEA form 106
Theft or loss of CS
DEA form 41
Destruction of CS
Includes expiration, spillage, breakage- don’t get tripped up!
Pure food and drug act 1906 (Wiley)
-food and drug cannot be misbranded
-“truthful labeling” and attempted to ensure drugs were pure
-did not require ingredients or directions to be listed on label
-did not address cosmetics or medical devices
In violation of the act of drug is adulterated or misbranded
Food, drug, cosmetic act of 1938
-new drugs must be proven safe
-labels must include directions and warnings about habit forming drugs
-applies to cosmetics and devices as well
Drugs before 1938 grandfathered in
Durham-Humphrey amendment of 1951
-rx vs OTC
-Rx “adequate directions for use” satisfied by label placed on bottle
-also allowed for oral prescriptions and refills
Kefauver-Harris Amendment of 1962
-response to thalidomide
-required safety AND efficacy
-FDA to regulate Rx drug advertising
-informed consent for research
-Good manufacturing practice reqs
Note: OTC advertising is regulated by the Federal Trade Commission (FTC)
Medical device amendment of 1976
-Better classification if medical devices
-performance standards for devices
-premarket approval standards
-GMP
Orphan drug act
-tax and licensing incentives for manufacturers for drugs that tx dxs that affect <200,000 people in US
Drug price competition and patent term restoration act
-Hatch waxman act
-Streamlined approval of generics via abbreviated NDA (ANDA) (requires only proof of bioequivalence)
-Brand name gets additional 5 years of patent protection to compensate for more lengthy approval process
FDA modernization act of 1997
Touches virtually every aspect of FDAs activities
-fast track more urgently needed drugs
-compounding stuff
-“caution federal law prohibits dispensing w/o Rx”
-“warning may be habit forming”
-encourages manufacturers to do more research
-6 months market exclusivity for pediatric drugs
Patient protection and affordable care act of 2010 (health care reform act)
-Requires all individuals have health insurance
-timely and transparent claims
-stop brand and generic agreements that limit or delay generic competition
-phase out the donut hole
-can’t deny children ins who have pre-existing conditions
-kids stay on parents until 26
Is soap a cosmetic
No
Device vs drug
-recognized is usp/nf or hpus
-use in diagnosis, cure, mitigation, Tx or prevention of dx
-intended to affect structure or function of body but is not a food
Drug is basically the same but not a device
Medicare parts A-D
A: hospital
B: physician services
C: Managed care (advantage)
D: prescription drugs
Which drug categories must insurers keep most drugs on formulary?
6:
-anticonvulsants
-antidepressants
-antineoplastics
-antipsychotics
-antiretrovirals
-immunosuppressants
Part D formulary changes
-clear with CMS (60 day notice) unless new black box warning then can remove anytime
-if person taking that drug must continue to get it without penalty for the rest of the plan year
Part D out of network pharmacies (on vacation or out of stock)
-beneficiary pay and submit for reimbursement
Enrollment window for Medicare part d
7 month window spans 3 months before and after the month of their bday
Note: A and B are automatic
How long does FDA have to decide on IND?
30 days
Note: IND contains preclinical studies and methodologies (clinical protocols) for testing
Goal of each phase clinical trial
Phase 1; toxicological, PK, pharmacological properties and safety
Phase 2; 100+ pts, efficacy, adequate dosage, relative safety, ADRs
Phase 3; thousands in mx geographical regions, effectiveness
Treatment IND
For pt not enrolled but will likely die without it (no cure etc.)
Must be in phase 2 or 3 trials
FDA expedited review programs
Priority review: for biologics applications or NDA, below three may also get priority. Reduces FDA review from 10 to 6 months
Fast track: drugs for unmet clinical need
Breakthrough: early clinical evidence of substantial benefit over existing drugs
Accelerated approval: for drugs with long endpoints like OS. Can use other endpoints like DFS but need to validate results in post marketing
ANDA
-Abbreviated NDA for generics
-must show bioequivalence
-first one to do this gets 6 months exclusivity
SNDA
Supplemental NDA for after marketing changes to anything (dosage form, tablet strength, therapeutic use, etc.)
Type p vs type s drugs
P: no other effective drugs in this area (get priority)
S: similar to other drugs (standard review
Vaccines for children
Federally funded program providing 16 vaccines at no cost for children would wouldn’t get them due to cost
NDC segment meaning
1234 (manufacturer)- 5678 (drug)-01 (package size
NDC segment meaning
1234 (manufacturer)- 5678 (drug)-01 (package size)
Not required to appear on bottles, labels, etc.
How often does FDA inspect manufacturer facilities
Every 2 years unless prior deficiencies
Office of prescription drug promotion
FDA sector that handles reports on bad or misleading advertising of drugs
“Rx only” or “Rx” symbol
“caution federal law prohibits dispensing w/o Rx” simplified to “Rx only”
Must say for prescription drugs but doesn’t need to say it when dispensing to customer
(Otherwise misbranded)
Interesting examples of misbranding
-dispensing a drug without legal prescription or refills
-quantity not listed
-missing name or location of manufacturer
-OTC package on the shelf whose package is damaged
-not giving Medguide of PPI unless specifically directed to withhold by prescriber (if pt requests it then it must be provided even if prescriber directed otherwise)
Note: product insert is considered part of labeling
Note: products do NOT require adequate directions for use if they are rx only to be dispensed by pharmacists, must have “caution federal law prohibits dispensing w/o Rx” simplified to “Rx only”
Manufacturer container label reqs
-name and address of manufacturer
-drug name
-net quantity
-weight of active ingredient (e.g., 10 mg or 2 mg/mL)
-“federal law prohibits…” or “Rx only”
-route if not oral
-special storage directions if applicable
-lot #
-exp date
If not adhered to it’s misbranding
Special warnings required for which additives
-yellow 5 (tartrazine)
-aspartame
-sulfites
-mineral oil
-wintergreen oil (methyl salicylate)
-sodium phosphate
-isoproterenol inh products
-ipecac syrup
-acetophenetidin
-salicylates
-alcohol warning
Prescription drug marketing act of 1987 (Dingle bill)
-corrects the problem of drug diversion from normal distribution channels
-lots regarding shipping of drugs and stuff
-retail pharmacies may NOT have samples
-restricts resale of drugs by facilities
-restrict importation Of drugs outside US
-restrict distribution of samples
-regulate wholesalers
-required “pedigrees” (keep x3 yrs)
-minimize presence of counterfeit drugs
Drug samples
-Retail pharmacies cannot have!
-healthcare facility pharmacies can have IF prescribed requests them
-prescribers can have if they provide written request
Max volume of Ipecac syrup sold?
1 ounce (30 mL)
Imprints required on what?
-OTC and Rx oral dosage forms
-imprint identifies manufacturer and specific drug
5 aspects of risk mitigation for REMS
- Professional label and package insert
- MedGuide
- Communication plan
- Elements to assure safe use
-training of prescriber
-training of dispenser
-specify site of care
-pt show evidence of safe use
-pt agrees to be monitored - Implementation system- limits access and distribution of drugs with severe ADRs
Common drugs with REMS
-thalidomide, isotretinoin, pioglitazone, alosetron, Bosentan, clozapine, dofetilide, alendronate, Butrans, Epogen, fentanyl buccal mucosal or nasal, hydro morphine ER, mifepristone, oxy CR
Info on unit dose package
-generic and trade name (if appropriate)
-quantity of active drug (and # of dosage units if >1)
-name of manufacturer
-lot number
-expiration date
State law also includes Rph or provider who packaged it
Repackaged Unit dose vs multiple unit containers exp date (repackaged from bulk container or commercial drug)
Unit dose: 25% of remaining time b/w repack date and manufacturer exp date OR 1 yr (whichever is less
Multi-unit: manufacturer exp date or 1 yr whichever is less
Note: not expiration date=misbranding!
When is barcoding required
-pharmaceutical companies but not individual hospitals
-Doesn’t apply to samples
-does apply to single unit containers in hospital distribution systems
Bar code must contain NDC
Med pak
-Customized or med packs that have several solid dosage forms with directions
-requires same stuff as unit dose in addition to
-serial # for med pack
-rx serial # for each drug
-exp is 60 days from when med pack was prepared
Med watch
-reporting adverse events and product problems
-voluntary for healthcare professionals (FDA form 3500)
-mandatory for manufacturers, distributors, importers (FDA form 3500A)
Medical device problem reporting
Healthcare facilities are legally required to report suspected medical device related deaths to both FDA and manufacturers
Reporting vaccine adverse events
Ok what about veterinary products?
FDA/CDC Vaccine Adverse Event Reporting System (VAERS) NOT medwatch
FDAs center for veterinary medicine
Who is responsible for recall notification
-Manufacturer must send written recall notice to wholesalers and pharmacist for class I and II
-pharmacies must be aware of recalls (for class I retailers notify the physicians of consumers)
Levels most to least severe (wholesaler lvl—>retailer lvl—>consumer lvl)
Compounding: when is it ok?
-quantity reasonable for filling existing pt demand (estimated 30d supply)
-not be sold to other pharmacies of physician offices
-not available as commercial product
-must use approved ingredients
-can’t advertise specific drug products but can advertise that they specialize in compounding
-can’t make drugs that we’re withdrawn
-interstate distribution of compounded drugs is no more than 5% of total Rxs filled
-cannot compound copies of commercially available
-reconstitution of fda approved product is not compounding
-shouldn’t be compounding for office stock (considered manufacturing), this includes veterinary drugs
Expiration and BUDs for compounded products
-Non-aqueous solids: 6 month
-aqueous oral solutions: 14 days fridge
-aqueous topical: 30 days
——————————-/—/-/—————-
Revised:
-Non-preserved aqueous: 14 days
-Preserved aqueous: 35 days
-Non-aqueous oral liquids- 90 days
-Non-aqueous other forms- 180 days
Can a pharmacy be “FDA approved”
No this is misleading and inaccurate, may be registered with FDA but doesn’t mean they’re inspecting it
How are refills documented
On the back of the Rx or in a computer system
Who owns the Rx after dispensing?
-the pharmacy does and should refuse to return it to the pt but can make a copy
How long should pharmacies keep Rxs?
10 years
Prescription labeling reqs
-Top of label: pt name, Rx #, drug (generic and brand), strength, directions
-less critical info on bottom of label
-large familiar font (TNR 12 or arias 11)
-no acronyms
-is “2” instead of “two”
-avoid specifying exact times
-should include indications for med
-put label in pts language (drug name must also be in English)
-label should have prescribers name
-date
Exp for individual Rx dispensed by pharmacist
No federal law on this
State law also has no specific requirement
Products that need to be put in child resistant packaging?
-Rx drugs
-OTC CS
Follow non-Rx (OTC)
-aspirin
-NSAIDs
-methyl salicylate
-iron
-APAP
-Benadryl
-loperamide
-mouthwash
-lidocaine
-dibucaine
-fluoride
-minoxidil
-liquid nicotine
-ethylene glycol
-any non-Rx drug that used to be Rx (omeprazole, ranitidine)
-Note: single dose packs may be ok depending on the specific amount allowed be drug
-OTC with non safety cap should say “warning not for households with small children”
-prescriber can request non-safety cap on a one time basis
-pt can request non-safety cap on one time basis or ask for blanket waiver
-request may be written or verbal but Rph should document who made the request in event of lawsuit
-refill Rxs need new bottles and caps! (Can reuse bottle if it’s glass)
-reversible caps are discouraged
-don’t need child resistant when used inpatient in hospital
-obviously for non oral dosage forms it’s not required (e.g., inhaler)
Products exempt from poison prevention packaging act
-SL nitroglycerin
-SL/chewable isosorbide 10 mg max
-erythromycin ethylsuccinate granules
-erythromycin ethlysuccinate tabs 16g max
-anhydrous cholestyramine powder
-potassium in unit dose 50 meq max
-sodium fluoride 264 mg max
-betamethasone tabs in dispenser packs 12.6 mg max
-mebendazole 600 mg max
-Methylpred 84 mg max
-colestipol 5 gram max
-pancrelipase
-birth control in memory packs
-prednisone 105 mg max
-conjugated estrogen 32 mg max
-norethindrone 50 mg max
-medroxyprogesterone acetate tabs
-sacrosidase
-hormone replacement therapy
Goal of child resisted package
-<20% of children can open (<5 yrs) can open in 10 mins
->90% of adults (50-70 yrs) can open in 5 mins, then open a second time within 1 min
Federal anti-tampering act of 1982
Many OTC and cosmetics must have tamper resistant packaging with indication on labeling explaining how to tell if it’s been tampered with
Must be “tamper evident”
Patient package insert (PPI)
-must provide for certain drugs like Accutane, statins, or estrogen or progesterone products
-applies to all physicians, community pharmacies, and hospital pharmacies!!
-in hospital getting estrogen or progesterone hospital pharmacy must provide PPI before first dose then every 30 days (applies also to LTCF and nursing homes). Dispensed with every Rx in ambulatory setting
-PPI must contain: highlights section, table of contents, benefits and risks of drug, date of approval, toll free # and Internet address
-must give to it if they request (even if prescriber says not to give it)
Medguides
FDA requires them when:
-pt labeling could prevent serious ADRs
-high risk med relative to benefits
-pt adherence to directions is crucial
Med guides are
-prepared by manufacturer
-dispensed by pharmacist
-may be required to be dispensed as part of REMS
Must give medguide when:
-pt requests it (even if prescriber says not to give it)
-each time med is dispensed to a patient in the outpatient setting
-first time med is dispensed to provider for outpatient admin
-when medguide is change
-required by REMs
-notice: not required in inpatient setting unless pt requests it or required by REMS (different from contraceptive PPI)
Classes:
-anticonvulsants
-antidepressants
-anticoagulants
-anti diabetic meds
-NSAIDS
-opioids
-BZDs and Z drugs
Advair, naproxen, interferon, Ritalin, amiodarone, warfarin, fentanyl, pimecrolimus, selegiline, epzicom, teriparatide, isotretinoin, mefloquine, lexapro, lindane, alosetron, mifepristone, tamoxifen, NSAIDs, hydromorphkne, tacrolimus, ribavirin, infliximab, Lenalidomide, serevent, acitretin, atomoxetine, pramlitide, Bosentan, trizivir, nevirapine, onalizumab, sodium oxybate, abacavir, bupropion
Pharmaceutical equivalence vs therapeutic equivalence
Pharmaceutical: same active ingredient, dose, dosage form, route, strength/conc (different excipient ok)
Therapeutic: pharmaceutical equivalence and bioequivalence (same kinetics)
Pharmaceutical alternatives
Same therapeutic moiety but different salts, esters, dosage forms, strength
Can’t substitute these like you can generics
Product substitution vs therapeutic substitution
Product: generic interchange
Therapeutic: therapeutic interchange based on policy at hospital and their formulary (one statin for another)
Can you interchange if Rx has specific manufacturer listed
No, it’s the equivalent to writing for brand
When can you generic interchange
-A rated (bio equivalent)
-Can NOT interchange if B rated
-can’t interchange to a different dosage form (e.g., ointment to a cream)
-Must be same dose!
-AA, AN, AO, AP, AT all interchangeable just different DF
-AB mean prior issue have been resolved and are interchangeable
-further divided by AB1, AB2, AB3: and number must match to be interchangeable (AB1 int w/ another AB1 product but NOT an AB2)
-“RLD Yes” means it’s the reference product
-amino acids for TPN can be interchanged freely as long as % AA is the same
-certain drugs don’t have to be in orange book bc they’re grandfathered in
-can also use USP/DI vol III, facts and comparisons, FDA website
Allowable variation of actual drug strength compared to label
90-110%
Unless narrow therapeutic index then its 95-105% (digoxin, levothyroxine, phenytoin, warfarin, carbamazepine, lithium, cyclosporine, tacrolimus, theophylline, procainamide m, ethosuxamide
Can CS Rxs be mailed
-Yes all CS can be mailed
-inner container packaged and labeled correctly including name/address of pharmacy/dispenser
-plain outer container
Prospective DUR (Obra 90, req for state to receive federal money for their Medicaid program)
And other verification process info
Upon filling rx Rph make/update or profile including:
-name, address, phone #
-age/dob, sex, dx info, allergies, prior meds, Rph comments
-pt may refuse info-Rph to document and may refuse to fill Rx
Review the following:
-review meds for over or under utilization
-check therapeutic duplication
-incorrect doses or regimens
-offer to counsel
-must consider interactions w/OTC drugs and drugs filled at different pharmacy
-must document observations concerning therapy/decisions in record
-under WA: check for drug interactions and drug reactions as well
-WA required examination of medication record EACH time rx is processed
-Rph has duty to to take corrective action. Not required to contact MD in every case (may consult pt for “missing information”. Could use judgement to change DF in best interest of pt and tell MD later if not available)
Obra retrospective DUR
-another req for federal funding of Medicaid programs
-review of Rxs already dispensed
-DUR Board may recommend that some prescribing habits of MDs change or recommend educational programs
HIPAA
-healthcare facilities must provide written privacy notice explaining how info will be used/disclosed and how they can get access to the info (“This notice dea revived how medical information about you may be used and disclosed and how you can get access to this information.”)
-most require pt to sign an acknowledgement (signed form kept for 6 years after date sign or date of last fillled RX, whichever is later no req to resign again even after 6 years!!
-“notice of privacy practice” given to each NEW pt at pharmacy (if pt refuses to sign can still serve them but must document they tried to get signature). One time thing and only one needed per chain. Friends/relatives can p/u rx but NOT sign this form
-kids don’t need to sign, just the holder of the insurance
-retain for 6 yrs
-notice also posted in prominent
location and on website
-must provide notice if pt requests
-Permission must be granted for even spouse to get info on medical records
-telephone messages are ok to leave with relatives but can’t say the name of the drug or it’s use w/o pt permission
-weird bc it’s ok for friends or family to p/u Rx w/o prior permission
-note: hipaa does not confer a private right if action for individual patients
———————————————
-ok to use for TOP (consent not required)
-must get consent for anything else including marketing and research (unless it’s de-identified)
Importation and Reimportation of drug
Importation into US
-importer must demonstrate that foreign made drug meets FDA reqs (only allowed if by a firm registered with the FDA) and for approved drug
Reimportation
-drug shipped out of US then shipped back
-only legal if performed by the original manufacturer
Internet pharmacies
-Must display VIPPS seal (verified internet pharmacy practice sites)
-must register with DEA 30 days prior to business involving CS
-Monthly reports to DEA if dispensing at least 100 CS rx of 5000 CS dosage units
-statement on homepage includes: compliant w/ Act, contact info, PIC info/contact, licensed states, DEA registered, statement about requiring valid rx
Foreign Rxs
-unclear issue, seems may be ok, however NOT legal for CS
Can someone bring in Rx drug from outside the US or mail it in
FDA is flexible on it if:
-Can NOT be for CS
-intended use is unapproved and it’s for serious condition and effective tx isn’t available domestically
-drug won’t be distributed to others
-no unreasonable risk
-individual confirms in writing drug is for own supply (max 3 mo) and give name/address of MD in US responsible for their tx or gives evidence that it’s for continuation of tx started in other country
-drug can be shipped to pt, pharmacy, or MD
FDA can still seize drug or refuse it’s entry
Biosimilar price competition act applies to what else other than biosimilars ?
Vaccines
How often DEA registration must be renewed
Every 3 years
Does DEA registrant have to be an Rph?
No
Who can sign DEA forms ?
-the registrant or POA
-POA form must be signed by both people and does NOT expire
-person w/ POA does NOT have to be a pharmacist
Which places do not need a CS registration with DEA?
-warehouses for storing CS
-MD office where drugs are prescribed but NOT dispensed or administered
-common carriers (freight delivery companies for ex)
-places where SALES are made but no drug is on site
Time frame you can apply for reregistration with the DEA
-not more than 60 days prior to expiration
-if bulk manufacturers or importers than not more than 120 days
What must be on all CS commercial containers?
-must list the schedule (can use C, e.g., “CII”
-big enough to be seen w/o taking container off the shelf
Common schedule I drugs
-bufotenine
-diethylamide
-methaqualone
-heroin
-LSD
-marijuana
-mescaline
-peyote
Obscure CII drugs
-cocaine
-codeine
-levomethadyl
-meperidine
-nabilone
-dronabinol ORAL SOLUTION
-tincture of opium
-methamphetamine
-pentobarbital
-secobarbital
-phencyclidine
-propoxyphene
-phenmetrazine
List of schedule III drugs
-perampanel
-APAP/codeine
-anabolic steroids (“one”)
-benzphetamine
-buprenorphine
-butabarbital
-butalbital
-dronabinol
-nalorphine
-phendimetrazine
-compound or mixture containing amobarbital, secobarbital, pentobarbital combined with a non-control drug
-suppository of amobarbital, secobarbital, or pentobarbital
-gamma-hydroxybutyrate
-sodium oxybate
-codeine <1.8 g/100mL or <90 mg/dosage unit
-<300 mg dihydrocodeinone/100 mL or <15 mg/dosage unit
-<1.8 g dihydrocodeine/ 100 mL or <90 mg/ dosage unit
-<300 mg ethylmorphibe /100 mL or <15 mg/ dosage unit combined with non narcotic
-<500 mg opium/100 mL or per 100g or <25 mg/dosage unit
-<50 mg morphine/100 mL or per 100 g combined with non narcotic
Obscure schedule IV drugs
-suvorexant
-lorcaserin
-eluxadoline
-butorphanol
-Chloral hydrate
-carisoprodol
-chlordiazepoxide
-diethylpropion
-fenfluramine- DELETED!
-mazindol
-meprobamate
-modafinil
-pemoline
-pentazocine
-phenobarbital
-phentermine
-propoxyphene
-sibutramine
-tramadol
-zaleplon
-BZDs
-alfaxalone
-fospropofol
Schedule V
-APAP/codeine elixir
-promethazine/codeine
-diphenoxylate + atropine
-ezogabine
-lacosamide
-pregabalin
-brivaracetam
-not more than 200 mg of codeine per 100 mL or g
-not more than 100 mg ofdihydrcodeine per 100 mL or g
-not more than 100 mL of ethylmorphine per 100 mL or g
-not more than2.5 mg of diphenoxylate and not less than 25 mcg of atropine per dosage unit
-not more than 100 mg opium per 100 mL or g
- not more than 0.5 mg difenoxin and not less than 25 mcg atropine per dose unit
Drugs containing CS exempt from schedules
Phenobarbital products
-isuprel elixir
-Lufyllin-EPG elixir
-Donnatal tabs and elixir
-Anaspaz PB
Butabarbital products
-Pyridium plus
-butibel
Chlordiazepoxide (Librex caps)
Just about all of these have been removed from the market
Full list may be found at “exempt prescription products list”
Still a CS and need Rx but exempt from registration, labeling, refill limits, and record keeping requirements of CS
When is 222 not required
When transferring from a central fill pharmacy to a retail pharmacy
DEA form 222
-ordering C1 and C2s
-issued in envelopes containing 7 or 14 forms (each in triplicate)
-order more with 222a (ordered by registrant or person w/ POA)
-each has serial #
-only one item per line
-must note #of lines completed on bottom
-name/address if supplier entered in form
-sign and date
-POA can be obtained and must be maintained for as long as for forms containing their name and must be available for inspection
-POA can be revoked at any time by executing “notice of revocation” sign by person who authorized poa or successor
-copy 3 (blue) kept by purchaser
-copy 1 (brown) and 2 (green) supplier writes # of each item supplied and date shipped
-supplier keeps copy 1 (brown) and sends copy 2 (green) to DEA
-can partially fill order and fill rest within 60 days (form is valid for 60 days from being filled out by supplier)
-purchaser record on copy 3 the # packages received for each item and date received
-supplier can endorse order to another if can’t fill it (must endorse entire order) write name and address of second supplier and signature on back of copy 1 and 2. Second supplier ship to purchaser
-if purchaser wants to cancel part or all of order then notify supplier in writing and the supplier will draw a line through the item and write “cancelled” in the “shipped” column
-max 10 items per form
-if registration terminates unused order forms should be returned to DEA
Who gets which copies of 222 form
-copy 3 (blue) kept by purchaser
-copy 1 (brown) and 2 (green) supplier writes # of each item supplied and date shipped
-supplier keeps copy 1 (brown) and sends copy 2 (green) to DEA at the end of the month
Unaccepted 222 forms
-must not fill order of form not done correctly or any alterations or erasure marks
-Return copy 1 and 2 to purchaser with statement why
-supplier can also not accept and order for any reason, and just sent a statement saying it’s not accepted. Purchased attach statement with all copies and retain in records
Lost/stolen 222
-fill out new form with statement that goods not received bc form lost
-retain an copy of statement with copy 3 or new and old form and send copy to supplier with copy 1/2
-if supplier later received original they write “Not accepted” and return copies to purchaser who retains with copy 3
-must immediately report loss to DEA with serial # of form
-if it’s supplier they must report at least date and name/address of purchaser
-if entire book lost must report date of issuance
-if found must immediately report to DEA
How long to keep 222 copies
-2 years
For which drugs must supplier maintain 222 separately from other order forms and records?
Storage reqs for these drugs
-etorphine, carfentanil, diprenorphine
Must be stored in a safe or steel cabinet equivalent to US government class V security container
Advantages of controlled substance ordering system (CSOS)
Other info
-can order CII-CV AND non-controls
-no line item limit for a single order
-faster and more accurate
-decreased cost
Other info:
-must acquire digital certificate and private key for signatures for signing electronic orders. Public key must validate signature.
Info to include on C1-2 order:
-unique tracking # (last 2 digits of year, X, 6 characters, e.g., 25X123456)
-DEA #
-supplier name, address, DEA #
-date order signed
-drug name/strength or NDC, quantity in each pack and # of packs
Supplier must:
-verify integrity if signature and ensure digital certificate is not expired or on the revocation list
-retain e-copy of order with # of containers supplier and date
-can fill remainder of partial orders within 60 days (expires after that, same as 222)
-supplier cannot endorse order to another supplier (unlike 222)
-supplier must send e-copy of order to DEA within 2 business days
-purchaser create record of quantities received and date and retain with e-copy
-like with 222: if can’t be filled supplier send statement of such with reason why, or can refuse to accept for any reason and just need a statement saying so (purchaser link this stuff to original)
-supplier may void full order: “void” on e-copy and send back (supplier does NOT need to retain copy but purchaser does), or part of order by indicating nothing shipped for each item voided
-neither purchaser nor supplier may correct a defective order
-lost order treated same as 222 except purchaser also send tracking #
Purchaser and supplier must maintain records for 2 years
When can pharmacy compound CS
-for “office use” I.e., if selling to other registrants must be a manufacturer
-aqueous, oleaginous, or solid DF
-doesn’t contain more than 20% CS
-only distributed to practitioner authorized to dispense
Can an employee or agent communicate a CS Rx to pharmacy?
Yes
And they can prepare it but the prescriber must sign it
Can and MD write an rx to be filled for the purpose of general dispensing to patients?
Nope- he must order them from a supplier
I.e, no rx for office use
Can you write and Rx for oxy for detox or maintenance
No, must be a drug approved by FDA for that indication
Self prescribing CS
AMA states “physicians should generally not treat themselves or members of their immediate family” and makes exceptions for emergencies (this is policy not law, federal law is not specific)
So not a super clear answer
Washington says no
Electronic prescribing of CS
-need third party auditor or approved certification body approve the program
-identity proofing- two factor authentication (something you know, have (token), or are (biometric), or digital certificate
-you can print a copy of an e-Rx but must be done only after it’s transmitted otherwise system should not allow it to be sent. Must say “copy only-not valid for dispensing”
-Can NOT sign for mx patients with one signature but CAN sign mx RX for the same pt w/ one signature
-signing and sending to pharmacy can be done separately
-if it fails to send an intermediary can NOT fax it, must be printed by the prescriber and faxed (and say e-transmission failed), for C3-5
-must retain records electronically for 2 years
-if also received at paper or oral rx for same script must write either that one or e-version void
Backing up files and rx storage
-Pharmacy application service providers must back up files daily
-e-rx must be stored electronically and paper rx via paper record
-CS records kept x2 yrs
Emergency verbal Rx for C2
-Prescribers agent CANNOT call it in, must be prescriber
-quantity is limited to amount needed for emergency
-immediately reduce to worrying
-Rph makes effort to identify MD (c/b # etc.)
-MD deliver hardcopy within 7 day (or postmarked within 7 days if mailed) or must call DEA
-hardcopy says “authorization for emergency dispensing” and date of verbal order. Rph attach to verbal rx
-central fill pharmacies not permitted to do this
Emergency:
-immediate administration is needed for proper Tx
-no appropriate alternative
-not reasonably possible to provide written rx in time
Partial filling of a C2?
And for terminally I’ll?
C3-5?
-can NOT be done bc pt requests- no longer true!!
-MD or pt (not representative) can request partial over phone or in person, with remainder filled within 30 days of date written!
-document if request was from pt or MD
-can be done if out of stock
-write quantity on face of rx
-fill remainder within 72 hrs or will need new rx after that (for OOS)
-if pt doesn’t want or can’t pay for full quantity
-if pharmacy attempting to confirm validity
For terminally Ill or in nursing home/LTCF pt:
-must confirm terminal illness and document on rx “terminally ill” or “LTFC”
-on BACK of rx: date of partial, quantity, remaining quantity, Rph
-fill remainder within 60 days
C3-5:
-partially filling ok if recorded like a refill
-doesn’t exceed total quantity dispensed or 6 months
_____________________________________
- OOS- remainder in 72 h or NOTIFY MD IF CANNOT; document quantity dispensed
- 72 H OF PARTIAL FILL DATE
- pt/MD request- remainder in 30d (no limit to amount of partial fills)
- 30 D OF ISSUED DATE
- LTCF w/ terminal illness- remainder in 60 d
- 60 D OF ISSUED DATE!
CS refill records
-enter refills on back of rx or another readily retrievable document or electronically
-following info retrievable:
-drug name and dose
-date filled or refilled
-quantity
-Rph initials
-total # refills
-if Rph initials and dates back of rx it’s assumes full quantity was refilled
-pharmacy must have downtime procedure if normally done electronically
CS refill printout or logbook
-Rph must verify and sign print out of each days CS refill data (signed by each Rph involved)
-print out should be available to pharmacy within 72 hours from date of refill
-alternative could use bound log book in which Rph signs statement each day attesting to refill data
-either option must be kept for 2 years
-sign at end of each shift
Note: a central record keeping location must be capable of sending print out to pharmacy within 48 hours
When do CS labeling reqs not apply
-ultimate user is institutionalized AND
-not more than 34 day supply or 100 units (whichever is less) dispensed
-med is not in possession of the ultimate user
-proper safeguards and records
-system is adequate to identify the supplier, product, patient, directions, and cautionary statements
C3-5 Rx transfer
-one time basis unless shared real time database
-communicated b/w Rph (or intern)
Sending pharmacy
-“VOID” on rx or indicate transfer for electronic rx
-on BACK record:
-name and address of pharmacy
-DEA # of pharmacy
-pharmacist receiving
-also record date and name of sending Rph
Receiving pharmacy
-“Transfer” on face
-record:
-original date and original refill #
-date first dispensed
-remaining refills
-dates/locations of prior refills
-pharmacy name, address, DEA
-Rx number
-transferring Rph name
-create record w/ receiving Rph name
Schedule V OTC sales
-must be done by Rph
-240 mL (8 oz) or 48 dose units max for opium containing products (per 48 hours)
-120 mL (4oz) max or 24 dose units for any other products (codeine) per 48 hours)
-age 18+
-ID
-record book including:
-name and address
-name and quantity of drug
-date
-Rph
-maintain record book for at least 2 yrs
-central fill pharmacy not included
Washington aligns with this!
CS at central fill pharmacies
Retail sending it must:
-write “Central fill” on Rx along with name, address, and DEA of central fill pharmacy
-write name of retail Rph
-write date
-indicate refills dispensed and remaining
-keep original rx for 2 yrs from date of last fill
-record receipt of filled rx, delivery method, and person receiving
Central fill pharmacy must:
-keep copy of rx (fax or electronic record of pharmacy name, address, dea)
-record date or receipt of rx and name of Rph filling it
-record date of deliver and delivery method
Destruction of CS
-reverse distributor fills out 222 for transfer then 41 sent to dea for actual destruction of CS
-222 only used for c2
Transferring CS b/w pharmacies
-may transfer up to 5% of total dosage units dispensed in a calendar yr otherwise need to register as a distributer (unless it’s bc it’s going out of business)
-222 must be used if C1 or C2
-other CS document: drug name, strength, DF, quantity, date and name, address, and DEA # of each party
Transfer of CS when pharmacy going out of business
-222 used for c1 and c2
-other CS document: drug name, strength, DF, quantity, date and name, address, and DEA # of each party
-transferring pharmacy do complete inventory (also serves as initial inventory for receiving pharmacy), don’t need to send to DEA but new pharmacy must maintain all records for 2 yrs
Prescriber CS record keeping
Must keep records for:
-drugs dispensed
-CS administered for detox or maintenance
Do NOT need to keep records for:
-CS administered (other than above)
-CS prescribed
Inventory records and inventory requirements
-keep inventory records for 2 yr
-C2 separate and C3-5 separate or readily retrievable
-can use recording device but must promptly transcribe
-include ALL CS (including not yet picked up rx, in warehouse, etc.)
-financial and shipping records can be stored offsite at central location if DEA is notified
-Inventory must be dont upon opening or closing for the day and must be indicated on the inventory
-inventory done one first day of business (even if it’s zero) and then at least every 2 years
-also inventory a drug if it becomes CS or changes schedules
-exact counts for unopened bottles
-exact counts for C1 or C2
-exact counts for any CS bottle holding >1000 tabs
-estimate counts for C3-5 (<1000 tabs)
Who can’t be employed by pharmacy?
-can’t employ someone with felony hx w/ CS or had DEA registration denied/revoked
-could get waiver from DEA with lots of strict reqs and details including last offense, current activities, proposed access to CS, safeguards etc.
Procedure for theft of CS
-Immediately upon discovery report directly to DEA
-any “significant” loss (err on side of caution)
-complete form 106- send original and a copy to DEA and keep another copy
-should contact local police
-if discovered that there’s no loss or theft the don’t need to submit form 106 and can notify DEA of this in writing
-break/spillage is not “loss” so use for 41 instead
Note: if shipment never reaches pharmacy the supplier is responsible, if Rph signs for it they are responsible
DEA form for breakage, damage, or spillage, of CS
41
When should there be federal investigation of pharmaceutical theft or robbery?
->$500
-person killed or significant injury
-interstate or foreign commerce is involved
Exportation if CS
-attorney general permits re-exportation of c1-4 to other countries if being shipped to DEA permit/license holder and DEA notified within 30 days
Pseudoephedrine limits
-3.6 grams per day
-9 grams per 30 day period
-solid forms must be in blister packs with max 2 doses per blister pk
-mail order max 7.5 g per 30 days
-must be behind counter (front counter ok too) or locked in display case
-don’t need a pharmacy to sell PSE
-log book: name, address, date/time, signature (verified against gov ID), name of product and quantity, “notice false statement subject to criminal penalty”
-don’t need logbook if single sales of no more than 60 mg PSE
-hold logbook entry for 2 yr
-retailer must submit self certification to attorney general that staff are trained
Note: non-Rx phenylpropanolamine is not available on US or Canada
Note: These reqs are for Non-prescription sales
Methadone rules
-no prescribing for addiction(duh)
-initial dose must not exceed 30 mg
-total dose for day 1 must not exceed 40 mg unless MD documents that 40 mg wasn’t enough
-prescriber can administer methadone to relieve acute withdrawal symptoms while arranging for tx program (max one day at a time, max 3 days)
-Hospital may also give methadone to prevent withdrawal
Take home limits:
-pt can take home single dose for days when clinic is closed
-day 0-90: 1 dose per week
-day 91-180: 2 doses per week
-day 181-270: 3 doses per week
-day 271-365: 6 doses per week
-after 1 yr: 2 week supply max
-after 2 yr: one month supply but must make monthly visits
OTC label
-active ingredient (including amounts)
-inactive ingredients
-uses
-purpose (basically drug class “antihistamine”)
-warnings
-directions
-other info
If any above info is missing it’s misbranded
Will generally also have:
-exp date, lot, name and address of manufacturer, net quantity, what to do if overdose
Also needs “DRUG FACTS”:
7 point label:
-name
-name and address if manufacturer, packager, distributor
-net contents
-active ingredients and quantity of certain other ingredients
-name of any habit forming drug
-cautions and warnings
-directions for use
FAERS
-FDA adverse event reporting system
-receives reports form medwatch
-reporting is voluntary for healthcare professionals but mandatory for manufacturers
-used by CDER and CBER to monitor safety of products
What special warnings must be on OTC labels
-“pregnant or nursing seek advice from MD”
-“especially important not to use in last 3 months of pregnancy” (for some drugs including aspirin)
-list sodium content if >5 mg per dose and if daily dose is >140 mg must say “ask MD if on sodium restricted diet”
(Can be “sodium free” if <5 mg, or “very low sodium” if <35 mg, or “low sodium” if <140 mg)
-label indicate if:
-calcium 20+ mg/dose
-magnesium 8+ mg/dose
-potassium 5+ mg/ dose
-label warning for pts with electrolyte restricted diet if
-sodium: 140+ mg/ day
-calcium: 3.2 grams/ day
-magnesium: 600 mg/ day
-potassium: 975 mg/day
Reclassification of OTC to rx (4 methods)
-full NDA
-supplemental NDA
-FDA may grant exception
-Nonprescription drug advisory committee may recommend (would categorize it as category 1 (generally recognized as safe and effective “GRASE”)
-category 2 (NOT generally considered safe/effective)
-category 3 (insufficient data to permit classification)
-Notice 2 is worse than 3!
Federal refill limit for OTC
None I don’t think, so if no refill instructions are written can refill as many times unless state has restriction on time or refills (so double check on state law for this)
Tamper evident package exemptions
-aerosol products
-non-rx products not accessible to general public (used in hospitals)
-lozenges and drugs in first aid kits
-1 piece hard gelatin caps..
Dietary supplement health and education act
-for health foods, food supplements, herbals, amino acids, vitamins, minerals
-don’t need to prove efficacy (FDA can challenge and prove not effective)
-just reasonable assurance that there’s no unreasonable risk
-still has GMP guidelines but manufacturer runs its own tests
-manufacturer keep records for 1 yr past exp or 2 yrs after distribution
-company providing dietary ingredient doesn’t need to follow GMP unless directly packaging and selling that ingredient, manufacturer of supplement must ensure quality
Statement must be on herbal and dietary supplements
“These claims not evaluated by FDA. This product is not intended to diagnose, tx, cure, or prevent any dx”
Ephedra and ephedrine alkaloids
Banned from dietary supplements, ban doesn’t apply to RX, non-rx drug products, conventional foods like herbal teas, or traditional Chinese medicine
Homeopathic drugs
-listed in homeopathic pharmacopoeia of United States
-must meet usual labeling requirements
-English name is required (not just Latin)
-I’d also listed in USP/NF must meet these stricter requirements
-must use GMP
-so not need expiration date
Cosmetics
-don’t have to meet GMP but needs to be sanitary
-don’t specifically have to be tested for safety, but if safety hazard they are considered misbranded
-labels must list ingredients in descending order of predominance (often “water” is first)
-coloring agents must be excepted for use or it’s adulterated
-ingredients must be in USP/NF or CTFA (cosmetic ingredient dictionary)
-perfumes and flavoring oils can be listed by name (rather than ingredient)
-many need to be in tamper resistant packaging (vaginal or mouthwash)
Sunscreen innovation act of 2014 goal is to speed approval of new sunscreen ingredients by FDA
Form ATF-11
For pharmacy to buy 95% ethanol for compounding
ATF-1446
-Purchase of tax free alcohol
-Use is for medicinal or scientific use in or tx
-may not be sold or loaned to other pharmacies or md office
-may not be sold to outpatients
-need running inventory
-stored in locked fire resistant store room
American with disabilities act
-covers business employing 15+
-protects alcoholics but not drug addicts
-protects HIV +, mental retardation, paralysis, epilepsy
Drug free workplace
Must inform employer within 5 days if convicted of criminal possession of drugs
Federal regulations for LTCF
-Residents drug therapy must be free from unnecessary drugs
-limit use of psychotropic drugs
-facility must employ Rph or consultant Rph
-each residents drug regimen must be reviewed every 30 days
Drug quality and security act
-reinstate 503a
-establish outsourcing facilities (exempt from NDA and labeling reqs, but subject to GMP)
-establish 10 year timeline for track and trace drug supply chain security
-3 pieces of documentation for lawful distribution of drug-pharmacy don’t accept drug unless these are provided:
-transaction hx
-transaction information
-transaction statement
-pharmacy maintain above info for 6 years
In response to NE meningitis
Ryan haight act
Internet pharmacies
-no dispensing CS unless at least one in Persian physical exam in last 24 months
-register with DEA if CS involved
Compounding pharmacy (503A) vs outsourcing facility (503B)
-pharmacy needs rx outsourcing doesn’t
-outsourcing needs to follow GMP not pharmacies
-outsourcing facility cannot wholesale
-outsourcing facility must be registered with FDA not pharmacies
USP 797 labeling reqs
-name of preparation
-internal ID #
-BUD
-initials of compounder
-storage requirements
Are you required to sign your name across a C2?
No, not anymore
New requirement after removal of x waiver
At time of DEA registration renewal demonstrate completion of relevant training (at least 8hrs for non-physicians)
FYI: can’t use pain products (mono product, sublicaide, etc) for maintenance since this is diversion! (You CAN give combo product for pain!)
Give with medguide
Part 2 rule
-privacy rule for narcotic tx programs
-distinct from HIPAA
-unlike hipaa, cannot disclose info to other providers UNLESS written consent has been provided
-Farm bill
-CBD oil
-Epidiolex (cannabidiol)
-Legalized cultivation and interstate transfer of hemp (must be <0.3% THC)
-CBD like from hemp is legal but from marijuana is CS
-now non-controlled but used to be c5 (used for seizures)
