Law Chapter 4

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Law Chapter 4
2011-10-08 12:20:20
Law Chapter

Law Chapter 4
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  1. Federal Controlled substances act
    • creates a closed system via registration
    • establishes national uniformity
    • enforced by DEA
  2. State law vs federal law
    • state must be more strict than federal for no conflict
    • pharmacists should follow more strict law
  3. Class I Drugs
    • Hallucinogens LSD, peyotek mescaline marijuana
    • gov. can not take ation against physicians that recommend medical marijauna.
  4. Class II drugs
    • high abuse potential
    • severe physical or psych. dependance
    • opium and other opiates
    • cocaine
    • amphetamines
    • amobarbital, pentobarbital and glutethimide
  5. Class III Drugs
    • less potential for abuse than class II
    • moderate physical dependance, high psychological
    • barbiturates in suppository form
    • codein or hydrocodone with ASA, APAP or IBU
    • anabolic steroids, dronabinol, ketamine, paregoric and FDA approved GHB
  6. Strenght limits of class III drugs
    • 1.8g codeine per 100 ml
    • also limits for dihydrocodeinone, opium, morphine and others
  7. Class IV Drugs
    • lower potential for abuse than CIII
    • limited physical or psych dependance
    • dextropropoxyphene, benzos, chloral hydrate, barbital, diethylpropion, phentermine
  8. Class V drugs
    • low abuse potential
    • antitussives and antidiarrheals
  9. Class V drug limits
    • 200mg codeine per 100ml
    • 100 mg of dihydrocodeine or opium per 100 ml
    • 1.5 mg diphenoxylate and not less than 25 mcg atropine per dosage unit
  10. Scheduling authority is vested in
    • the attorney general
    • must request scientific evaluation of the drug and recommendation from secretary of DHHS
  11. Labels and labeling of commercial containers of controlled substances
    • must contain identification symbol of the schedule
    • symbol must be prominently located
  12. Must register with DEA
    anyone who mfg, distributes or dispenses controlled substances
  13. manufacturers and distributors must register with the DEA every
  14. Dispensors must register with the DEA every
    3 years
  15. Activities that require registration with the DEA
    • mfg, dist, reverse dist
    • dispensing
    • conducting research/chemical analysis
    • narcotic treatment programs
    • importing/exporting
  16. Individual practitioners
    • physicians
    • dentists
    • vets
  17. IPs who are agents or employees of another IP may
    • administer or dispense controls
    • may not prescribe
  18. IPs who are agents of a hospital or other institution may
    • administer
    • dispense
    • prescribe
    • as long as the institution has a suffix # for that IP to tack onto the DEA #
  19. Definition of dispensing
    • deliver a CS per order of a practitioner
    • includes prescribing, administering and dispensing
  20. institutional practitioner
    hospitals but not pharmacies
  21. mid level practitioners
    may register to dispense provied that state law authorizes independent collaborative prescriptive authority
  22. Manufacturing
    • activities of practitioners incidental to dispensing are excluded
    • pharmacies exempt if engaged in ordinary course of pharmacy practice
  23. distributing
    • deliver a CS
    • wholesalers register as distributors
    • practitioners are exempt
  24. return of CS to suppliers by practitioners
    exempt from having to liscense as a distributor as long as record keeping requirements are met
  25. Distributors are required to
    design and operate a system able to detect suspicious orders of CSs and inform DEA upon discovery
  26. Conducting research on 2-5
    dispensers allowed to conduct research if authorized
  27. research on C1 drugs
    requires submission of protocols and application
  28. Separate registrations are required for
    each place of business where CS are administered dispensed or stored.
  29. current registrants wshould receive registration renewal
    60 days before expiration and must contact DEA if not recieved 45 days before expiration
  30. Dispenser registration form
    • DEA form 224
    • available online
  31. Modification, transfer or termination of registration with the DEA
    • modifications must be approved by DEA
    • registration terminated upon death of licensee
    • registration cannot be assigned or terminated w/o DEA approval
  32. Wheter a registration can be transferred upon sale of business might depend on wheter the business is
    • sole proprietorship
    • partnership
    • corporation
  33. On discontinuance of business without transfer of business registrant must
    • return certificate of registration to DEA for cancellation, together with any unexecuted 222 forms
    • CSs must be disposed of pursuant to regulations
  34. If registrant wishes to transfer business, proposal must be submitted to DEA at least 14 days prior to transfer with required information
    • transfer may occur unless DEA notifies otherwise
    • Complete inventory of CSs must be taken on date of transfer
    • C2 products must be recoreded on Form 222
  35. Attorney General may
    • deney practitioner applicant
    • suspend or revoke registration to mfg, distribute or dispense upon finding that applicant materially falsified application, has been convicted of a felony or has had a state license suspended, revoked or denied
  36. All applicants and registrants mus provide
    effective controls and procedures to guard against theft and diversion
  37. Individual practitioners must
    securely lock CSs in a substantial cabinet
  38. Pharmacies and institutional practitioners may
    • lock CS in a cabinet
    • disperse throughout stock of non-controlled substances
    • not emply any person whose application for registration has been revoked or denied
  39. Pharmacy Inspections
    • requires issuance of search warrent based on probable cause
    • any evidence obtained in violation of the fourth amendment will not be admissible
  40. DEA inspection
    • DEA has authority to inspect any place where CS records are kept or people are registered
    • allowed to examine and copy all records
    • allowed to take inventory
  41. DEA inspectors are not allowed to
    inspect financial, sales other than shipping or pricing data without consent of the owner
  42. prior to inspection, inspector is required to
    • state purpose of inspection
    • present ownder or PIC with credentials
    • provide a written notice of inspection
  43. Notice of inspection must contain
    • name of owner or PIC
    • name and address of business
    • date and time of inspection
    • statement that NOI was given
  44. Inspector must obtain
    • written statement of informed consent signed by PIC or owner
    • must be voluntary and not coerced
    • may be withdrawn at any time during inspection
    • PIC can grant limited consent
  45. Administrative inspection warrent
    • no consent required
    • probable cause requirement
    • no criminal evidence required
    • may only be served during regular business hours
  46. AIW probable cause requirement
    • valid public intrest
    • low standards including large purchases of CS
    • ensure compliance with recordkeeping
    • substantial period of time since last search
  47. State board of pharmacy inspections
    some states allow searches without warrents
  48. warrentless state board inspections may be constitutional provieded:
    • business is licensed
    • industry is pervasively regulated
    • licensee's expectation of privacy is outweighed by government interests of protecting health safety
    • statute limits time place and scope of inspection
  49. If inspection is not routine PIC should
    • contact owner and perhaps attorney if necessary
    • never lie
    • say as little as possible
    • document what is said and done and not sign anything he/she does not understand
  50. If DEA agents have a warrent
    cannot refuse inspection
  51. Authroized fo treatment of opioid addiction
    • LAAM
    • methadone
    • buprenorphine SL
    • buprenorphine/naloxone
  52. Detoxification is defined as
    dispensing an opioid agonist in decreased doses incident to withdrawl
  53. Maintenance defined as
    dispensing opioid agonist for a period in excess of 21 days
  54. Compounder
    person who engages in maintenance or detox and mixes, prepares, pkg or changes dosage form of a narcotic drug
  55. Methadone
    • used or severe pain
    • not legal for cough
    • 40mg tabs restricet to OTPs voluntarily by mfg
  56. Drugs permited under DATA
    • buprenorphine SL or buprenorphine/naloxone
    • must be under qualifying physician
  57. Qualifying OTP physicians
    may not treat more than 100 patients
  58. Pharmacist should verify
    • OTP treatment drugs
    • refuse to dispense if addict being treated for addiction from more than one physician
  59. Anabolic steroid act
    • prevent misuse in enchancement of athletic performance
    • maintains anabolic steroids as schedule 3
    • automatic scheduling of salts, esters and other forms of anabolic steroids whenter they cause muscle growth or not.
  60. Combat methamphetamine act
    • restriction of OTCs used to make meth
    • ephedrine, pseudoephedrine, phenylpropanolamine
    • sheduled listed chemical producs
    • sales must be recoreded
    • employers must train employee who sells
    • product must be behind the counter or in a locked cabinet
  61. law limts sale of meth drugs to
    • no more than 3.6g per person per day
    • no more than 9g w/in 30 days
    • no more than 7.5g w/in 30 days by mail order
  62. Electronic log books
    • not required
    • info captured by barcode reader