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Federal Controlled substances act
- creates a closed system via registration
- establishes national uniformity
- enforced by DEA
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State law vs federal law
- state must be more strict than federal for no conflict
- pharmacists should follow more strict law
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Class I Drugs
- Hallucinogens LSD, peyotek mescaline marijuana
- gov. can not take ation against physicians that recommend medical marijauna.
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Class II drugs
- high abuse potential
- severe physical or psych. dependance
- opium and other opiates
- cocaine
- amphetamines
- amobarbital, pentobarbital and glutethimide
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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
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Strenght limits of class III drugs
- 1.8g codeine per 100 ml
- also limits for dihydrocodeinone, opium, morphine and others
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Class IV Drugs
- lower potential for abuse than CIII
- limited physical or psych dependance
- dextropropoxyphene, benzos, chloral hydrate, barbital, diethylpropion, phentermine
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Class V drugs
- low abuse potential
- antitussives and antidiarrheals
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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
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Scheduling authority is vested in
- the attorney general
- must request scientific evaluation of the drug and recommendation from secretary of DHHS
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Labels and labeling of commercial containers of controlled substances
- must contain identification symbol of the schedule
- symbol must be prominently located
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Must register with DEA
anyone who mfg, distributes or dispenses controlled substances
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manufacturers and distributors must register with the DEA every
year
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Dispensors must register with the DEA every
3 years
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Activities that require registration with the DEA
- mfg, dist, reverse dist
- dispensing
- conducting research/chemical analysis
- narcotic treatment programs
- importing/exporting
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IPs who are agents or employees of another IP may
- administer or dispense controls
- may not prescribe
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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 #
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Definition of dispensing
- deliver a CS per order of a practitioner
- includes prescribing, administering and dispensing
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institutional practitioner
hospitals but not pharmacies
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mid level practitioners
may register to dispense provied that state law authorizes independent collaborative prescriptive authority
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Manufacturing
- activities of practitioners incidental to dispensing are excluded
- pharmacies exempt if engaged in ordinary course of pharmacy practice
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distributing
- deliver a CS
- wholesalers register as distributors
- practitioners are exempt
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return of CS to suppliers by practitioners
exempt from having to liscense as a distributor as long as record keeping requirements are met
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Distributors are required to
design and operate a system able to detect suspicious orders of CSs and inform DEA upon discovery
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Conducting research on 2-5
dispensers allowed to conduct research if authorized
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research on C1 drugs
requires submission of protocols and application
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Separate registrations are required for
each place of business where CS are administered dispensed or stored.
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current registrants wshould receive registration renewal
60 days before expiration and must contact DEA if not recieved 45 days before expiration
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Dispenser registration form
- DEA form 224
- available online
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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
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Wheter a registration can be transferred upon sale of business might depend on wheter the business is
- sole proprietorship
- partnership
- corporation
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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
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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
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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
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All applicants and registrants mus provide
effective controls and procedures to guard against theft and diversion
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Individual practitioners must
securely lock CSs in a substantial cabinet
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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
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Pharmacy Inspections
- requires issuance of search warrent based on probable cause
- any evidence obtained in violation of the fourth amendment will not be admissible
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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
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DEA inspectors are not allowed to
inspect financial, sales other than shipping or pricing data without consent of the owner
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prior to inspection, inspector is required to
- state purpose of inspection
- present ownder or PIC with credentials
- provide a written notice of inspection
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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
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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
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Administrative inspection warrent
- no consent required
- probable cause requirement
- no criminal evidence required
- may only be served during regular business hours
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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
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State board of pharmacy inspections
some states allow searches without warrents
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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
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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
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If DEA agents have a warrent
cannot refuse inspection
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Authroized fo treatment of opioid addiction
- LAAM
- methadone
- buprenorphine SL
- buprenorphine/naloxone
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Detoxification is defined as
dispensing an opioid agonist in decreased doses incident to withdrawl
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Maintenance defined as
dispensing opioid agonist for a period in excess of 21 days
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Compounder
person who engages in maintenance or detox and mixes, prepares, pkg or changes dosage form of a narcotic drug
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Methadone
- used or severe pain
- not legal for cough
- 40mg tabs restricet to OTPs voluntarily by mfg
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Drugs permited under DATA
- buprenorphine SL or buprenorphine/naloxone
- must be under qualifying physician
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Qualifying OTP physicians
may not treat more than 100 patients
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Pharmacist should verify
- OTP treatment drugs
- refuse to dispense if addict being treated for addiction from more than one physician
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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.
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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
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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
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Electronic log books
- not required
- info captured by barcode reader
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