Sept. 17, 2013
Chapter 4
The Closed System of
Controlled Substance
Distribution
1
History of CS Drug Control
• Class Discussion……
• Separate Slides
2
Federal Controlled Substances Act
(CSA)
Actual Name of Act is:
“Federal Comprehensive Drug Abuse Prevention
and Control Act of 1970”
Mostly cited as CSA (Controlled Substance Act)
• Creates a closed system via registration
• Establishes national uniformity
• Enforced by DEA
3
State v. Federal Authority
• State law must be stricter than federal law
to not conflict
• Pharmacists should follow stricter law
• DEA generally has a close relationship with
state pharmacy boards
• Presumption of interstate commerce in the
federal regulation of controlled substances
4
Definition of Narcotic in the Act
-Natural or synthetic opium or
opiates or derivatives, and also
includes cocaine (by legal definition,
not medical definition) which is not
an opiate derivative
-This would exclude Adderall,
Concerta, methylphenidate, etc.,
from the definition of narcotic
5
Classification Of Controlled
Substances
• Placement into one of 5 schedules depending upon
abuse potential and degree to which drug may cause
physical or psychological dependence.
• Schedule I drugs have no accepted medical use (under
the act) as opposed to the drugs in the other schedules
• Exceptions: GBH (gamma hydroxybutyric acid – the
“date rape drug” Xyrem®), Schedule I except for the only
approved GBH (Xyrem®) which is in Schedule III and
available from only one pharmacy in the country.
6
C-I Drugs & Medical Marijuana
• Includes hallucinogenics such as LSD, peyote, mescaline
marijuana. Also includes heroin and unapproved GHB.
• Marijuana for medical purposes legal in some states (state
law)
• Courts have held that there is no constitutional right of
patients to obtain marijuana. Schedule I under FEDERAL LAW
• U.S. Supreme Court held that federal agents can seize
medical marijuana because of a presumption of interstate
commerce
• U.S. Supreme Court held that marijuana buying
cooperatives violate the CSA
• Federal court held the government could not take action
against physicians who recommend medical marijuana
7
C-II Drugs
• High potential for abuse and abuse may
lead to severe physical or psychological
dependence
• Includes opium and other opiates,
cocaine; stimulants such as amphetamine
and methamphetamine; depressants
such as amobarbital, glutethimide and
seconal and pentobarbital
8
C-III Drugs
• Lesser potential for abuse than C-II drugs and abuse may lead to
moderate or low physical dependence or high psychological
dependence
• Includes many C-II drugs in combination with a noncontrolled
ingredient, or in smaller dosages, or in a less abusable dosage
form. For example: the barbitals in suppository form; codeine
and hydrocodone with aspirin, acetaminophen or ibuprofen
• Also includes certain stimulants; anabolic steroids, dronabinol,
ketamine, paregoric and GHB approved by the FDA
• Strength limit of 1.8 g of codeine per 100 ml (c.f., limit different in
Schedule V). Also strength limits for dihydrocodeinone, opium,
morphine and other drugs
9
C-IV Drugs
• Lower potential for abuse than C-III drugs and
abuse may lead to limited physical or
psychological dependence.
• Includes narcotic drugs such as propoxyphene
(no longer available) depressants such as
alprazolam, chloral hydrate, barbital,
benzodiazepines; stimulants such as
diethylpropion, phentermine.
10
C-V Drugs
• Low potential for abuse relative to C-IV drug and
abuse may lead to limited physical or
psychological dependence relative to C-IV drugs
• Includes antitussives containing codeine and
antidiarrheals containing an opiate.
• Strength limits of 200 mg of codeine per 100 ml,
100 mg of dihydrocodeine or opium per 100 ml,
1.5 mg of diphenoxylate and not less than 25
mcg atropine per dosage unit
11
Authority For Scheduling
• Scheduling authority vested in the attorney general,
however, must request scientific and medical
evaluation of the drug and recommendation from
secretary of DHHS.
• Recommendation of secretary regarding scientific and
medical issues are binding on AG, except when AG
finds drug must be placed in a C-I to avoid an
imminent hazard to public safety if not otherwise
listed (e.g., bath salts).
• Scheduling decision must be based upon several
factors (p. 176)
12
Manufacturer Labeling & Packaging
• Labels and labeling of commercial
containers of controlled substances
must contain identification symbol of
the schedule.
• Symbol must be prominently located
• E.g., CII, CIII, CIV (usually number
within the “C”)
13
Registration
• Anyone who manufactures, distributes or dispenses
controlled substance (among others) must register
with DEA
• Manufacturers and distributors must register
annually. Dispensers every 3 years
• Exemptions from registration include agents or
employees of registrants, common carriers, ultimate
users, prescribers and dispensers in the service of the
U.S. government, and law enforcement officers
14
Definitions (Reg=DEA Regulations, Stat=CSA statute)
•
Reg Individual practitioner means a physician, dentist, veterinarian, or other individual licensed,
registered, or otherwise permitted, by the United States or the jurisdiction in which he/she
practices, to dispense a controlled substance in the course of professional practice, but does not
include a pharmacist, a pharmacy, or an institutional practitioner.
•
Reg Institutional practitioner means a hospital or other person (other than an individual) licensed,
registered, or otherwise permitted, by the United States or the jurisdiction in which it practices, to
dispense a controlled substance in the course of professional practice, but does not include a
pharmacy.
•
STAT (21) The term “practitioner” means a physician, dentist, veterinarian, scientific investigator,
pharmacy, hospital, or other person licensed, registered, or otherwise permitted, by the United
States or the jurisdiction in which he practices or does research, to distribute, dispense, conduct
research with respect to, administer, or use in teaching or chemical analysis, a controlled substance
in the course of professional practice or research.
•
STAT (10) The term “dispense” means to deliver a controlled substance to an ultimate user or
research subject by, or pursuant to the lawful order of, a practitioner, including the prescribing and
administering of a controlled substance and the packaging, labeling or compounding necessary to
prepare the substance for such delivery. The term “dispenser” means a practitioner who so delivers
a controlled substance to an ultimate user or research subject.
•
Reg Dispenser means an individual practitioner, institutional practitioner, pharmacy or pharmacist
who dispenses a controlled substance.
15
Definitions – what it means…
• What the definitions mean:
• A pharmacy is a practitioner
• A pharmacist is a practitioner but CAN NOT prescribe (unless
state authorizes)
• A pharmacy is a practitioner but NOT an individual practitioner
• A pharmacy is a dispenser
• A pharmacist is a dispenser
• An individual practitioner is a dispenser
• An individual practitioner is not an institutional practitioner
• An institutional practitioner is a dispenser
• Dispensing is delivering, prescribing and administering (so if an
individual prescribes or administers a controlled substance
he/she is also “dispensing” (i.e., prescribing IS dispensing)
16
Individual Practitioners (IPs)
• Individual practitioners include physicians,
dentists, veterinarians or others licensed to
dispense by the state
• IPs who are agents or employees of another IP may
administer or dispense controlled substances, but not
prescribe
• IPs who are agents or employees of a hospital or other
institution may administer, dispense and prescribe
controlled substances provided all requirements are met
including that the institution has assigned a specific
internal code number to the IP as a suffix to the
institution’s DEA number. [NOTE: DEA & Suffix Must be
on RX]
17
Activities Requiring Registration
Manufacturing, distributing, reverse
distributing, dispensing, conducting
research, conducting narcotic
treatment program, conducting
chemical analysis, importing,
exporting
18
Dispensing
• Definition of dispense includes to deliver a CS pursuant
to the lawful order of a practitioner. Dispense includes
prescribing, administering and dispensing.
• Definition of practitioner includes physician, dentist,
veterinarian, scientific investigator, pharmacy,
pharmacist, hospital or others licensed by their
jurisdiction to be involved with controlled substances
• Definition of institutional practitioner includes hospitals,
but not pharmacies
• Midlevel practitioners may register as dispensers
provided that state law authorizes independent or
collaborative prescriptive authority
19
Manufacturing
• Means the production, preparation, compounding or
processing of a drug, as well as packaging, repackaging, labeling
or relabeling
• Activities of practitioners incidental to dispensing are excluded
• Manufacturer coincidental activities include distributing its own
products, chemical analysis and preclinical research
• Pharmacies exempt if engaged in the ordinary course of
pharmacy practice.
• Pharmacy may manufacturer and distribute to other
practitioners aqueous or oleaginous solution or solid dosage
form of a narcotic not exceeding 20% narcotic concentration.
(Compare to FDA compounding requirements which place limits
on pharmacies or they are deemed manufactures and must
register as such.)
20
Distributing
• Definition: to deliver a CS OTHER than by administering or
dispensing
• Wholesalers register as distributors
• Practitioners registered to dispense are exempt provided they
comply with all conditions:
– distributed to another registrant, proper records (invoice for Ciii ,iv ,v and
222 form for Cii), and not more than 5% of total controlled substances
distributed AND dispensed within a 1 year period [the 5% rule].
• Return of CSs to suppliers by practitioners is exempt provided
record keeping requirements are met
• Distributors required to design and operate a system able to
detect suspicious orders of CSs and inform DEA upon discovery
21
Conducting Research
• Coincidental activity of dispensers
to conduct research with
schedule II – V CSs if authorized.
• Research with C-I drugs requires
submission of protocols with
application
22
Separate Registrations Required
 Each principal place of business where CSs are
administered, dispensed or stored requires
separate registration
 For practitioners, if separate location in same
state but only “prescribing” and not
administering or storing, no separate
registration – but yes if other state.
23
Distribution of Controlled Substances on
Discontinuance of Business
• On discontinuance of business without transfer of business,
registrant must return certificate of registration to DEA for
cancellation, together with any unexecuted 222 forms.
– Controlled substances must be disposed of
pursuant to regulations
• 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 and C-II products must be recorded via
Form 222.
24
Security Requirements
• All applicants and registrants must provide effective
controls and procedures to guard against theft and
diversion
• DEA considers several factors when evaluating the overall
security system of a registrant or applicant
• Individual practitioners must securely lock CSs in a
substantially constructed cabinet
• Pharmacies and institutional practitioners may do the
same or disperse them throughout stock of non
controlled substances
• May not employ any person whose application for
registration has been denied or revoked
25
Penalties
• §841 establishes penalties for drug traffickers and is
applicable to practitioners who prescribe and/or
dispense outside of the ordinary course of professional
practice
• §842 establishes penalties for practitioners for not
conforming to the requirements of the CSA, such as
recordkeeping. The standard was changed from strict
liability to negligence
• 222 form violations are subject to fines of up to $30,000
and up to 4 years in prison
• Knowingly or intentionally possessing a CS other than by
a valid Rx could result in up to 1 year in prison and a fine
of up to $1,000
26
DEA Inspections
• DEA has the authority to inspect any place where CS records
are kept or persons are registered
• Allowed to examine and copy all records and reports, inspect
within reasonable limits and take an inventory of CSs
• Without consent of owner or PIC, inspector not allowed to
inspect financial, sales (other than shipping), or pricing data.
• Audit procedure involves inspecting the records of drugs
received less drugs dispersed and comparing with inventory
• Prior to inspection, inspector required to state purpose of
inspection and present owner or PIC with credentials and
written notice of inspection
27
Notice of Inspection (NOI)
• NOI must contain name of owner or PIC, name
and address of business, date and time of
inspection and a statement that the NOI was
given
• Inspector must obtain a written statement of
informed consent signed by PIC or owner
• Consent must be voluntary and not coerced and
may be withdrawn at any time during the
inspection
• PIC or owner can grant inspector limited consent
28
Administrative Inspection Warrant (AIW)
• No consent required
• Probable cause requirement
– Valid public interest
– Very low standard including large purchases of CS,
need to ensure compliance with recordkeeping,
substantial period of time since last search
• Contrasted to probable cause for search warrant (SW) which
requires evidence that a crime has been or will be committed
on the premises; or that evidence of a crime exists at the
premises
• AIW created by Supreme Court as an alternative to SW
• AIW may only be served during regular business hours
• When it must be served
• Several exceptions exist as to when a warrant is not required
29
State Pharmacy Board Inspections
• Some states allow warrantless searches of
pharmacies
• State warrantless search statutes may be
constitutional provided:
• the business is licensed
• the industry is “pervasively regulated”
• the licensee’s expectation of privacy is outweighed
by government interests of protecting the health
safety and welfare
• the statute carefully limits time, place and scope of
inspections
30
Practical Considerations During an
Inspection
• Pharmacists with nothing to fear should not fear routine
inspections and should be cordial and cooperative.
• If inspection is not routine, PIC should contact owner and
perhaps attorney if necessary.
• If DEA agents have a warrant, cannot refuse inspection
• If state inspectors do not have a warrant, whether consent is
required depends upon state law
• Pharmacists should never lie and generally best to say as
little as possible if inspection is not routine.
• Pharmacists should document what is said and done and not
sign anything he/she does not understand
31
Opioid Treatment Programs (OTPs)
• Congress first authorized narcotic treatment programs (now
OTPs) in 1974
• Only LAAM, methadone, buprenorphine SL and
buprenorphine-naloxone are authorized drugs for treatment
of opioid addiction
• Detoxification defined as dispensing an opioid agonist in
decreasing doses incident to withdrawal
• Maintenance defined as dispensing of opioid agonist for a
period in excess of 21 days
• A compounder is a person who engages in maintenance or
detoxification and mixes, prepares, packages or changes
dosage form of a narcotic drug.
32
Methadone
• Used for severe pain outside of narcotic treatment
programs
• Not legal to prescribe or dispense as an antitussive
• APhA lawsuit established that FDA could not restrict
distribution of methadone
• 40 mg methadone tablets now restricted to OTPs
voluntarily by manufacturers
33
DATA
(Drug Addiction Treatment Act, 2000)
• DATA enacted in 2000 with intent of allowing addicts to be treated
for addiction in office based settings (outside of OTPs)
• Only drugs permitted are buprenorphine SL (Subutex) and
buprenorphine-naloxone (Suboxone) tablets
• Treatment must be by a “qualifying physician”
• Qualifying physician may not treat more than 100 patients (30
initially then after 1 year can apply for up to 100 patients)
• Subutex intended for beginning treatment and likely will be
administered by prescriber. Pharmacists should verify any subutex
Rxs and refuse to dispense Rxs for an addict being treated for
addiction from more than one physician
• “Usual course of practice”: can not prescribe narcotics for addict
detox or maintenance, only through OTPs or DATA waived
registration. If OTP: LAAM,Methadone, Subutex, Suboxone (NOT
orther opiates), if DATA waived: only Subutex or Suboxone.
34
Controlled Substance Registrant
Protection Act
• Purpose of law to make it a federal crime if
robbery results in $500 or greater replacement
cost of CSs, or person suffers “significant” injury,
or interstate commerce is involved in the
planning or execution of the crime.
• Penalties of up to 20 years’ imprisonment,
$25,000 fine or both. If weapon is used the
penalties are higher. If death results, the penalty
is higher yet.
35
Anabolic Steroids Act of 2004
• Amends prior anabolic steroid legislation enacted
to prevent misuse in order to enhance athletic
performance
• Maintains anabolic steroids as schedule III
• Adds several steroids to the Act
• Provides for automatic scheduling of certain salts,
ester and ethers of anabolic steroids without need
to prove muscle growth
36
Combat Methamphetamine
Epidemic Act of 2005
• Purpose of Act to place restrictions on OTC drugs used to manufacture
methamphetamine
• Drugs regulated include ephedrine, pseudoephedrine, and
phenylpropanolamine
• These drugs are called “scheduled listed chemical products.”
• Law limits sale to no more than 3.6 gms of ephedrine, PSE, or PPA base to a
single purchaser per day.
• No consumer may purchase more than 9 gms within a 30 day period, or 7.5
gms within a 30 day period by mail order.
• Products must be stored behind counter or in a locked cabinet where
customers do not have direct access.
• Sales must be recorded with required information
• Employers must train each employee who sells the drugs
37
Methamphetamine Production
Prevention Act of 2008
• Intended to modify the Combat Meth Act by facilitating
and encouraging the use of electronic logbooks in an
effort to stop “smurfing”
• Although electronic logbooks are not required it is hoped
that they will become the standard and that pharmacies
will participate in common electronic logbooks
• Sellers can now capture information by bar code reader
• Seller or purchaser may enter the purchaser’s name,
address and date and time of sale.
• Seller may collect the purchaser’s signature by any of
three means
38
U.S. Postal Laws
CSs may be mailed provided they
meet the packaging standards
established by the U.S. Postal Service
39
Next time
CHAPTER 5
40