Sept. 17, 2013Chapter 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

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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.

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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

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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

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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

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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.

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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)

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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]

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Activities Requiring Registration

Manufacturing, distributing, reverse distributing, dispensing, conducting research, conducting narcotic treatment program, conducting chemical analysis, importing, exporting

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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.

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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

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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

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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

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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

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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

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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

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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.

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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

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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.

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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.

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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

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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

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U.S. Postal Laws

CSs may be mailed provided they meet the packaging standards established by the U.S. Postal Service

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Next time

CHAPTER 5

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