oct 5th chapter 4 - the closed system of controlled substance distribution

federal controlled substances act

• Creates a closed system via registration

• Establishes national uniformity

• Enforced by DEA

state vs federal authority

• State law must be stricter than federal law to not conflict.

• Pharmacists should follow stricter law.

• The DEA generally has a close relationship with state pharmacy boards.

• Presumption of interstate commerce in the federal regulation of controlled substances

definition of narcotic

natural or synthetic opium or opiates or derivatives including cocaine, which is not an opiate derivative

classification of controlled substances

• Placement into one of five schedules depending on abuse potential and degree to which drug may cause physical or psychological dependence

C-I drugs

• No accepted medical use, as opposed to drugs in the other schedules

• High potential for abuse and lack accepted information on safety of use

• Includes hallucinogenics, some opiates, methaqualone, and unapproved GHB

medical and recreational use of marijuana

• Marijuana for medical purposes: legal in many states and in a few states for recreational use, as well

• Marijuana remains a C-I drug under federal law.

• Federal courts have held that there is no constitutional right of patients to obtain marijuana.

• The U.S. Supreme Court held that federal agents can seize medical marijuana because of a presumption of interstate commerce.

• The U.S. Supreme Court held that marijuana buying cooperatives violate the Controlled Substance Act (CSA).

• Federal court held that government could not take action against physicians who recommend medical marijuana.

C-II drugs

• High potential for abuse and abuse may lead to severe physical or psychological dependence

• Includes opium and many other opiates (including products containing hydrocodone); cocaine; stimulants such as amphetamine and methamphetamine; depressants such as amobarbital, glutethimide, secobarbital, and pentobarbital

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

• 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. Also, strength limits for dihydrocodeinone, opium, morphine, and other drugs

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 dextropropoxyphene; depressants such as alprazolam, chloral hydrate, barbital, benzodiazepines; stimulants such as diethylpropion, phentermine; tramadol

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 more than 25 mcg atropine per dosage unit

authority for scheduling

• Scheduling authority is vested in the attorney general who must request a scientific and medical evaluation of the drug and recommendation from the secretary of DHHS.

• The recommendation of the secretary regarding scientific and medical issues is binding on AG, except when AG finds the drug must be placed in C-I to avoid an imminent hazard to public safety.

• The scheduling decision must be based on several factors.

manufacturer labeling and packaging

• Labels and labeling of commercial containers of controlled substances must contain the identification symbol of the schedule.

• The symbol must be prominently located.

registration

• Anyone who manufactures, distributes, or dispenses controlled substances (among others) must register with the DEA.

• Manufacturers and distributors must register annually; dispensers must register 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.

individual practitioners (IPs)

• Individual practitioners (IPs) include physicians, dentists, veterinarians, or others licensed to dispense by the state.

• IPs who are agents or employees of another IP (other than a mid-level) 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.

activities requiring registration

• Manufacturing, distributing, reverse distributing, dispensing, conducting research, conducting narcotic treatment programs, conducting chemical analysis, importing, and exporting

dispensing

• Definition of dispense includes to deliver a controlled substance (CS) pursuant to the lawful order of a practitioner; 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

• Mid-level practitioners (including pharmacists) may register as dispensers, provided that state law authorizes independent or collaborative prescriptive authority.

manufacturing

• Manufacturing: production, preparation, compounding, or processing of a drug; also, packaging, repackaging, labeling or relabeling

• Excludes activities of practitioners, incidental to dispensing

• Manufacturer coincidental activities include: distributing its own products, chemical analysis, and preclinical research

• Pharmacies are exempt if engaged in the ordinary course of pharmacy practice.

• A pharmacy may manufacturer and distribute to other practitioners aqueous or oleaginous solution or solid dosage form of a narcotic not exceeding 20% narcotic concentration.

distributing

• Distributing: to deliver a CS

• Wholesalers must register as distributors.

• Practitioners registered to dispense are exempt, provided they comply with all conditions.

• Stocking of ADS in LTCF and return of CSs to suppliers by practitioners are exempt, provided recordkeeping requirements are met.

• Distributors (and now all registrants) required to design and operate a system able to detect suspicious orders of CSs and inform DEA upon discovery

• Controversy whether delivery to patient’s prescriber is distributing or dispensing

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.

separate registrations required

• Each principal place of business where CSs are administered, dispensed, or stored requires separate registration.

application for registration and reregistration

• May not engage in activity where registration is required until registration is granted and certificate of registration issued.

• Current registrants should receive emails reminding of registration expiration.

• The dispenser registration form is DEA Form 224, which is online, and renewed online.

modification, transfer, or termination of registration

• Any modifications must be approved by the DEA.

• If registrant dies or ceases legal existence, the DEA must be notified, and the registration terminated.

• Registrations cannot be assigned or terminated without DEA approval.

distribution of controlled substances on discontinuance of business

• On discontinuance of business without transfer of business, the registrant must return a certificate of registration to the DEA for cancellation together with any unexecuted Form 222s.

  • Controlled substances must be disposed of pursuant to regulations.

• If the registrant wishes to transfer business, a proposal must be submitted to the DEA at least 14 days prior to the transfer with required information.

  • The transfer may occur, unless DEA notifies otherwise.

  • A complete inventory of CSs must be taken on the date of transfer.

  • C-II products must be recorded via Form 222.

denial, revocation, or suspension of registration

• The attorney general may deny a practitioner applicant a registration if it is determined not to be in the public interest, which requires the consideration of five factors.

• The AG may suspend or revoke a registration to manufacture, distribute, or dispense upon finding that the applicant materially falsified an application; has been convicted of a felony; or has had a state license or registration suspended, revoked, or denied.

security requirements

• All applicants and registrants must provide effective controls and procedures to guard against theft and diversion.

• The 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 the stock of noncontrolled substances.

• May not employ any person whose application for registration has been denied or revoked

penalties

• Section 841 establishes penalties for drug traffickers and is applicable to practitioners who prescribe and/or dispense outside of the ordinary course of professional practice.

• Section 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.

• Form 222 violations are subject to fines of up to tens of thousands of dollars 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.

pharmacy inspections

• Constitutional issues

  • The Fourth Amendment protects individuals from unreasonable searches and seizures.

  • Requires the issuance of a search warrant based on probable cause

  • The exclusionary rule provides that any evidence obtained in violations of the Fourth Amendment will not be admissible.

DEA inspections

• The DEA has the authority to inspect any place where CS records are kept or persons who 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 person in charge (PIC), inspector not allowed to inspect financial, sales (other than shipping), or pricing data

• The audit procedure involves inspecting records of drugs received less drugs dispersed and comparing with inventory.

• Prior to inspection, the inspector is required to state the purpose of inspection and present the owner or PIC with credentials and written notice of inspection.

notice of inspection (NOI)

• The NOI must contain the name of the owner or PIC, name and address of the business, date and time of inspection, and a statement that the NOI was given.

• The inspector must obtain a written statement of informed consent signed by the PIC or owner.

• Consent must be voluntary and not coerced and may be withdrawn at any time during the inspection.

• The PIC or owner can grant the inspector limited consent.

administrative inspection warrant (AIW)

• No consent required

• Probable cause requirement

  • Valid public interest

• Contrast to probable cause for search warrant (SW)

• AIW created by Supreme Court as alternative to SW

• AIW may only be served during regular business hours.

• Several exceptions exist as to when a warrant is not required.

state pharmacy board inspections

• Some states allow warrantless searches of pharmacies.

• State warrantless search statutes may be constitutional, provided certain requirements are met.

practical considerations during an inspection

• Be cordial and cooperative.

• If inspection is not routine, the PIC should contact the 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.

• Never lie and generally best to say as little as possible

• Document what is said and done and do not sign anything not understood.

opioid treatment programs (OTPs)

• Congress first authorized narcotic treatment programs (now OTPs) in 1974.

• Only LAAM, methadone, buprenorphine, and buprenorphine containing products are authorized drugs for treatment of opioid addiction.

• Practitioners wanting to conduct maintenance or detox treatment must be registered by the DEA.

methadone

• Used for severe pain outside of narcotic treatment programs

• Not legal to prescribe or dispense as an antitussive

• The American Pharmacists Association (APhA) lawsuit established that the FDA could not restrict the distribution of methadone.

• Manufacturers voluntarily restricted 40 mg methadone tablets to OTPs.

DATA

• Enacted in 2000 with intent of allowing addicts to be treated for addiction in office-based settings (outside of OTPs)

• Currently, only permitted drugs are buprenorphine products

• Treatment must be by a “qualifying practitioner”

  • DEA number and state authorized to prescribe

  • As of 2023 — NO DEA X NUMBER NEEDED

  • As of 2023 — NO PATIENT LIMITS

  • Goal: Increase in practitioners that can treat OUD patients, even pharmacists if states allow

controlled substance registrant protection act

• The purpose of the law is 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 can result in up to 20 years of imprisonment, $25,000 fine, or both. If a weapon is used, the penalties are higher. If death results, the penalty is higher yet.

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, esters, and ethers of anabolic steroids without need to prove muscle growth

combat methamphetamine epidemic act of 2005 and methamphetamine prevention act of 2008

• Places restrictions on OTC drugs used to manufacture methamphetamine including pseudoephedrine

• The law limits sale to no more than 3.6 g of ephedrine, PSE, or PPA base to a single purchaser per day.

• No consumer may purchase more than 9 g within a 30-day period or 7.5 g within a 30-day period by mail order.

• The products must be stored behind the counter or in a locked cabinet where customers do not have direct access.

• Sales must be recorded with required information.

• Many states have stricter laws.

methamphetamine production prevention act of 2008

• 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 barcode reader.

• The seller or purchaser may enter the purchaser’s name, address, and date and time of sale.

• The seller may collect the purchaser’s signature by any of three means.

• Sellers must annually engage in self-certification.

US postal laws

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