Regulation of Controlled Substances

Chemical Diversion and Trafficking Act of 1988

Places under federal control 20 chemicals and the tableting and encapsulation machines that are known to be used in the illegal manufacture of controlled substances

THREE TYPES OF RECORD KEEPING

RECORDS OF INVENTORY RECORDS OF DRUG RECEIVED RECORDS OF DRUGS DISPERSED

A NARCOTIC SCHEDULE III MAY NOT CONTAIN MORE THAN

1.8 or codeine or dihydrocodeine per 100 ml, or not more than 90 mg per dosage unit 300 mg of dihydrocodeinone and ethylmorphine per 100 ml, or hot more than 15 mg per dosage unit 500 mg of opium per 100mL or per 100g, or not more than 25mg per dosage unit 50mg of morphine per 100mL or per 100 g IF IT CONTAINS MORE THAN THESE PARAMETERS THEN IT WILL BE CONSIDERED A SCHEDULE II

SCHEDULE V CANNOT CONTAIN MORE THAN

200 MG OF CODEINE PER 100ml or 100g 100mg of dihydrocodeine, ethylmorphine or opium per 100mL or 100g 2.5 mg of diphenoxylate and not less than 25mcg of atropine sulfate per dosage unit 0.5mg of difenoxin and not less than 25mcg of atropine sulfate per dosage unit if it contains more than these parameters, then it may drop to CIII,CIV, CV

INSTITUTIONAL PRACTITIONER

A HOSPITAL or other person licensed, registered, or otherwise permitted, by the US or the jurisdiction in which it practices, to dispense a controlled substance in the course of professional practice, DOES NOT INCLUDE A PHARMACY

Narcotic

A natural or synthetic opium or opiate and any derivative EX: poppy straw, coca leaves, cocaine, ecgonine

Records of Theft or Loss

A pharmacy that discovers the theft or significant loss of controlled substances must notify the nearest DEA office and local police a report must then be made on DEA FORM 106 which is available online at the DEA's website IF THE TRUCK GETS ROBBED--> the WHOLESELLER MUST sign the DEA 106, it is not the pharmacy's responsibility because they haven't received the drug if the pharmacy signs for the drugs but never received it--> Pharmacy has to fill out DEA FORM 106 (MAKE SURE TO DOUBLE CHECK ALL THE TIME)

Administrative inspection Warrant

AIW rather than a search warrant, law enforcement officer must show probable cause for a judge to issue AIW, much easier to satisfy PIC may not refuse consent, refusal will cost $25,000 or imprisonment for 1 year probable cost is defined as "valid public interest" large purchases of controlled substances need to ensure compliance with record keeping passage of a substantial period of time since the last inspection may be served during REGULAR HOURS must be completed in resonable manner Search Warrant MAY BE SERVED DAY OR NIGHT

DEA INSPECTOR

ALLOWED TO EXAMINE and copy all records and reports, to inspect the premises within reasonable limits, and to take an inventory of the controlled substances before an inspection, the inspector is required to state the purpose of the inspection and present to the owner or pharmacist in charge the agent's credentials and a written notice of inspection UNLESS the owner or pharmacist in charge consents in writing, the inspector is not allowed to inspect financial date, sales date other than shipment data or pricing data in a normal audit, the inspector examines the records of the amount of drugs received and the records of the amounts of drugs dispensed

DEA verification by the Pharmacist

Add 1,3,5 postion Add 2,4,6 positionX2 ADD the SuM there are many forgers so in reality Pharmacist can't solely rely to this method for the validity of the controlled substance prescription M for a midlevel practitioner P or R for distributor

Suboxone

Buprenorphine-nalozone tablets expected prescriptions in community pharmacy the nalaxone is added to deter people from crushing and injecting the tablets

Authority for Scheduling

CSA grants the Attorney General of the US the authority to place unscheduled drug into a schedule, place a scheduled drug into a different schedule or remove a drug from scheduling determination must be based on the record after opportunity of hearing

Federal Comprehensive Drug Abuse Pevention and Control Act of 1970

Controlled Substance Act CSA THREE TITLES: TITLE I: ESTABLISHED REHABILITATION PROGRAMS FOR DRUG ABUSERS TITLE 2: registration and distribution of CS TITLE 3: importation and exportation of controlled substances

form use for RECORD OF THEFT OR LOSS

DEA FORM 106

FORM USE FOR ORDERING CONTROLLED SUBSTANCES

DEA FORM 222

FORM USE FOR RECORD OF RECEIPT FOR CONTROLLED SUBSTANCE

DEA FORM 222

FORM USE FOR RECORDS OF DISPERSAL

DEA FORM 222

form use for distribution from of controlled substance form one pharmacy to another

DEA FORM 222

form use for disposal or destruction of controlled substances

DEA FORM 41

FAXED PRESCRIPTION OF SCHEDULED II

DEA regulations permit the limited use of faxed prescription as another exception to the requirements that pharamcists may only dispense schedule II drugs pursuant to an ACTUAL WRITTEN PRESCRIPTION No guarantee that the patient will come in you can use the fax to prepare the RX for the patient but the patient still need to bring a hard copy faxed can only be accepted if: it is to be compounded for the direct administration to a patient by parental, IV, IM, subcutaneous, or intraspinal infusion, resident of a long term care facility enrolled in a hospice certified Medicare Title XVIII program, practitioner must note on the prescription that the patient is a hospice patient

ACTIVITIES REQUIRING REGISTRATION for dispensers

DISPENSING MANUFACTURING DISTRIBUTING CONDUCTING RESEARCH

DISPENSING

Dispense= control substance for later use PRACTITIONER INSTITUTIONAL PRACTITIONER MIDLEVEL PRACTITIONER

MAINTENANCE TREATMENT

Dispensing of an Opioid agonist treatment medication at stable dosage levels for a period in excess of 21 days, in the treatment of an individual for opioid addiction over 21 days

CAUTIONARY STATEMENT

FOR SCHED II,III,IV drugs the label should include a CAUTIONARY STATEMENT "CAUTION: Federal law prohibits the transfer of this drug to any person other than the person for whom it was prescribed IF YOU PUT THE CAUTION LABEL IN SCHED V, IT IS MISBRANDED

FAXED PRESCRIPTION OF SCHEDULED II

Fax: straight from the doctor to pharmacy HANDHELD DIVICE: DOCtor to 3rd party, then to pharmacy, THESE COMPANIES MUST REGISTER FOR CERTIFICATION WITH DEA as of right now, ONLY 1 COMPANY IS CERTIFIED, electronic prescriptions are considered oral prescription

DETOXIFICAITON TREATMENT

HIGHER TO LOWER DOSE (dispensing of opiod in decreasing doses such as METHADONE); They don't give a euphoric effect and longer half-life Methandone is used for pain and not for DETOX ALLEVIATE ADVERSE PHYSIOLOGICAL OR PSYCHOLOGICAL EFFECTS SUCH AS WITHDRAWALS METHOD TO BRING THE INDIVIDUAL TO A DRUG FREE STATE under 21 days

FED LAW REQUIREMENT FOR LABELING SCHEDULE II,III,IV,V PRESCRIPTION

INITIAL FILLING (BY FED LAW) PHARMACY NAME AND ADDRESS SERIAL NUMBER OF THE PRESCRIPTION NAME OF THE PATIENT NAME OF THE PRESCRIBER

Records of receipts

INVOICES are acceptable receipts for Schedules III, IV,V the DEA FORM 222 is acceptable for Schedule I, II

DEA ORDER FORM 222 EXECUTION

If order can't be filled entirely, it can be partially fill and supply the balance with in 60 DAYS ONCE ORDER IS RECEIVED, the purchaser record in Copy 3 the number of containers received of each item and the date received. failure to do so could result in substantial penalty and lead to extensive controlled substance audit supplier will not accept any form that shows any alteration, erasure or changes if the purchaser makes an error, it is necessary to void and file all three copies of the form, then make another order form.

SCHEDULE IV

LOW POTENTIAL FOR ABUSE relative to the drugs or other substances in Schedule III accepted medical use in treatment in the US abuse lead to limited physical dependence or psychological dependence relative to the drugs or other substance in Schedule II VALIUM, XANAX, BENZODIAZAPENS

SCHEDULE V

LOW POTENTIAL FOR ABUSE relative to the drugs or other substances in Schedule IV accepted medical use in US abuse of drug may lead to limited to physical dependence or psychological dependence relative to drugs or other substance in Schdule IV antidiarrheal and cough syrup; glycenephen with codeine

The comprehensive Methamphetamine Control Act of 1996

Law regulates the sale of large amounts of OTC ephedrine, pseudoephedrine and phenylpropanolamine (Scheduled Listed Chemical Products) products that have been purchased to be a s a precursor chemical to manufacture methamphetamine; the law does not regulate ordinary OTC sales of the above named products 3.6 grams per day 9.0 grams for 30 day period 7.5 for a 30 day period in mail order 60mg or less don't need to be recorded in the logbook

Classification of Controlled Substances

NARCOTIC NONNARCOTIC FIVE SCHEDULES under Federal law

MANUFACTURING

NEEDS TO REGISTER WITH DEA Makes a product to sell for a later use means that production, preparation, propagation compounding, or processing of a drug, either directly or indirectly, either by extraction from natural origin or by chemical synthesis packaging, repackaging, labeling or relabeling coincidental activity are CHEMICAL ANALYSIS, PRECLINICAL RESEARCH PHARMACIES don't have to register as long as they don't exceed 20% of a narcotic substance (CSA). If they compound and distribute a product to other practitioners (FDA)

TRANSFERING PRESCRIPTION INFORMATION

NO LIMIT FOR SCHEDULES CIII,IV,V IN federal law one time basis only of transfers if state allows transfer requirements for transferring pharmacist void out remaining refills transfer requirements for receiving pharmacist needs hard copy CANNOT TRANSFER SCHEDULE II Marinal is the active ingredient in MARIJUANA IT USED TO BE CII not its CIII If it is a shared computer system--> transfer can be done until no refills remaining--> if separate systems, it can only be transfer once

MIDLEVEL PRACTITIONER

NURSE PRACTITIONER MIDWIVES NURSE ANESTHETISTS CLINICAL NURSE SPECIALISTS PHYSICIAN ASSISTANT most recently the DEA recognized that in some states PHARMACISTS who are engaged in collaborative practice agreements may register as mid-level practitioners, they have the authority to administer, initiate, and modify drug therapy in accordance with collaborative practice requirements not engaged in prescribing don't need to be registered

Refills

No Schedule III or IV prescription may be filled or refilled more than 6 months after the date of issuance of the prescription or more than FIVE TIMES THESE RESTRICTION DO NOT APPLY TO SCHEDULE V PRESCRIPTION DRUGS CIII AND CIV EXPIRES IN 6 MONTHS IN FED LAW CV HAS NO EXPIRATION IN FED LAW CII do not have official expiration date under federal law, just until the patient no longer needs it ALWAYS PUT THE DATE OF ISSUANCE not the date of dispensing--> if you don't change the date to date of issuance, the computer amy allow you one extra refill than the actual expiration--> VIOLATION OF DEA CONTROLLED SUBSTANCE ACT as long as the number of tablets dos not exceed the amount prescribed, and the prescription has not expired, the CIII and CIV may be dispensed more than 5 times (typically in cases of partial fills)

INTERNET PRESCRIPTIONS

PHARMACISTS RESPONSIBILITY prescriptions prescribed and dispensed pursuant to online surveys--> NO GOOD must have a valid patient to physician relationship where physicians has seen patient at least 1 YEAR

Partial Filled CII but "UNABLE TO SUPPLY"

PHARMACY IS OUT OF STOCK Pharmacist is not absolutely certain the the prescription is legitimate: must either fill the entire amount or not dispense the prescription at all; in this instance the pharmacist could partially fill the prescription even if the drug is in stock while waiting for verification Large amount and patient could not pay for the entire amount, or did not want the entire amount

Partial Filling of Scheduled II prescription

Pharmacist can partial fill, not the prescription and the balance of the prescription amount must be filled with in 72 hours; if the pharmacist was not able to fill the prescription with in this time frame, he or she needs to notify the doctor (ONLY BILL THE INSURANCE ON THE AMOUNT THAT YOU HAVE) it may be partially filled for LTCFs (long term care patients) and patient with a medical diagnosis of TERMINAL ILLNESS but no longer than 60 DAYS FROM THE DATE OF ISSUANCE; PHARMACIST MUST RECORD THAT THE PATIENT IS terminally ill or LTCFs CII DOES NOT HAVE EXPIRATION DATE FOR FED LAW

Orally or Electronically transmitted Prescription of CII (EMERGENCY SITUATION IN WHICH CII MAY BE DISPENSED UPON)

Pharmacist in most cases can't take oral prescription they can only take it if it is an EMERGENCY SITUATION:HAVE TO MEET ALL OF THREE CRITERIAS: Immediate administration of controlled substance is medically necessary for the proper treatment of the intended ultimate user no appropriate alternative treatment available that is not a CII not reasonably possible for the prescribing practitioner to provide a written prescription to be presented to the person dispensing the controlled substance prior to the dispensing

DISTRIBUTION FROM A PHARMACY TO ANOTHER PHARMACY of schedule CII

The PURSHASER must execute a DEA form 222

QUALIFIED PHYSICIANS FOR OTP

They have to obtain a special DEA NUMBER, they may not treat more than 100 opioid dependent patients DEA STARTS WITH AN "X"

DISPENSER

a practitioner who so delivers a controlled substances to an ultimate user or research subject

Examples of Chemical Diversion and trafficking Act

acetone, benzyl chloride, ethyl ether, toluene, ephedrine

Manufacturing Labeling and Packaging

all commercial containers of a controlled substance must be labeled with identification sysmbols designating the schedule in which the drug has been placed ALL SCHEDULED DRUGS MUST BE ON ORIGINAL CONTAINER

DRUG ADDICITON TREATMENT ACT (DATA)

allowed only OTP'S to prescribed and dispensed for opioid addiction CSA TO ALLOW QUALIFIED PHYSICIANS TO PRESCRIBE AND DISPENSE schedule I,II,IV, and V opioids that have been approved by the FDA FOR MAINTENANCE OR DETOXIFICATION TREATMENT

Prescription of controlled substance may only be issued by?

an authorized prescriber in the state in which he or she is licensed to practice and is registered or exempt from registration under 21 CFR 1306.03

DEA FORM 224

any person wishing to register with the DEA as a dispenser

Records of Dispersal

any records that document the removal of drugs in the pharmacy

Anabolic Steroids Control Act of 1990

anyone who distributed or possessed with the intent to distribute, anabolic steroids other than for the treatment of a disease on the order of a prescriber is subject to 3 YEARS of imprisonment , a fine, or both, or 6 YEARS of imprisonment if the offense involved a minor under the age of 18 ANABOLIC STEROIDS SCHEDULE III legend drugs, athletes have obtained them easily

POWER OF ATTORNEY

authorizing designated persons to obtain and execute order forms if the person who recently signed the registration or reregistration is not around the power of attorney must be made for each individual for whom the pharmacy wants to have order authority, filled with executive order forms, and made available for inspection with the order form records

Inventory records

before a pharmacy begins business, an initial inventory must be conducted complete and accurate record of controlled substances the date the inventory is taken every 2 years (BIANNUAL INVENTORY) after the date on which the initial inventory was taken, the registrant must take a new inventory inventory may be taken at either the beginning or at the close of business exact count is needed for Schedule I and II exact count is needed for Schedule III, IV, V in packages of 1,000 or more if less than 1,000 you can GUESSTIMATE

METHADONE

can be dispensed by pharmacies for SEVERE PAIN but can't be prescribed or dispensed for the maintenance of detoxification of addicts in the regular course of business (has to be a detox clinic); CAN'T BE DISPENSE IN DECREASING AMOUNTS

Separate Registrations

chain pharmacy must have registration for each store not necessary for separate warehouses not necessary for one practitioner to maintain more than 1 registration when prescribing from more than one office, provided that the practitioner only prescribes controlled substances and dos not administer, dispense, or store them in more than one office ANYONE THAT CAN WRITE A PRESCRIPTION NEEDS A SEPARATE REGISTRATION

APPLICATION FOR REGISTRATION

current registrant will receive via mail the from from the DEA 60 days before the expiration date on the existing registration

The combat Meth Act of 2005 Public Law (April 8, 2006)

daily sales limit 3.6 grams of ephedrine, psudoephedrine and phenylpropanolamine; 9.0 gram limit of those in a 30 days period; for MAIL ORDER, confirm the identity of the purchaser prior to the shipping of product and limit of 7.5g in a 30 day period patients can still go to several different pharmacies and get the max. because there is no interaction between stores

SCHEDULE II

have a high potential for abuse have a currently accepted medical use in treatment in the US or a currently accepted medical use in severe restrictions abuse of the drug or other substance may lead to severe physical or psychological dependence

SCHEDULE I

have a high potential for abuse have no currently accepted medical use in treatment in the U.S lack accepted information on safety of their use, even under medical supervision researchers can purchase Schedule I

Issuance of Controlled Substance Prescription

information required dating issue correcting errors and omissions requirement of written prescriptions corresponding responsibility of pharmacist and prescriber

Consent requirement

inspector has to have a written consent signed by Pharmacists ( you withdraw consent if you are hiding something) Informed and understand the ff: right to refuse the inspection until an administrative inspection warrant has been obtained incriminating evidence found maybe seized and used against the owner or PIC in criminal prosecution notice of inspection have been presented consent may be withdrawn anytime during the course of inspection consent is voluntary and not coerced

PRACTITIONER

is a physician, dentist, veterinarian, scientific investigator, pharmacy, hospital, or other person licensed, registered or otherwise permitted by the US to DISTRIBUTE, DISPENSE, CONDUCT RESEARCH WITH respect to administer or use in teaching or chemical analysis

DEA ORDER FORM 222

it is unlawful for a person to distribute a controlled substance in schedule I or II to another EXCEPT PURSUANT TO A WRITTEN FORM ISSUED BY THE ATTORNEY GENERAL

DEA FORM 225

manufacturer, distributor, and narcotic treatment programs who wish to register with the DEA as dispenser

DEA Registration no.

must contain 9 digits two alphabet letter followed by 7 numbers assigned letter from DEA,the 2nd letter is the first letter of the registrant's last name,next 6 digits is computer generated, the lat digit is a computer calculated check digit DEA STARTED WITH B now F

DISPOSAL OR DESTRUCTION OF CONTROLLED SUBSTANCES WITHOUT DEA PRESENCE

pharmacy may prepare Form 41 listing all drugs to be destroys and a letter requesting permission to destroy the substances, proposing a date and method of destruction, and list the names of two people who will witness the destruction the pharmacy may at any time can forward the controlled substances to be destroyed to a DEA registered distributor the DEA will issue a blanket authorization for destruction on a very limited basis to registrants such as hospitals or clinics

The Combat Meth Act of 2005 Public Law 109-177

places EPHEDRINE, PSEUDOPHEDRINE AND PHENYLPROPANOLAMINE in the Scheduled Listed Chemical Products; may not sell such products in nonliquid form at retail unless the product is blister packs; 2 dosage unites in each blister; April 8, 2006; September 30, 2006 PROHIBITS LARGE AMOUNT OF METHS TO BE PURCHASED

SCHEDULE III

potential for abuse is less than SCHEDULE I, II currently accepted medical use in treatment in US moderate or low physical dependence or high psychological dependence

Issuance of Prescription CII

prescriber many not postdate or predate (has to be dated on the day the prescription CII is written) if address or DEA is not written the Pharmacist may enter those information in the prescription but by STATE LAW does not provide otherwise

Records of Dispersal Example

prescription record books DEA form 222 invoices, institutional records records of dispersal records of theft or loos

LOST OR STOLEN FORMS

purchaser must execute another 222 form with a statement noting that serial number of the lost form, date of lost form and the fact that substances ordered was not received copy 3 of the first and 2nd order form must be retained by the purchaser any used or unused forms stolen not under the course of transmission has to be reported to DEA; any entire book lost should be reported to DEA the date and approximate date of issuance; if found unused forms notify DEA mark "not accepted" by supplier o the 2nd order form if first order form was received

ORDERING DEA FORM 222

registrant must submit an order form request the requisition must be signed and dated either by the same person who signed the most recent application for registration or re-registration or by a person authorized to obtain and execute forms via POWER OF ATTORNEY REGISTRANT who needs more forms must specifically specify the number of request and show a reasonable need

DISTRIBUTION FROM A PHARMACY TO ANOTHER PHARMACY

sale or transfer of Schedule III, IV, V drug to another regsistrant and must be recorded by means of invoice that contains the ff: name of the substance dosage form strength number of dosage units number of commercial containers distributed date distributed name,address and registration number to whom the containers were distributed TRANSFERRER also fills DEA mails to DEA--> once the drugs are received, record a DEA 222--> MAX amount transfer can be made: 5% of what you have

What caused the DEA to come inspect

someone reported you if you order too much CII because it is a closed system so they know

Subutex

the beginning treatment and will likely administered by physicians from their offices directly to the patien buprenorphine sublingual tablets; PHARMACISTS should contact the physician for verification if they receive a prescription for Subutex

Practitioner can distribute by not being REGISTERED BY:

the practitioner to whom the drug is distributed is registered to dispense the distribution is recorded with the proper information by the distributing and receiving practitioners if the drugs is Schedule. I or II, Form 222 is executed the total number of dosage units distributed does not exceed 5% of the total units of controlled substances distributed and dispensed in 1 year

After filling an Emergency CII oral prescription

the quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period within seven days after authorizing the emergency oral prescription, the prescriber must deliver a written prescription to the pharmacy with a written not on its face "Authorization for emergency dispensing" Pharmacist attached the written prescription and the orally or electronic prescription with the written one If prescriber failed to do so within seven days, Pharmacist must notify the nearest office (DEA, Department of Justice,Commissioner of Public Health)

The Combath Meth Act of 2005 Public Law (Septembe 30, 2006)

the seller sells the products such that customers do NOT HAVE DIRECT ACCESS to the product before the sale is made; seller must maintain a WRITTEN ELECTRONIC LOG BOOK which must identify the product name, the quantity sold, name and address of purchasers, dates and time of sales; Purchaser must present an ID; the logbook to do not apply to sales that are 60mg or less of pseudophedrine; the seller maintains the logbook not fewer than TWO years after the date on which the entry was made; Penalties include seller and buyer, civil and criminal

DISTRIBUTING

to DELIVER a controlled substance WHOLESALERS need to register TO THE DEA deliverers do not need DEA licenses, they are blanketed under the distributo

Pharmacy Inspection

to determine whether pharmacies are complying with state and federal laws and regulation, ADMINISTRATIVE AGENCIES have the authority to inspect pharmacies constitutional requirement under the FOURTH AMENDMENT

DEA ORDER FORM 222 EXECUTION

use either a typewriter, pen or indelible pencil only schedule I and II drugs may be ordered on the form 10 number lines on each order form the NDC number is optional the wholesaler must enter the NDC number of the drug shipped the purchaser submits Copy 1 and of the order form to the supplier and retains Copy 3 for the purchaser's own files the supplier records on the first and second copies the number of containers furnished on each item and the date on which the containers were shipped to the purchaser

DISPOSAL OR DESTRUCTION OF CONTROLLED SUBSTANCES

Registrant should ask the DEA for the authority to do so as well as for instructions on the appropriate procedure they have to fill out the FORM 41 before you dispose your drugs at the end of the year or you can HIRE A REVERSE WHOLESELLER TO take back drugs--> must have DEA 222 form for CIIs--> after the destruction they have to submit DEA FORM 41

CONDUCTING RESEARCH

Researchers company needs to register with DEA but INDIVIDUAL researchers don't need to dispensers are allowed to conduct research with substances listed in Schedule I-V without registering separately as researchers condition for a dispenser to engage in research as a coincidental activity

Controlled Substance Registration Protection Act of 1984

Robberies, burglaries, and violent crimes are a constant threat to many pharmacists the Act mandates that a federal investigation occur if any of the following conditions are met: replacement cost of controlled substance taken is $500 or more, a registrant or other person is killed or suffer a significant injury, interstate or foreign commerce is involved in the planning or execution of the crime Fines imprisonment or both The logbook does not apply to 60 mg or less of pseudoephedrine

OPIOD TREATMENT PROGRAMS

SAMHASA (substance abuse and mental health services administration practitioner tend to treat opiod has to be registered OTP must be accredited by an accrediting body and recertified every 3 years Methadone and Levo-alpha-acethyl-methadol(LAAM) are the only two drugs authorized for use through an OTP

Why are drugs classified as controlled substances

Society has determined that certain drugs warrant stricter regulation and control than other drugs controlled substances or scheduled drugs have the potential for addiction and abuse

FDA approved medications for maintenance or detoxification

Subutex and Subonoxne

RECORD KEEPING

THE CSA requires that every registrant keep a complete and accurate record of all controlled substances. Controlled substance RECORD must be kept at least 2 years at the place of registration: " IN PRACTIVE IT IS WISE TO KEEP THE RECORDS LONGER THAN 2 YEARS BECASUE OF CONVERN OVER STATE STATUE OF LIMITATION AND OTHER STATE LAWS NEGLIGENT RECORD KEEPING can result to FINE AND IMPRISONMENT Records of CI and CII must be kept separate from CIII,CIV,CV

NON PRESCRIPTION SCHEDULE V SALES

THIS DEPENDS ON THE STATE CODEINE COUGH SYRUPS AND ANTIDIARRHEALS not legend drugs IN SOME STATES, THESE DRUGS MAY BE DISPENSED AND SOLD WITHOUT A PRESCRIPTION PROVIDED THAT: the dispensing is done only by a pharmacist quantity limits the purchaser is at least 18 years of age ID is provided bound records book allowed by law state