Basically, all steps before giving the product to the patient:

-Comparing Rx label to what is on script

- Selection of correct drug product from shelf

- Compounding, measuring, counting drug product

- Place in container and affixing lable

An article recognized in....

- US Pharmacopoeia

- Official Homeopathic Pharmacopoeia of the US

- Official National Formulary

Device/Drug that is available only by prescription and is required to bear either of the following labels

- RX only

- Caution: Federal law restricts this drug/device for use by or on the order of a licesed veterinarian

- 6 members

- 4 members are active pharmacists

- 2 of the active members must be retail pharmacists

- 1 of the active pharmacists must be in an institutional setting

- Members are nominated by the CT Pharmacist Association

- Vacancies are filled by the governor

- The commission meets six times a year in their offices

-  Records of disciplinary action are public, including the name/license # of any pharmacist being disciplined

- Can compel attendance of witnesses and production of documents

- Can administer oaths

- They can FORCE you to do this with the help of a judge

- The commissioner can adopt regulations that essentially allow him to do anything

- In terms of inspections, the commissioner may inspect facilities and take any steps he thinks are appropriate in correcting deficiencies.  

- He MUST inspect retail settings at least once every four years, and must have some method of sampling Rx's, based on the stores script performance

- Pretty much whenever the commission wants

- If you're in trouble in any state, even Puerto Rico, Washington DC, etc, in regards to drugs/devices/the practice of pharmacy/alcohol abuse, having private lines with physicians, too old to practice safely, diversion, illegal rebates, returned a drug to the pharmacy stock that was already dispensed in good faith, lying to the commission/falsifying information in any way, your license is THEIRS.  

$5,000 or 5 years in prison, or both, for EACH offense (each patient interaction/consultation that is illegal)

Note:  You can ALWAYS try and appeal this

If the person resides in CT --> The judicial district in which the person lives

If they do NOT live in CT --> Appeal to the Hartford-New Britain judicial district

If a non-legend drug permit is on the line --> Appeal to the judicial district where the building/store is

- Submission of an application for licensure in the state

- Satisfy all intern/experience hours

- Pay for, and pass the exam

- Be 18 years or older at time of exam

- The commission, with the approval of the commissioner, determines the contect/subject matter of each examination, and the place/time/etc.

-  It shall be given at LEAST 2x/year

- A temporary permit is for pharmacists that will be under direct supervision of another pharmacist, most likely when they're waiting to take their MJPE in the state.  They must already be in good standing and have a pharmacy license in another state

- The temporary permit is good for three months, or ends when they get their new state license.  

- Only ONE three month extension may be granted by the commission if they see fit.  

- Must pass a english proficiency test

- Must complete a graduate education equivalency exam, and the CT law exam

- License is good for one year

- Must submit application with fee (flashcard later) every year

- If a person FIRST applied for a CT license > 5 years ago, and hasn't renewed since, they may have to take another CT law exam before the renewal is granted

- In addition to the certificate of license, another document may be issued to display in the pharmacy

- Name/address of applicant and owner of pharmacy

- Name and address of pharmacy

- Name, address, license # of pharmacy manager

Note:  If the pharmacy moves locations, that pharmacy license is TERMINATED, and a new one must be submitted

- Names of officers/directors of the corporation

- Any change in officers/directors must be reported within 10 days of such a change or there will be a fee

- No practitioner, spouse of an MD (unless an Rph), or dependent child may own a pharmacy unless....

- They inherited it, owned it before 7/1/1993, or do not have professional liability insurance

Note: Failure to divulge any of the above to the comission , or if the practitioner reinstates such insurance and doesn't notify the Commissioner of Public Health within thirty days could result in a suspension of license.  

They MAY own pharmacy stock, as long as it is a publically traded company and they do not own more than one-half of one percent of all shares issued by the company.  Wow.

- No place of business may be operated as a pharmacy unless it has a pharmacy license and is under direct supervision of a pharmacist on the premises (unless the commissioner adopts a regulation specifying something different)

- Besides having a pharmacist on at all times, there must be a full-time PHARMACY MANAGER as well, listed on the store's license.  Pharmacy managers can only manage one pharmacy at a time

- The owner of a pharmacy, as well as the resigning pharmacy manager as well, must both notify the commission of a change in management within 10 days of such a change

- Must register at time of employment

- Must have completed at least two years of school, at an ACPE accredited institution, or has graduated from such a school

- If foreign, must take the english proficiency test, and a graduate equivalency exam

- If the intern drops out of school the registration card must be returned to the commission

- Must be under direct supervision of a pharmacist

- Direct supervision means the pharmacist is physically present in the area, and conducts in-process and final checks on the tech's performance

- Techs must be certified by the Pharmacy Technician Certification board or equivalent program

- Certifies the pharmacist completed the CE course

- Bears name of institution offering course, date completed, # of CE units, signature of institution director or agent

- a CE unit = 10 contact hours

- One contact hour = 50-60 minutes

- A retired Rph is 62 y/o or greater and is no longer actively practicing pharmacy, their license will say "inactive" on it and will be issued in the same manner as a regular license

- Each pharmacist needs 15 CE hours a year, 5 CE's should be live, 1 CE should be on Pharmacy/Drug Law

- A pharmacist applying for their FIRST renewal does NOT need to complete these CE's

- A pharmacist who has not renewed license in two years must sign a form saying they did their CE's

- CE Certificates must be kept for three years and be made available upon request.

- CE's cannot be carried over into following year

- If can't complete bc of illness, must submit a document for extension to the commission of pharmacy, if still can't complete CE's in allotted time, license could be revoked

- If "Retired," CE's are waived

- If coming OUT of retirement, pharmacist must complete 30 CE hours, 10 live, it doesn't say it but POSSIBLY 2 hours on Pharmacy/drug law

Name the following fees (this all may be bullshit)

- Issuance of Pharmacist License

- Pharmacy License Exam

- Issuance of a pharmacy license

- renewal of a pharmacy license

- renewal of a license to practice pharmacy

- notice of change in directors, and the late fee for failure to do this

- Pharmacists

- Techs

- Interns

- Pharmayc license for a business should be conspicuously displayed within the pharmacy

- If a business is NOT a pharmacy, it CANNOT use the following words on the outside of stue store or in any advertisement:  drug store, pharmacy, apothecary, drug, drugs, medicine shop, or any combination of words/symbols that hints at it.  

-Can be fined $100, imprisoned for 30 days, or both.  

- Pharmacists may advertise the price of any legend drug, as long as each advertisement clearly states teh period the price remains in effect, and shall NOT contain the statement that the price can change without notice.  

- Upon request, a pharmacist shall disclose the price of any such legend drug to any prospective purchaser

No legend drug/device, or specifically: Abx, biologicals, sulfonamides ingested for systemic effects, CCS, or opium tinctures may be sold at a retail level EXCEPT....

- In a pharmacy

- By a hospital if it is prescribed for an employee, their family, or to a hospital retiree as part of their pension plan.

If the pharmacist is not available, a nurse supervisor or physican may administer the drug, and record with the pharmacist later.  

Note:  Nothing is every stopping a physician from dispensing their own prescriptions to their own patients when authorized within the scope of his practice and done within the confines of the alw

- A proper physical examination by a physician.

- An electronic questionnaire filled out by a patient is not a valid evaluation in this case.  

- Pharmacist or pharmacy intern must, before the end of the day, record:

- Name/address of MD

- Date of Rx

- Name/Strength/Form/Qty of drug

- Name/address of patient

- If a vet, must have name of owner and species of animal

- Directions of use

- Cautionary statements

- Refills

- Written signature of physician

- Address of physician

- Date of issuance

- Name/form/strength/qty of drug

- Name/address of patient (owner/species if veterinary)

- Directions for use

- Cautionary statements

- Refills

Note:  If a CII, no other order can be written on the prescription

- Allows secure transmission between computer systems

- Intermediaries must apply to operate with the Commissioner of Consumer Protection, also needs approval of Commission of Pharmacy

- Each Rx is assigned a serial number

- Put all oral, written, eRx's in numerical order, keep for three years

- Records should at least have: Date filled, name/address of MD, name/address of patient or animal owner (species if animal), name of dispensing pharmacist

- Refills are recorded on face or back

- Records must be made available to authorized agent or commissioner or other person authorized by law.  

- If the pharmacy shuts down, records must be made available to nearby pharmacy, a notice must be kept in the window, applies to institutional pharmacies that dispense to outpatients

- When refills are available

- They are authorized by the MD

- If there are no refills LEFT and harm would come to the patient, therapy shouldn't be interrupted, etc., a 72 hour supply can be dispensed, but patient and practitioner must be made aware of  --> cannot do this more than once

The transferring pharmacist:  Must cancel original script (unless same chain with electronic system), write name of pharmacy transferring to and the date of transfer

Receiving Pharmacist:  Note that it is a transfer on the Rx, write the: name of transferring pharmacy and pharmacist, date of issuance and original Rx#, Date of first dispensing, refill record, refills authorized/remaining (basically everything in the life of the script?)

- Rph may sub therapeutically equivalent tablets, caapsules, liquids, but must inform patient and practioner

- They may only substitute if it saves the patient money

- Must have a sign posted saying that they can do this unless the patient disagrees

- Label will list the drug that they actually dispensed, and will have generic + mfg on label if there is no brand name available

- Rx must have "Brand Name Medically Necessary" listed on it if no generic wanted; if Medicaid, it seems as though a reason must be listed as well

- If "do not lable" is written, no drug name needs to appear on label

- The original medication order for the drug is discontinued

- The medication is in an unopened tamper-evident package

- The medication is not expired

- The original patient for whom it was intended is not charged (only the new patient is charged)

- Upon receipt of the medication by the facility from the licensed pharmacy, it is processed through the hospital's pharmacy or nursing home pharmacy

- When the needs of the patient dictate that the medication must be given immediately

- There is not a licensed pharmacy within 5 miles

- Up to a 24h supply of a non-controlled substance can be given pursuant to an authorization by a licensed practitioner that has examined the individual

- Anyone who applies to the commission for a permit may sell nonlegend drugs

- The permit is good for one year

- The holder of the permit must notify the commission of a change of ownership, name/location of the permit premises, this must be done within five days

- If you have this permit, you may sell nonlegend veterinary drugs as well

- The patient requests them

- The prescribing physician/a pharmacist treating the patient deems it medically necessary

- A person who is acting as a agent for a prescribing physician that is presently treating the patient

- Third party payors who pay claims for pharmacy services rendered to the patient

- Any government agency with statutory authority to review/obtain such information

- Any individual/state govt/fed. govt or court pursuant to a subpoena

- Any individual or corporation or legal entity which has a written agreement with a pharmacy to access the pharmacy's database provided the access is limited and cannot identify individuals

- A pharmacy that is located outside CT that ships,mails, or delivers, in any manner, legend drugs/devices pursuant to a prescription

-  They must register with the state and diclose annually all of their principal corporate officers, pharmacist, or report if any of these changes

- Submit a statement saying they comply with everything, have a valid inspection saying their facilities are up to snuff, have a toll-free number available at least 6 days a week during normal business hours to facilitate communication

- This license can be revoked if the nonresident pharmacy causes harm to a person of CT, and whatever agency within the other state doesn't...: initiate the investigation within 45 days, complete the investigation within 120 days, come to a decision/settlement within 180 days

A relationship in which.....

- The patient makes a medical complaint

- The patient provided a medical history

- The patient received a physical examination

- A logical connection existed between teh medical complaint, the history, the physical exam, and any drug prescribed

- Implement, modify, d/c drug therapy that has been prescribed

- Order associated laboratory tests and administer drugs

- If a drug therapy is discontinued, the pharmacist must alert the physician within 24h

- The specific drug(s) to be managed by the pharmacist

- The terms and conditions under which drug therapy may be implemented/modified/dc'd

- The conditions and events under which the pharmacist must notify a physician

- The lab tests that may be ordered

All activities by a pharmacist in conjunction with the protocol must be documented in the patient chart

- Regulatory action report that contains information regarding disciplinary action taken by them against anyone with a controlled substance registration

- Any sanction by the Commission of Pharmacy against a pharmacy or pharmacist.  

- Any person licnesed as a pharmacist may administer a vaccine to an adult for the following purposes:  Prevention of influenza, prevention of invasive pneuomococcal disease, prevention of herpes zoster and sequelae

- The pharmacist must have completed an immunization training program, and there must be some sort of system of control and reporting.  

- Do not administer a vaccine to anyone <18 years of age

- Sign must be in conspicuous location visible to consumers of prescription drugs.

- Should be at least 8x10 inches and lettering should be large enough so someone standing at the prescription department can easily read it.  

- Sign should say, "If you have a concern that an error may have occured in teh dispensing of your prescription you may contact the Department of Consumer Protection, Drug Control Division, by calling (blah blah blah number)

- On the receipt/bag in which the prescription is contained, it must say the same message.  It must be easily read.  

- 3 years

- Must be readily accessible within 48h if requested by the commission

- These records do not have to be disclosed for six months, unless requested earlier

- Licensed manufacturer/wholesaler/licensed pharmacy

- Physician or osteopath/dentist/vet/embalmer/podiatrist/scientific investigator

- Person in charge of a care-giving institution

- In charge of a licensed/registered laboratory

- To a farmer but only for use with his own animals or poultry

- A business authorized to purchase them for legit medical/industrial reasons

- Needle exchange program

- Without a prescription, no more than 10 at a time per customer

- With a prescription, really no limit, Rx is good for a year

- Can only be dispensed by a pharmacist, healthcare facility, or needle exchange program

- Same as controlled drugs for emergency stock (see below)

- Name of drug and strength

- Expiration date

- Lot number

- Mfg

- No one except a mfg or mfg representative with proper identification and documentation can sell a drug at a flea market

- No person may sell a food/drug/cosmetic at an auction unless a request at least seven days prior was sent to the commissioner, who may deem the legality of it.  This does NOT apply to food sold by churches, parent and teacher associations, or charitable organizations

- Can take a sample or specimen of any article

- Can enter any establishment within this state, at reasonable times, for the purpose of taking a sample/specimen

- Samples/specimens taken are submitted to the a gricultural experiment station or to the lab services section of the department of health

- It seems that when a sample is taken the commissioner, upon request, may provide a part for examination to the defendant or  their agent (to prevent abuse of power?)

- 

- Carriers engaged in intrastate commerce of food, drugs, devices, cosmetics, etc, shall permit inspectors to have access to and copy all records showing the movement of such goods

- It must show items, holding, movement, qty, shipper, etc

- 

- A drug distriution system used in hospital/chronic nursing home

- Drugs are supplied as individually labeled unit of use packages

- Each patient's supply is exchanged between the pharmacy and the drug administration area at least once every 24 hours.  

- Stored in patient-specific container

- Designate a substance as a controlled substance, with the exclusion of alcohol, nicotine, and caffeine

- Change the schedule of a particular substance (must submit a list of all schedule changes to chairmen and ranking members)

- If there is an inconsistency between CT schedules and federal schedules, the stricter of the two will prevail

- If the federal govt classifies a new substances as a control, and it is not controlled in CT, it will take effect in the state 240 days after.

- Need a license from teh commissioner of consumer protection

- Also need a license to operate a lab for the purpose of research/analysis on these substances

- Treating patients, such as what physicians and pharmacists do, does not apply to this act (unless it's narcs or CI-II)

- These licenses expire on 7/1 of each year, and for labs it is 2/1

- Substances must be kept at address that is on application

- Applicants must be of good moral character and must not have been convicted of a violation relating to a controlled substance in the past five years

- Another manufacturer or wholesaler

- Physican/dentist/vet

- Person in charge of hospital, learning institution, but only for use IN those institutions

- Person in charge of a lab

- Records must be kept for 3 years

- If it is for a CII, triplicate forms must be signed (222 form?)

- Name/address of patient, or owner/species if from a Vet

- Whether the patient is adult/child, OR the specific age

- Compound/preparation with qty

- Diretions for use

- Name/address of physician

- Date of issuance

- Federal Registry number of physician (DEA number?)

- If CII, only that one prescription on each pad

- Prescription must be in ink, indelible pencil, or typewriter, can NOT be a carbon copy, duplicate, printed/rubber stamped

- Must be signed at time of issuance

- If an emergency script, MD must mail real copy within 72 hours, and the two copies must be stapled together

- CII's in separate file

- CIII-V together, chronologically and consecutively

Extra:  Physician's may NOT prescribe anabolic steroids for muscle enhancement

- Person filling the script should include date of filling and his/her signature or initials, retain on file for three years

- Legal owner of a controlled substance stock, upon d/c of dealing in such substances, can sell this to a mfg, distributor, practitioner, wholesaler, or pharmacy, but for CII's you must use the 222 FORMS

- Upon written order, a pharmacist may sell to a registrant quantities of aqueous or oleaginous CII's which he has prepared as allowd in the Federal Controlled Substances Act

- A retail pharmacy or pharmacy within a hospital may, pursuant to the immediate needs of a patient, distribute a small amount of CIII-V to another pharmacy, but not more than 1 oz of powder/ointment, 16 oz of liquid, or 100 dosage units of tab/caps,supp/injectables

- Pharmacy may distribute CII-V as long as the practitioner has a federal and state registry number allowing him to purchase controlled substances

- He must be the director of such an institution

- Containers must have labels s tating drug, strength, exp date, lot, and mfg

- Limited in type/qty to those specificaly documented and uthorized for use as emergency stock

- Pharmacies distributing these must keep a written record of such transactions: name of receiving pharmacy, name/fed reg. number of medical director, date distributed, name/form/strength/qty of controlled substanc

- The receiving pharmacy/medical director must keep a written record as well

- Must have written order signed and initialed by physician

- If oral, must be confirmed by written order ^^ by such prescriber within 24h if a CII or 72h if another control

- Original/continuing orders for CII's are limited to 7 days, but may be extended by 7 more days by the signing/initialling of the order by a physician

- For other controls, continuing orders shall not be effective for more than 30 days

- Hospice goes by different ranges/protocols

- Pursuant to a prescription, and authorized by commissioner of consumer protection

- Must possess equal qty or less than the amount on the prescription

- Must be for  treatment of glaucoma or chemotherapy

- Date of receipt

- name/address of person from whom it was received

- kind/qty of CI received

- CI's administered, dispensed, disposed of

- Dates and names of person to whom the substance was administered/dispensed, with qty

- Date of receipt

- name/address of person from who sent the control to pharmacy

- qty/type of control received

- production/removal of controls (if mfg)

- dates sold, administered, dispensed

- Name/address to whom the control was dispensed, or owner of animal and species, substances sold, qty/type

- Hospitals and infirmary records show time of administering/dispensing, prescribing physician, nurse adminstering

- Keep separate from other records and maintain for three years

- All dispositions of controlled substances from any area of the hospital to other hospital locations

- Name/form/strength, qty of drug disepensed

- Date dispensed

- Location in hospital from which the drug was dispensed

- Records for specific patient: Full name of patient, complete description of each dose of medication with strength, form, qty, date/time administered and nurse involved and practitioner that prescribed

File in chronological order and maintained for three years

- Every two years

- Within four days of May 1st

- Registrant may change this date, provided it is within 6 months of May 1st

- Maintain for three years

- Made available for commissioner or authorized agents

- If any of the records needs to be seized, the agent shall provide the registrant with a receipt in lieu of the record, which also must be maintained for three years.  

- Electronic prescription drug monitoring program to collect prescription information for CII-V.

-The program should not infringe on the prescribing of such substances as long as the physician is acting in good faith and in the course of professional practice

- Report to the commissioner information for all controled substance prescriptions dispense

- Information: Dispenser ID number, date filled, Rx number, new Rx or refill, NDC of drug, Qty and days supply of drug, patient ID number, Patient's name/address, DOB of patient, date of prescription issuance, prescribers DEA number, type of payment

- May do electronically or format approved by commissioner

- Records may be requested by physicians and pharmacists as long as it is for therapeutic reasons, or to monitor controlled substance use

- Physician of internal medicine

- Board certified oncologist

- Person licesed to perform advanced level nursing practice activities

- Representative from acute care hospital 

- State police officer

- Municipal police chief

- Rep from Divisino of Criminal Justice

- Representative from hospice licensed by Department of Public Health 

- Pain management specialist

- Pharmacist

- Representative from Department of Mental Health and Addiction Services

What needs to be on the labeling of a controlled substance when....

- Sold/dispensed by a mfg

- Sold or dispensed by a pharmacist

- An aqueous or oleaginous preparation is sold

- MFG:  Name/address of vendor, qty/king/form of controlled substance, additional federal req's; only a practitioner may remove such a label

- Pharmacist: Name/address of pharmacy, name of patient (or name of owner if animal, and species), last name of prescriber, directions for use, serial number of Rx, date of filling/refilling, cautionary statements as required by law.

Federal:  - Name of patient

- Prescription number

- Date when prescription is written or dispensed

- Directions for use

- Name of prescriber

- Name/address of pharmacy

- Any cautionary statements

- Aqueous/Oleaginous preparation: Name, address, BNDD numbers of vendor and vendee, date of sale, kind/qty of substance, serial number of official written order.  

If you receive a prescription for a controlled substance, when can you move it from its original container?

Extra:  What is a common nuisance?

- I guess....never

- The person to whom the drug was supplied may lawfully possess it only in the container in which it was deliveredto him by the person selling/dispensing

Note:  A common nuisance is any dwelling,car, boat, etc. that is used to store or consume controlled substances by drug-dependent individuals

- Pretty much, you always have to let them in, as long as it is at a reasonable time (eg. not 4am)

- May inspect any place, clinic, infirmary, correctioan institution, care-giving institution, pharmacy, drug room, office, hospital, laboratory, factory, warehouse, establishment, or vehicle in which any controlled substance is held, mfg, compounded, processed, sold, delivered, or disposed of.  

- Can inspect the premises including any finished/unfinished material, containers and labeling, records, files, papers, processes, controls and facilies, inventory any stock/samples

- Can NOT inspect:  financial data, sales data other than shipment data, pricing data, personnel data, research data and secret processes/apparatus

- Also, cool little fact, they can arrest you on the spot

- May receive, take into custody, or destroy excess undesired controlled substances and may deliver, upon application to.....

- hospital

- Laboratory

- incorporated college/scientific instiution/state agency not operated for private gain any controlled substances that have come into his custody

- May recieve and take into custody excess controlled substances from pharmacists, mfg, and wholesalers or any other registrant

- Must keep full record of substances recieved, disposed of, kinds, qty, forms, persons received from, persons delivered to, who signed for the controls (upon seizure or delivery), dates or receipt, disposal, destruction

Within 72 hours to the commissioner of consumer protection

- If lost/destroyed in transit, must make a signed statement

- If substances were stolen, must immediately file with commissioner a signed statement that has list of substances stolen, and documentary evidence that the authorities were notified

- Two or more people (in long term care:nurse home admin, pharmacist, director of nursing services, assistant director of nursing services.  In outpatient surgical facility: admin, clinical director or chief of staff, nursing supervisor)

- Maintain records for three years

- May take into receive, take into custody, and destroy drug pariphenalia

- Keep full record of all drug para received and disposed of, must how: Drug, qty/form, person from whom received, by whose authority it was received and destroyed, dates of receipt or destruction

- Drug para held by law enforcement in evidence for criminal proceedings shall be destroyed upon order of the court by seizing authoroty or delivered to commissioner of consumer protection upon termination/resolution of case

- On conviction, a copy of hte judgement and sentence/opinion of the court is sent by the clerk/judge to the board by whome the person is registered.

- This notice may also recommend that the license be suspended or revoked.  

- A person may apply to have their license reinstated

- Federal, state, county/municipal officers (whose duty it is to enforce the lawas relating to controlled substances) and third party payors having a formal agreement to audit such records

- None of the above may divulge such information to anyone except in connection with a civil action/criminal prosecution in court or before a licensing registration board.

- Do not obtain a prescription in any sort of deceiving way, through lying, falsifying information, etc.

- Possess drug para with the intention of growing, mfg, using, etc., illicit substances

- Tell someone that a non-control is in fact an illicit substance, and sell it to them under that pretense

- Common sense is used in determining exactly what IS drug para, seriously

- 4oz Stokes expectorant, 4oz Brown mixture, 8oz of any preparation that has camphorated tincture of opium or opium equivalent not to exceed 16.2mg per oz, from which it cannot be easily extracted

- The mixture has to have a medicinal quality BESIDES the morphine substances, and must be administed in good faith, and the user must have a legit need for it

- Seller must have a CV record, contains : full name and address of person purchasing the preparation, signed by the purchaser, name and qty of preparation sold, date/time of sale.

- Must have drug label that has name/address of pharmacy, and no person may alter this label

- Only one such purchase in 48 hours

- Subpoena witnesses and papers

- administer oaths

- compel testimony of witnesses

- examine witnesses and may issue commissions to make testimony

- Chief toxicologist of the department of health services shall have the primary responsibility for analysis of materials

- Other toxicologists and professionals may be utilized if employed by the commissioner of health services or consumer protection

- Chief toxicologist establishes standards for analytical tests to be conducted

- Original test paper must be signed and dated by person actually conducting tests and specify: nature of tests/procedures, ID and number of samples, and results

- If being used, prosecutor must mail copy of test to defense, who must respond within 5 days if they're going to contest the introduction of the document, no trial may begin in this 5 day window

- Every practitioner who distributes, administers, or dispenses controlled substances or who proposes to engage in distributing, prescribing, administering or dispensing a controlled substance shall obtain a registration from the commissioner of consumer protection

- registration is good for two years

- Maintenance of effective controls against diversion

- Compliance with all state/federal laws regarding controlled substances

- Any conviction under state/federal law relating to controlled substances

- furnishing of false information by the applicant

- expiration/suspension/revocation of license

- dealing with controls in schedules outside of the practitioners authorization

- A pharmacy giving a non-controlled or controlled substance to another pharmacy, pursuant to a prescription, because they are out of stock and the patient needs it immediately

- A pharmacy giving drugs to another hospital or practitioner for research purposes

- A pharmacy giving drugs to a director of a long term care facility for emergency stock

- A pharmacy within a hospital, that contains ANOTHER hospital, gives drugs to that particular hospital (the latter), pursuant to an order by a physician, if giving care to an inpatient in one of their units

person whether within or without the boundaries of the

state of Connecticut who produces, prepares, cultivates, grows, propagates, compounds, converts

or processes, directly or indirectly, by extraction from substances of natural origin or by means

of chemical synthesis or by a combination of extraction and chemical synthesis, or who

packages, repackages, labels or relabels a container under such manufacturer’s own or any other

trademark or label any drug, device or cosmetic for the purpose of selling such items. The words

“drugs”, “devices” and “cosmetics” 

- Diabetes

- Asthma

- CHF

- HTN

- Hyperlipidemia

- Osteoporosis

- Smoking cessation

- There are pretty much equal requirements to secure a license in the previous state as well as CT

- graduated from an accredited school or to all equivalency exams if foreign

- Is a resident of the state of CT at time of applying or makes it clear that they will be practicing in CT (can't get a CT license just for the hell of it I guess)

- Has practiced pharmacy for at least one year within the past 5 years, or was licensed within the past 12 months, sometimes the commission may use their discretion

- the pharmacy board in the FIRST state grants similar reciprocal privledges

- The pharmacist passes the CT law exam and has a personal interview with the board of pharmacy

- date of commencement to the practice of pharmacy

- name of pharmacist's employer

- address of practice location

- type of practice

- name

- Home address

Note: must report within 5 days of commencement or change

- Must be open at least 35 hours a week

- If no pharmacy intern or tech is available to watch over the pharmacy, and the pharmacist is not in view, a locking mechanism should be used to keep unauthorized individuals out, or an alarm system that detects immediate entrance

- Commission does not HAVE to license entire premises as pharmacy, takes into account other products sold and % of floor space taken by pharmacy

- Pharmacy must be visibily separate from the rest of the store, must have barriers keeping people from illegally accessing prescription substances.  

- Hours must be conspicuously displayed, must be easily accessible to patients (the location, that is)

- Must be able to be opened by a pharmacist 24 hours a day

- Signs on the business can not imply that the entire store is a pharmacy

- business MAY have a door from the outside permitting the public direct access straight to the pharmacy portion

Extra:  Pharmacy must contact commissioner of consumer protection to decrease pharmacy hours, must do this 30 days prior (public must be notified as well).  If increasing hours again, must notify commission within 5 days of change

- Must be locked and protected by alarm

- Alarm can ONLY be shut off by pharmacist

- Deliveries to pharmacy must be kept secure until a pharmacist can supervise

- written prescriptions can be dropped in a one-way box

- no pick-ups can be made without the pharmacist's supervision

- Must receive approval from commission

- Only if a pharmacist can not reasonably work (in California when they have to work in CT the next day?)

- Must notify patients where they can pick up their prescriptions immediately

- Cannot close like this > once every year

- Cannot close > 18x a year or twice/month

- Must report such a closing within 72 hours

- 

If a pharmacy has received approval from the commission to operate when the prescription department is closed, they must....

- post, in block letters at least one-half inch in height, the hours of operation at all the entrances

- All advertising for the pharmacy must clearly state the hours of the prescription department

- If an advertisement refers to multiple listings, a statement that says "the services of a pharmacist may not be available at all times when the stores are open" can be used in lieu of specific hours for each store

- Square footage that will be licensed as the pharmacy premise

- The square footage of the entire premises of a pharmacy is contained within it

- Square footage of the prescription department (OK, I get it, the square footage of everything within the building)

- Square footage of storerooms/stockrooms

- Size of the prescription counter

- Location of the prescription department sink and refrigerator

- Location of the controlled drug safe

- Location of the toilet facilities

- Location and size of patient counseling facilities, if any

- 

- In a conspicuous manner within the prescription department, or within the immediate vicinity

- Must be displayed in an area that is clearly and readily identifiable to patients and customers

- If the pharmacy manager is absent for 16 or more days for any reason, the licensee should report him missing within five days of that sixteenth day, along with the name of the stand-in pharmacy manager

- at 42 day of absence, he/she is no longer the pharmacy manager, the owner of the pharmacy must submit to the commission the name/address/license number of the pharmacist who is assuming the responsibility

- The "absent" pharmacist must notify the commission of this as well

- Appear before the commission for a personal interview BEFORE their first day of work there

- In exigent circumstances, they may work first and then appear at the commission at the next meeting held

- The pharmacist must make sure the patient/patient's agent is aware of any drug substitution

- The patient may indicate that no substitution is to be made and that they want the drug that appears on the prescription

- on the written prescription, record the brand name; if no brand name, record the generic and mfg of the substituted product

- Same for oral scripts, except that he must initially write down both the brand and generic, or if no brand exists then generic and mfg.

- Record the retail price of the substituted product at time of dispensing

- name/strength/qty of medication?  

- If prospective purchaser cannot provide this information, the pharmacist may contact the prescriber for it

- In the case of product substitution, the pharmacist may also disclose the brand/generic/mfg of the product

Someone who is NOT compounding/engaged in activities related to the dispensing of drugs (counting, etc)

- Inputting and typing of insurance information and stocking shelves does NOT make someone a pharmacy tech in the eyes of the state

Outpatient - 1:2, 1:3 with permission

Inpatient - 1:3, 1:5 with permission

Satellite - 1:3, 1:5 with permission

Note:  If the techs fuck up in ANY way, it's YOUR license, so don't let Patty compound anything, seriously.

- Receive NEW prescriptions orally

- Consult with patient before or after dispensing or in regards to patients medical record

- Perform any identification/clarification on prescriptions

- Interpret medical data/perform consultations with medical personnel

- Make decisions regarding drug substititions

- Can contact prescriber for authorization for refills on NON-CONTROLLED substances, provided that...

- The pharmacist is aware this is happening, NOTHING has changed on the script, the pharmacist verifies nothing has changed, they wear identification indicating that they are indeed TECHS

- Ratio of 1:2, but could be 1:3, provided....

- doing intravenous admixtures and other steril product preparation, unit-dose packaging/bulk compounding

- If at least one of the techs is officially certified

- The supervising pharmacist has not provided notice that they don't want to supervise three techs, because they're like children

- Pharmacist has to write out a statement for the refusal, with the names/addresses of the pharmacies, the date and signature of the pharmacist, and must give it to the pharmacy manager

- must include, but not limited to, on-the-job and other education related to tech-work, should start before regular performance of these tasks

- Must register with department less than 35 days after start of such training

- Pharmacist manager in charge of in-service training for techs, must keep records indicating: name of individual, dates of training, general descriptions of topics, name of person supervising training, signature of tech and pharmacy manager.  If a new pharmacy mananger takes over, this person should review and sign the document, and keep it on record for inspection by the commissioner of consumer protection

- must contain name of pharmacy being transmitted to, and facility it is being transmitted FROM, if written for inpatient of chronic or convalescent nursing home, or some sort of rest home

- Must clearly state "prescription only valid if transmitted by means of facsimile machine"

- 

- may be faxed to a regular pharmacy provided that the original is brought to the pharmacist and reviewed prior to dispensing

- if for the purpose of direct administration (parenteral, IM, SQ), the fax will be regarded as the original

- If for long term care, CII may be faxed and accepted as the original

- Any system that keeps track of refill history must allow for ONLINE retrieval for a period of six months from the date of last dispensing via visual display or a hard copy printout of the original prescription information.

Must include:  Original Rx number, Date of issuance, Full name/address of patient, name/address of physician, name/strength,form,qty, substance prescribed vs. dispensed, total number of refills authorized

- must show, via online retrieval or hard copy printout all refills that are authorized for refilling

must include:  full name/address of patient, full name/address of prescriber, name/strength/form/qty of drug, date of refill, qty dispensed, date rx was first filled, original rx number, name/initials of dispensing pharmacist on each fill, total number of refills dispensed to date

- Must have daily printout of refills that is presented to the pharmacy within 72 hours of of refill dispense date

- Pharmacist must sign as a legal document to verify everything is correct within one shift of receiving the paperwork

- Must be maintained for a period of  three years

- if online retrieval is used, the most recent refills must be retrieval online for 6 months, the rest must be archived

- Must submit within 48 hours

Data must include.....

- Name of physician

- Name of patient

- name/dosage form/qty of drug

- date of dispensing for each refill

- name or initials of dispensing pharmacist

- number of the original prescription order

in the event a company does use an online system, there must be an auxillary system in place should the system go down

- 30 days prior to instituting an electronic system for refills retrieval, the pharmacy must notify the commission

- For safeguards:  guarantee the confidentiallity of data bank, after data has been entered by pharmacist ensure that no changes to data can take place

- System should be able to be reconstructed in the event of an accident

- Prior to dc'ing system, let the commission know 30 days prior, and provide up to date hard copy of past three years.

a pharmacy licensed under section 20-594 of the

Connecticut General Statutes wherein legend drugs and legend devices are stored and dispensed

and from which related pharmaceutical care services are provided, primarily to noninstitutionalized

patients living in a community setting

a pharmacy licensed under section 20-594 of the

Connecticut General Statutes wherein legend drugs, in the form of parenteral, enteral and

infusion therapies, and legend devices are stored, dispensed or sold and from which related

pharmaceutical care services are provided

a pharmacy licensed under section 20-594 of the Connecticut General Statutes wherein legend drugs, in the form of radiopharmaceuticals, and legend devices

are stored, prepared or dispensed and from which related radiopharmaceutical care services are

provided

a pharmacy licensed under section 20-594 of the

Connecticut General Statutes wherein specialized legend drugs and legend devices are stored and

dispensed and from which related pharmaceutical care services are provided including, but not

limited to, those relating to the treatment of diabetes, hemophilia and infertility

- The commission approves a pharmacy to practice in one or more classes

- Designates class based on the majority of business that the pharmacy has/will do

- No pharmacy may operate outside of its designated class

- If the pharmacy wishes to have its class reconsidered, it must notify the commission no later than 30 days after its  initial class designation is received

- Pharmacies may also request that their class be changed/modified

- Waivers for class designation may be granted if it will not compromise safety, the reason is clearly stated, compliance with the class designation will be burdensome.  The pharmacy manager must submit the request for the waiver, which will include:  specific regulation for which the waiver is requested, reason for the request, description of any alternative measures, any other relevant information included/requested --> the pharmacy manager will then be notified of the commission's decision

- License to operate nuclear pharmacy only given to someone who is, or employs, a nuclear pharmacist

- Nuclear Pharmacist must be present at all times, supervise the operation of only one pharmacy, be responsible for everything going on

- License to operate the pharmacy is contingent upon the proper state/federal documents to possess/distribute radioactive materials

- Nuclear pharmacies shall:  have adequate space and equipment to render services, be secured from entry by unauthorized persons, maintain records including the acquisition, inventory, and disposition of all radioactive materials

- Compound/dispense products that meet safety standards

- Dispense radiopharmaceuticals only after an order from a physician/physician agent, US Nuclear Regulatory Commission, or agreement state agency to possess such radiopharmaceuticals

- A nuclear pharmacist may xfer, to authorized persons and US Regulatory Commission licensed practitioners: radioactive materials NOT intended for drug use, and radiopharmaceuticals and other drug products for office use to these practitioners for individual patient use

- Nuclear Pharmacies may redistribute FDA approved radiopharmaceuticals if they do not process the drugs in any manner or violate product packaging, if this is the case then they also do not have to adhere to labeling requirements

- Name of institution and practitioner

- Requested date of dispensing and calibration time of radiopharmaceutical

- Name of procedure

- Name of radiopharmaceutical

- Dose or qty of radiopharmaceutical

- Rx # assigned to the order

- Any specific instructions

- Identity of person dispensing the prescription or medication order

-  Patient's name if for a therapeutic or blood-product radiopharmaceutical

- Name/address of pharmacy

- Name of prescribing practitioner

- date of dispensing

- Rx#

- If radioactive, must have radiation symbol and "Caution: Radioactive Material"

- Name of procedure

- Name or radionuclide and chemical form

- Amount of radioactivity and calibration time

- Expiration time

- Appropriate dosage units

- if solid, the number of items or weight

- if a gas, the number of ampules or vials

- The patient name if for individual therapeutic use, or the words "For physician use"

- Name of the radiopharmaceutical

- Serial number assigned to prescription or medication order of the radiopharmaceutical

- Standard radation symbol and words, "Caution: Radioactive Material"

- radiation detection/measuring equipment

- Radiation shielding

- Appropriate supplies and equipment for performing quality assurance testing

- a refrigerator

- materials for decontamination of radioactive spills

- supplies and equipment for compounding

- Access or a copy of United States Pharmacopoeia/National Formulary (USP/NF), or Remington: The

Science and Practice of Pharmacy; andthe current rules and regulations of the Nuclear Regulatory Commission or

agreement state.

- Name/address of applicant

- Business status of applicant (LLC, sole proprietorship)

- Description of system to be used that includes: security safeguards, retention and retrieval capabilities, safeguards to protect patient confidentiality

- Commission may require applicant to provide a protocol, and can approve applications as they see fit

- select and execute security measures

- establish physical safeguards to protect computer systems and other pertinent equipment from intrusion

- protect and control confidential patient information

- prevent unauthorized access to data when transmitted over communication networks or when data physically moves from one location to another using CD's, tapes, etc.

- Authenticate the sender's authority and credentials to transmit a prescription

- Encryption technology to maintain security

- controls on employee access

- protections against unauthorized access by outsiders

- procedures for the permanent deletion of patient information

- Each pharmacy must have quality assurance program to detect, identify, and prevent prescription errors, and must also document the errors as well

- If a pharmacist is made aware of a prescription error OTHER than by the patient or prescriber, he/she must notify both parties, as well as the potential negative impact on the patient, and the steps used to correct this error

- A quality assurance review must be done for EACH prescription

- Review must start as soon as possible, but no later than 2 business days after incident

- Quality assurance record must contain:  date of review and name/titles of people conducting it, pertinent data to the prescription error, documentation that patient and prescriber were contacted, findings and determinations, recommended changes to pharmacy policy/procedures

- Quality assurance records are kept for three years

- Each pharmacist should have access to the policy

- Pharmacy personnel must know to relay prescription errors to the pharmacist immediately

- Any changes to the policy must be relayed to the personnel

- Used needles should be placed intact directly into rigid puncture-resistant containers

- Needles should not otherwise be manipulated by hand

- Equipment that has safety measures for syringe handling built-in may be utilized per the manufacturer's standards

- Must have containers very close to area of use, and must be a one-way system

- Containers shall be kept secure at all times and possibly in a separate designated area prior to treatment

- These used needles are considered biomedical waste

- If treatment is not done on site, they should be transported in impervious containers

- All personnel should be well-trained in this crap

- Authorized by commissioner of consumer protection

Qualifiers:

- a need must exist for syringes

- no other device, tools, etc exist that could be used instead

- only sufficient qty for procedures

- safeguards and inventory control, limited stock access

- Full name, business address, and telephone number of registrant

- All trade or business names used by the registrant

- contact information for all people used by registrant for storing, handling, and distribution of prescription drugs

- Type of ownership or operation

- (5) The name(s) of the owner and/or operator of the registrant, including:

(A) If a person, the name of the person;

(B) If a partnership, the name of each partner, and the name of the partnership;

(C) If a corporation, the name and title of each corporate officer and director, the corporate

name, and the name of the State of incorporation; and

(D) If a sole proprietorship, the full name of the sole proprietor and the name of the business

entity;

(6) An indication as to whether the registrant will distribute controlled substances, legend drugs and/or over the counter drugs as well as a statement concerning the types of drugs to be distributed;

and

(7) A change in any information in this section shall be submitted to the Commissioner within 30 days of such change

- In summary, the business name and contact information, and the name of whoever owns it, and what substances they deal in

- It may operate under one registration

- However, if the wholesaler distributes controlled substances at these locations, each facility must be registered separately

What volatile substances are deemed controlled if the purpose of said chemical substances shall be breathed, inhaled, sniffed or drunk to

induce a stimulant, depressant or hallucinogenic effect upon the higher functions of the central

nervous system?

Acetone;

toluol;

trichloroethylene;

isopropanol;

methanol;

ether;

methyl cellosolve acetate;

toluene;

hexane;

butyl alcohol;

benzene;

methyl ethyl ketone;

cyclohexanone;

pentochlorophenol;

ethyl acetate;

methyl isobutyl ketone;

trichloroethane, and dichlorodifluoromethane.

(19) Lysergic acid diethylamide;

(20) Marihuana;

(21) Mescaline

Tetrahydrocannabinols except Dronabinol 

Gamma-hydroxy butyric acid

(3) Mecloqualone;

(4) Methaqualone; or

(5) Zolazepam

(1) Acetorphine;

(2) Acetyldihydrocodeine;

(3) Benzylmorphine;

(4) Codeine methylbromide;

(5) Codeine-N-oxide;

(6) Cyprenorphine;

(7) Desomorphine;

(8) Dihydromorphine;

(9) Drotebanol;

(10) Etorphine, except hydrochloride salts;

(11) Heroin;

(12) Hydromorphinol;

(13) Methyldesorphine;

(14) Methyldihydromorphine;

(15) Morphine methylbromide;

(16) Morphine methylsulfonate;

(17) Morphine-N-oxide;

(18) Myrophine;

(19) Nicocodeine;

(20) Nicomorphine;

(21) Normorphine;

(22) Pholcodine;

(23) Thebacon

Raw opium

opium extracts

opium fluid extracts

powdered opium,

granulated opium

tincture of opium

codeine

ethylmorphine

etorphine hydrochloride,

hydrocodone

hydromorhone

metopon

morphine

oxycodone

oxymorphone

thebaine

Dihydrocodeine;

(8) Diphenoxylate;

(9) Fentanyl;

(10) Isomethadone;

(11) Levo-alphacetylmethadol or LAAM;

(12) Levomethorphan;

(13) Levorphanol;

(14) Metazocine;

(15) Methadone

Phenazocine;

(23) Piminodine;

(24) Racemethorphan;

(25) Racemorphan;

(26) Remifentanil;

(27) Sufentanil

(1) Amobarbital;

(2) Glutethimide;

(3) Pentobarbital;

(4) Phencyclidine; and

(5) Secobarbital.

(e) Hallucinogenic Substances:

(1) Nabilone

(1) Benzphetamine;

(2) Chlorphentermine

(3) Clortermine;

(4) Phendimetrazine

- Any compound, mixture or preparation containing: Amobarbital, Secobarbital,

Pentobarbital or any salt thereof and one or more other active medicinal ingredients which are

not listed in any schedule

- Any suppository dosage form containing Amobarbital, Secobarbital, Pentobarbital or

any salt of any of these drugs and approved by the Food and Drug Administration for marketing

only as a suppository

- (A) Products containing a ratio of fifteen milligrams of long or intermediate acting

barbiturates combined with at least one of the following:

(i) 188 mg aspirin;

(ii) 375 mg salicylamide; or

(iii) 70 mg phenacetin, acetanilid or acetaminophen;

(B) Products containing a ratio of fifteen milligrams of short acting barbiturates

combined with at least one of the following:

(i) 307 mg aspirin;

(ii) 614 mg salicylamide; or

(iii) 106 mg phenacetin, acetanilid or acetaminophen;

(4) Any compound, mixture or preparation containing equal weights of both tiletamine

and zolazepam or any salt thereof and not mixed with other psychoactive substances;

(5) Chlorhexadol;

134

(6) Dronabinol (synthetic) in sesame oil and encapsulated in a soft gelatin capsule in a

United States Food and Drug Administration approved drug product;

(7) Ketamine or any salt thereof;

(8) Lysergic acid;

(9) Lysergic acid amide;

(10) Methyprylon;

(11) Sulfondiethylmethane;

(12) Sulfonethylmethane;

(13) Sulfonmethane.

(c) Buprenorphine.

(d) Nalorphine.

(1) Alprazolam;

(2) Barbital;

(3) Bromazepam

(4) Camazepam;

(5) Chloral betaine;

(6) Chloral hydrate;

(7) Chlordiazepoxide;

(8) Clobazam;

(9) Clonazepam;

(10) Clorazepate;

(11) Clotiazepam;

(12) Cloxazolam;

(13) Delorazepam;

(14) Diazepam;

(15) Dochloralphenazone;

(16) Estazolam;

(17) Etholorvynol

(18) Ethinamate;

(19) Ethyl-lofiazepate;

(20) Fludiazepam;

(21) Flunitrazepam;

(22) Flurazepam;

(23) Halazepam;

(24) Haloxazolam;

(25) Ketazolam;

(26) Loprazolam;

(27) Lorazepam;

(28) Lormetazepam;

(29) Mebutamate;

(30) Medazepam;

(31) Meprobamate;

(32) Methohexital;

(33) Methylphenobarbital (mephobarbital);

(34) Midazolam;

(35) Nimetazepam;

(36) Nitrazepam;

(37) Nordiazepam;

(38) Oxazepam;

(39) Oxazolam;

(40) Paraldehyde;

(41) Petrichloral;

(42) Phenobarbital;

(43) Pinazepam;

(44) Prazepam;

(45) Quazepam;

(46) Temazepam;

(47) Tetrazepam;

(48) Triazolam;

(49) Zaleplon;

(50) Zolpidem;

(51) Zopiclone

(a) Any compound, mixture, or preparation containing limited quantities of any of the

following controlled drugs, which also contain one or more noncontrolled active medicinal

ingredients in sufficient proportion to confer upon the compound, mixture, or preparation, valuable

medicinal qualities other than those possessed by the controlled drug alone:

(1) not more than 200 milligrams of codeine, or any of its salts, per 100 milliliters or per 100

grams;

(2) not more than 100 milligrams of dihydrocodeine, or any of its salts, per 100 milliliters

or per 100 grams;

(3) not more than 100 milligrams of ethylmorphine, or any of its salts, per 100

milliliters or per 100 grams;

(4) not more than 2.5 milligrams of diphenoxylate and not less than 25 micrograms of

atropine sulfate per dosage unit;

(5) not more than 100 milligrams of opium per 100 milliliters or per 100 grams;

(6) not more than 0.5 milligrams of difenoxin and not less than 25 micrograms of

atropine sulfate per dosage unit.

(b) Unless specifically excepted or unless listed in another schedule, any material,

compound, mixture, or preparation which contains any quantity of the following substances having a

stimulant effect on the central nervous system, including its salts, isomers, and salts of such isomers:

(1) Pyrovalerone

(1) Drug Enforcement Administration Pharmacy number;

(14) Patient last name;

(15) Patient first name;

(3) Sex code;

(2) Birth date;

(16) Patient street address;

(17) State;

(18) Payment code for either cash or third-party provider; and

(11) Date prescription written;

(4) Date prescription filled;

(5) Prescription number;

(6) New-refill code;

(19) Drug name.

(7) Quantity;

(8) Days supply;

(9) National Drug Code number;

(12) Number of refills authorized;

(13) Prescription origin code;

(10) Drug Enforcement Administration Prescriber identification number;

- A pharmacy that maintains prescription information electronically, and that dispenses

a schedule II, III, IV, or V controlled substance to a person who is not an inpatient of a hospital,

correctional institution or nursing facility

- May transmit electronically, over an internet connection (rate >2400 baud), magnetic tape or computer disc.  If submitted on paper, must submit...

(A) The 20thday of the month for all prescriptions dispensed on and between the 1st and the 15th

days of the month; and

(B) The 5th day of the following month for all prescriptions dispensed on and between

the 16th day and the last day of the month.

(2) If the reporting date falls on weekend or a holiday, a pharmacy shall transmit the

required information by the next state of Connecticut workday.

(f) A pharmacy shall transmit the information required pursuant to this section in such a

manner as to insure the confidentiality of the information in compliance with all federal and state

statutes and regulations, including the federal Health Insurance Portability and Accountability

Act of 1996

(a) Other regulatory, investigative or law enforcement agencies for disciplinary, civil, or criminal purposes;

(b) Practitioners, for the purpose of education in lieu of disciplinary, civil or criminal action;

(c) Practitioners and pharmacists, for the purposes of patient care, drug therapy management and monitoring of controlled substances obtained by the patient; and

(d) Public or private entities, for statistical, research, or educational purposes, provided that the privacy of patients and confidentiality of patient information is not compromised

#100 Tablets or Capsules--shall be 1 unit

One pint of a liquid--shall be 1 unit

1/8 ounce of a powder, crystal, flake, or granule shall be 1 unit

One multiple dose vial--shall be 1 unit

Ten suppositories--shall be 1 unit

Ten single dose Ampules, Tubexes, Dosettes, Hyporettes, or other single dose package forms for

injection whether powder or in solution shall be 1 unit

- Weight of 750 lbs or more, or securely attached to building structure so it cannot be moved

- Walls, floors, and ceilings constructed of at least 8 inches of reinforced concrete or other substantial masonry, reinforced vertically and horizontally with 1/2 inch steel rods tied 6 inches on center, or the structural equivalent to such reinforced walls, floors, and ceilings

- Door of vault must have multiple position combination lock or equivalent, a relocking device or equivalent, and steel plate with a thickness of at least one-half inch

- The vault, if operations require it to remain open for frequent access, must be equipped with a "day gate" which is self-closing and self-locking or the equivalent. If the operation requires only that the vault be opened infrequently, such as to remove raw material in the

morning and return raw material at night, and is always relocked immediately after use, a "day gate" is not required

- (4) The walls, floor, and ceiling of the vault must be equipped with an alarm which, when unauthorized entry is attempted, transmits a signal directly to a central station protection company, or a local or state police agency which has a legal responsibility to respond, or a 24-hour control station operated by the registrant. If necessary, due to local conditions or other problems, holdup buttons shall be placed at strategic points of entry to the perimeter area of the vault.

(5) The vault door must be equipped with a contact switch.

(6) The vault must have at least one of the following:

a. Complete electrical lacing of the walls, floor and ceiling or

b. Sensitive ultrasonic equipment within the vault or

c. A sensitive sound accumulator system or

d. Such other device designed to detect illegal entry as may be approved by the Commissioner of

Consumer Protection.

(7) The electrical alarm system must be certified as being an Underwriters Laboratories,

Inc., approved system and installation

 Any loss, theft, or unauthorized destruction of any controlled substance(s) must be reported by a registrant within 72 hours of discovery of any such occurrence to the Commissioner of Consumer Protection as follows:

- Where through breakage of the container or other accident, otherwise than in transit, controlled substance(s) are lost or destroyed, the registrant shall make a signed statement as to the kinds and quantities of controlled substance(s) lost or destroyed and the circumstances involved. Forward to the commissioner, and the registrant retains a copy.

-  Where controlled substance(s) are lost by theft or otherwise lost or destroyed in transit, the consignee, and the consignor if within this state, shall forward to the Commissioner of Consumer Protection a signed statement which details the facts, includes an accurate listing of the controlled substance(s) stolen, lost, or destroyed and specifies that the local authorities were notified. A copy of the statement shall be retained by the registrant

- If CII < 250 units, store in a safe, if > 250 units, store in vault

- Schedule III, IV, V Stock shall be stored in an approved vault, approved safe equipped with a separate effective electrical alarm system, or separate secure locked caged area, room, or enclosure equipped with a separate effective electrical alarm system. If a caged area or enclosure is used, such caged area or enclosure must be completely enclosed. If a caged area is used,

construction must be of heavy gauge wire mesh having openings smaller than the smallest controlled substance(s) containers stocked

- In all processes, mfg must do best to avoid any kind of diversion

- If CII < 150 units, can use locked wooden or metal safe, if >150 units must use approved safe

- CIII-V can be kept in approved safe or dispersed throughout pharmacy, assuming theft/diversion has not occurred

- Schedule II and III Controlled Substance Stock, if total is < 15 units should be stored in a locked substantially constructed steel or wood cabinet in a securely

safeguarded location. if > 15 units store in an approved safe.

- In the case of veterinary practitioners an additional No. 25 controlled substance units of schedule II or III

controlled substance stock of the barbiturate type, for use solely for animal anesthesia or animal

euthenasia, may be stored in a locked substantially constructed steel or wood cabinet.

- Schedule IV and V Controlled Substance Stock shall be stored in a locked substantially constructed steel or wood cabinet or in a securely safeguarded location.

- In no case shall a practitioner's controlled substance stock be left unsecured or unattended in an examining room, treatment room, automobile, or in any other location accessible

to nonauthorized persons

- Schedule I and II Controlled Substance Stock shall be stored in an approved safe, EXCEPT where schedule II stock of the barbiturate type is used solely for its sedative or anesthetic effect on animals and < 10 units are stocked, in which cases security as outlined for schedule III controlled substances will apply.

- In instances in laboratories where schedule I or II stock may be unstable, of extremely small quantity, or of such a nature as to require special storage conditions, the Commissioner of Consumer Protection may approve of other security safeguards on an individual basis

- Schedule III, IV or V Controlled Substances Stock shall be stored separately from other drugs and substances in an approved safe or separate secure locked location accessible only to the minimum number of specifically authorized personnel essential for efficient operation.

- Controlled Substances in the process of testing, use, or research shall be immediately returned to the required storage location upon completion of each such process

- Schedule II and III Controlled Substance Stock in quantities of <150 units shall be stored separately from other drugs and substances in a separate secure substantially constructed locked metal or wood cabinet

- In hospital Labs, CII stock should be stored in an approved safe

- Schedule II and III controlled substance stock in quantities of No. 150 controlled substance units or more

but less than No. 1000 controlled substance units shall be stored in an approved safe

- Schedule II and III controlled substance stock in quantities of No. 1000 controlled substance units or more shall be stored in a completely enclosed masonry room or equivalent equipped with a vault-type steel door with horizontal or vertical locking bolts, having a three-tumbler combination lock and a relocking device. The completely enclosed masonry room or equivalent, if operations require it to be opened for frequent access, must be equipped with a "day gate" which is self-closing and selflocking or the vault type steel door must be equipped with a key locking device or an equivalent day locking device --> must also have electrical alarm which, upon an attempted unauthorized entry, transmits to a security entity which will be able to respond 24h a day

- Schedule IV and V Controlled Substance stock shall be stored in a secure location within the pharmacy prescription compounding area or drug room. Schedule IV and V Controlled Substance Stock stored within hospital clinical laboratories shall be kept in a separate secure locked location

- Schedule II Controlled Substances in small amounts not exceeding the quantity necessary for efficient operation kept at any specific individual area or location shall be stored in a locked substantially constructed nonportable and immobile metal cabinet or metal container within another separate locked enclosure.

- Keys shall not be the same for each of these locks and such keys shall be kept on two separated key rings or holders. Not more than one set of keys for the schedule II controlled substance cabinets shall be available to nonsupervisory personnel

- At the beginning of each work period or shift, a nurse must be assigned responsibility for the security of schedule II controlled substance stock. Such responsibility shall be assumed by each said nurse who shall prepare a signed inventory indicating each kind and quantity of schedule II (and III-V) controlled substance received, the time and date received, and from whom received.

This responsibility shall not be transferred or assigned to another nurse or person during the course of each work period or shift unless another signed inventory transferring responsibility is first prepared. 

- Schedule III, IV, V Controlled Substance Stock in small quantities intended foremergency use only, may be stored within an emergency drug kit or on emergency crash carts equipped with disposable locking or sealing devices, provided adequate security measures for such

controlled substance stock are maintained and required record-keeping procedures are complied with

- Shall be of substantial construction with a separate, lockable, non-removable drawer for  CII's

- The key to such drawer should be cart-specific, and can not work on any other locking device

- Locking mechanisms should not require the key 

- Mobile carts, whent NOT in use, must be kept in a secure location

- No duplicate keys shall be used, and only the nurse responsible for the controlled substance inventory for that shift may carry the keys

- Controlled substance inventory is done at time of administration

- Director of nursing should do random audits at least twice a month for the controlled substance inventory

- With CII and CIII, <15 units or less shall be stored separate from other drugs and substances in a separate secure substantially constructed locked metal or wood cabinet, if >15 units, shall be stored in an approved safe

- Schedule IV and V Controlled Substance Stock shall be stored in a separate secure locked location or with Schedule II and III Controlled Substances in compliance with security measures as required per section 21a-262a

- Controlled Substances for Stock use shall be purchased or obtained by the medical director or physician in charge from a wholesaler or manufacturer of drugs, and shall be handled only by an authorized physician, Connecticut licensed pharmacist, or Connecticut licensed nurse.

- Controlled substances shall be the property of the medical director or physician in charge who shall be responsible for security requirements and record keeping procedures.

- The same security requirements shall apply for controlled substances obtained pursuant to patient(s) prescriptions as for stock controlled substances. Controlled substances obtained pursuant

to such individual patient(s) prescriptions shall not be used for any other patient(s) and when no

longer required for the intended specific individual patient shall be securely kept and

safeguarded until properly disposed of

- Supervising physician is satisfied with competency/ability of PA

- Within scope of practice

- May prescribe/administer/renew all scripts in II-V category, if within scope of practice

- All prescription forms used by physician assistants shall contain the printed name, license number, address and telephone number of the physician under whose supervision the physician assistant is prescribing, in addition to the signature, name, address and license number of the physician assistant

- No physician's assistant may independently engage in practice of medicine

- PA MAY determine someone to be dead, as long as they sign the certificiate of death no more than 24h later, or a physician signs it

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CII - 90 Days

CIII-V - 90 days or more apparently