pharmacy law
How long are "99" fills are valid for?
"99" fills are valid for 2 years from the date of issuance. (frequently used to indicate refills for oxygen prescriptions)
How long are "PRN" refills are valid for?
"PRN" refills are valid for 1 year from the date of issuance.
Prior to the passage of the Secure and Responsible Drug Disposal Act of 2010 consumers lawfully possessing unused or expired pharmaceutical controlled substances had three options for proper disposal:
(1) dispose by flushing or trashing pursuant to Drug Enforcement Administration ("DEA") guidelines (2) turn the substances over to law enforcement (3) seek assistance from DEA
can issue unlimited prescriptions at one time for the same drug as long as it does not exceed a (90) days supply. give examples
(3) prescriptions for Oxycontin, cannot post-date or pre-date prescriptions. Must have the current date, the other two will have notes for 'do not fill' dates until 30 day period has passed; must have directions on all the prescriptions
how to calculate a DEA #
9 digit number: consists of letters and numbers the first letter indicate full prescriptive authority. A,B OR F-FULL LEVEL M-MID LEVEL Second letter is the first letter of their last name: Holland="H" add 1st+3rd+5th numbers=A add (2nd+4th+6th)X2=B then add "A" + "B"=CD and the "D" number should correspond to the last number of DEA #.
How many times a 30 day supply with 11 refills can be dispensed?
A 30 day supply with 11 refills indicates that a 30 day supply shall not be dispensed more than 12 times within 1 year from the date of issuance.
How many times a 30 day supply with 12 refills can be dispensed?
A 30 day supply with 12 refills indicates that a 30 day supply shall not be dispensed more than 13 times within 2 years from the date of issuance.
Is developed by the drug's sponsor to support implementation of an element of the REMS, and can inform key audiences (health care providers) about the risks of the drug.
A communication plan
May a physician assistant prescribe CII drugs in Virginia?
A licensed physician assistant shall have the authority to prescribe controlled substances and devices.
Are prescription "drop boxes" permitted?
A pharmacy may utilize a drop box for the collection of written prescriptions and refill requests. The drop box must be located in a visible area within the permitted facility and must be locked at all times with access to the items placed in the drop box restricted to pharmacists practicing at the pharmacy or an authorized pharmacy technician practicing at the pharmacy when a pharmacist is on duty. The drop box shall be constructed in a manner to prevent the theft or loss of a written prescription or confidential information and shall be bolted to the floor or a fixed structure. At no time shall a patient be allowed to leave containers to be refilled which contain drug.
Exceptions to the disposal of controlled substances by individuals who are not 'ultimate users'
A. If someone dies while in lawful possession of pharmaceutical controlled substances, any person lawfully entitled to dispose of the decedent's property may dispose of the pharmaceutical controlled substances B. A long-term-care facility may dispose of a current or former resident's pharmaceutical controlled substances.
May patient's fax you his/her prescription for filling?
A. Unless otherwise prohibited by federal law, prescription orders for Schedule III through VI drugs may be transmitted to pharmacies by facsimile device (FAX) upon the following conditions: 1. The prescription shall be faxed only to the pharmacy of the patient's choice. 2. A valid faxed prescription shall contain all required information for a prescription. A written prescription shall include the prescriber's signature.
If a prescription is dispensed in multiple containers, for example at a parent's request to have an extra container to send to school, how must the prescription be labeled? May only the school instructions be placed on the school container?
All containers should be labeled with the same instructions and must reflect the prescriber's complete instructions.
Schedule IV Controlled Substances Substances in this schedule have a low potential for abuse relative to substances in schedule III. NAME SOME EXAMPLES:
An example of a schedule IV narcotic is propoxyphene (Darvon® and Darvocet-N 100®). Other schedule IV substances include: alprazolam (Xanax®), clonazepam (Klonopin®), clorazepate (Tranxene®), diazepam (Valium®), lorazepam (Ativan®), midazolam (Versed®), temazepam (Restoril®), and triazolam (Halcion®).
Pharmacist refuses to fill a prescription. What must be done, if anything, in VA?
If a pharmacist declines to fills a rx for any reason other than the unavailability of the drug prescribed, he shall record on the back of the rx the word "declined"; the name, address, and telephone number of the pharmacy; the date filling of the rx was declined; and the signature of the pharmacist If forgery; the pharmacist shall not return the forged rx to the person presenting it. It may be given to a law-enforcement official investigating the forgery; or it shall be retained for a minimum of 30 days before destroying it, in the event it is needed for an investigative or other legitimate purpose.
In VA, Prescription blanks:
If a pharmacy provides prescription blanks to prescribers, no advertising or other information shall be on the face of the prescription blank other than prompts for essential information required by law to be on a written prescription. Any nonessential information such as coupons or pharmacy name may be placed on the back of the prescription blank or on a separate sheet of paper, but shall not be on or attached to the face of the blank.
The drug's sponsor may be required to take reasonable steps to monitor and evaluate those in the healthcare system who are responsible for implementing ETASU measures, if certain ETASU are required.
Implementation system
Does the phrase "within the course of professional practice" limit a physician's authority to prescribe to that physician's practice area?
It does not. Technically any physician can prescribe for any drug they feel comfortable due to the fact that he/she has full prescriptive authority.
What are the requirements for a valid prescription in Virginia?
Patient: First and last name, and Address Prescriber: Name, Address, Telephone #, DEA # if for a Schedule II-IV Interns and residents may use hospital DEA # Physician assistants shall include name of supervising physician Qty is not required, but direction is needed Written prescription shall be dated with the date the prescription is written
Located in MD, dispensing/mailing drugs to states outside of MD?
Register as non-resident pharmacist in those other states
What does Virginia say about storage of CII drugs?
Same as Federal; basically anywhere
WHAT IS A Scheduled Listed Chemical Product (SLCP)?
Scheduled Listed Chemical Product (SLCP) An SLCP is defined as a product that contains ephedrine, pseudoephedrine, or phenylpropanolamine and may be marketed or distributed lawfully in the United States under the Federal Food, Drug, and Cosmetic Act as a nonprescription drug.
TRUE OR FALSE. Residents, Interns, Physicians etc. can work under the hospital's DEA number
TRUE
TRUE OR FALSE. You have to conduct an initial inventory prior to opening a new pharmacy. (all controlled substances on hand) subsequent inventories will be conducted every two years thereafter.
TRUE
TRUE or FALSE. All SLCPs must be stored behind the counter or, if in an area where the public has access, in a locked cabinet.
TRUE
You can be denied/suspend/revoke DEA registration if you:
convicted of a felony related to controlled substances, etc.
Renewal of registration for controlled substances, you must you what form? and how often?
every (3) years with form 224a
The CSA is a closed system of distribution meaning every step that the drug goes through is accounted. What is the purpose?
To try to prevent diversion
True of False. Controlled substances that are collected from ultimate users shall not be co-mingled with a registrant's inventory/stock of controlled substances (i.e., registrants shall not dispose of controlled substance inventory in a collection receptacle or mail-back package, or through a take-back event).
True
Newly Scheduled Controlled Substance Inventory
When a drug not previously listed as a controlled substance is scheduled or a drug is rescheduled, the drug must be inventoried as of the effective date of scheduling or change in scheduling.
May a pharmacist distribute prescription drugs, including controlled substances, to a physician if the physician writes a prescription "for office use."?
1. A permitted pharmacy may engage in wholesale distributions of small quantities of prescription drugs without being licensed as a wholesale distributor when such wholesale distributions are in compliance with federal law as follows: such wholesale distributions of controlled substances do not exceed 5% of the gross annual sales of prescription drugs by the relevant permitted pharmacy or such wholesale distributions of Schedules II through V controlled substances do not exceed 5% of the total dosage units of the Schedule II through V controlled substances dispensed annually by the pharmacy. 2. If the requested drug is classified as Schedule II, the physician wishing to obtain the drug must execute a Drug Enforcement Administration (DEA) Form 222 as the "purchaser" and provide this form to the transferring pharmacy. The transferring pharmacy would then complete DEA Form 222 acting as the "supplier" in this instance. Copies of DEA Form 222 must then be properly forwarded as required by federal law
The mission of FDA's Center for Drug Evaluation and Research (CDER) is to ensure that drugs marketed in this country are:
1. Safe and Effective. CDER does not test drugs, although the Center's Office of Testing and Research does conduct limited research in the areas of drug quality, safety, and effectiveness It has responsibility for both prescription and nonprescription or over-the-counter (OTC) drugs
A chart order may be filled by an outpatient (community/retail) pharmacy for outpatient use provided the following conditions are met:
1. The chart order was written for a patient while in a hospital or long-term care facility. 2. The pharmacist has all information necessary to constitute a valid outpatient prescription. 3. The pharmacist in an outpatient setting has direction, either written or obtained verbally, that the chart order is actually intended to be outpatient or discharge prescription orders, and not merely a listing of drugs the patient was taking while an inpatient. 4. The orders include some direction related to quantity to be dispensed or authorized duration of the order by which the pharmacist can calculate the authorized quantity using directions for use and duration
Collectionf rom Ultimate Users Authorized collectors may collect pharmaceutical controlled substances from ultimate users using one of the following methods:
1. collection receptacles 2. mail-back programs
The following categories of registrants may modify their registration to become collectors if they are authorized to handle schedule II controlled substances: Becoming a collector is voluntary
1. manufacturers 2. distributors 3. reverse distributors 4. narcotic treatment programs 5. hospitals/clinics with an on-site pharmacy 6. retail pharmacies. Law enforcement continues to have autonomy with respect to how they collect pharmaceutical controlled substances from ultimate users, including maintaining collection receptacles, and conducting mail-back programs and take-back events
Emergency situations requirements:
1. quantity prescribed and dispensed must be limited to the emergency situation. 2. Must immediately reduce it to writing 3. your written must contain all of the required fields the regular controlled substances have, minus the signature 4. reasonable means to verify the doctor's orders 5. The prescriber must(mail) provide the pharmacist with an actual prescription within (7) days of the 'phone in'. 5. must include the date of the 'phone in' and the emergency purpose on the new script from the MD
How do you transfer scheduled drugs ?
1.)To transfer schedule II substances, the receiving registrant must issue an official order form (DEA Form 222) or an electronic equivalent to the registrant transferring the drugs. 2.)The transfer of schedules III-V controlled substances must be documented in writing to show the drug name, dosage form, strength, quantity, and date transferred. The document must include the names, addresses, and DEA registration numbers of the parties involved in the transfer of the controlled substances.
Schedule I Controlled Substances Substances in this schedule have a high potential for abuse, have no currently accepted medical use in treatment in the United States, and there is a lack of accepted safety for use of the drug or other substance under medical supervision. NAME SOME EXAMPLES:
1.heroin 2. lysergic acid diethylamide (LSD) 3.marijuana (cannabis) 4.peyote 5. methaqualone 6.3,4-methylenedioxymethamphetamine ("ecstasy").
One important new requirement is that those entities who reverse distribute must destroy controlled substances received for the purpose of destruction within how many days of receipt? [Day 1 is the day the substances are physically acquired through pick-up or delivery.]
30 calendar days of receipt
May you continue to dispense a prescription when? the prescribing physician retires? when the physician relocates to a different state? When the physician dies? When the physician's license is suspended/revoked? Answer: Yes in all of the above cases because physician death, retirement or loss of license does not void prescription written prior to the date the physician ceased practicing. So, the pharmacist can fill the prescription and any authorized refills as long as the pharmacist use his professional judgment and the prescription was written for a legitimate medical purpose and pursuant to a valid physician-patient relationship. Reference: Virginia Board of Pharmacy
Answer: Yes in all of the above cases because physician death, retirement or loss of license does not void prescription written prior to the date the physician ceased practicing. So, the pharmacist can fill the prescription and any authorized refills as long as the pharmacist use his professional judgment and the prescription was written for a legitimate medical purpose and pursuant to a valid physician-patient relationship. Reference: Virginia Board of Pharmacy
Who can operate a mail-back program for the collection of pharmaceutical controlled substances?
Authorized collectors with an on-site method of destruction may operate a mail-back program.
Transfer regarding scheduled drugs:
CAN ONLY TRANSFER THE CONTROLLED SUBSTANCE Rx ONCE WITH TWO DIFFERENT COMPANIES BUT THE SAME COMPANY MORE THAN ONCE. CII: MUST USE DEA FORM 222; CIII-CV: The transfer of schedules III-V controlled substances must be documented in writing to show the drug name, dosage form, strength, quantity, and date transferred. The document must include the names, addresses, and DEA registration numbers of the parties involved in the transfer of the controlled substances.
Recording keeping regarding scheduled drugs:
CII: 2 years CIII-CV: 2 years
Phoned In regarding scheduled drugs:
CII: No bc you must have a hard copy(written, NO fax). [exceptions are I. emergency situations; II. faxed can be accepted provided the pt population is appropriate (home infusion, residents of LTC or hospice pts); III. If the drug is being partially filled] CIII-CV: yes, must immediately transcribe the prescription
Time restrictions to fill regarding scheduled drugs:
CII: No time restriction (excluding. quantity restriction of 90) CIII-CV: Yes; (6) months
Partial refills regarding scheduled drugs:
CII: Yes but certain requirements must be met(I. unable to supply the entire quantity (out of stock, pt cannot afford,or need to verify the legitimacy of the prescription) must complete the partial fill within 72 hours. If you cannot then the pt cannot get the remainder of the quantity. CIII-CV: Yes but unlimited provided that the total quantity dispensed does not exceed the total quantity prescribed.
Refills regarding scheduled drugs:
CII: Zero; prohibited CIII-V: (5) times within six months; refer to state law for CV drugs can be different
Inventory filing records regarding scheduled drugs(ex. DEA form 222 or the electronic order form used to purchase :
CII: must be separate CIII-V: a.) separate from all other records or b.) contained with other records as long as they are readily retrievable
Prescription filing regarding scheduled drugs:
CII: must be separate CIII-V: a.) separate from all other records or b.) contained with other records as long as they are readily retrievable
Security requirements regarding scheduled drugs:
CII: safe or dispersed in the open(but to prevent diversion) CIII-CV: dispersed on the general safe or locked in a safe
If I become an authorized collector and decide to stop, how do I do so?
Collection receptacle: Authorized collectors maintaining a collection receptacle must dispose of all collected pharmaceutical controlled substances in their possession in accordance with the new rule, and notify the DEA that collection activities are ceasing, in writing or online at http://www.DEAdiversion.usdoj.gov. Mail-back program: Authorized collectors operating a mail-back program must make a reasonable effort to notify the public prior to discontinuing or ceasing collection; obtain the written agreement of another collector to receive all remaining mail-back packages; and notify the DEA that collection activities are ceasing, in writing or online at http://www.DEAdiversion.usdoj.gov
This form must be used to record the destruction of all controlled substance inventory, as well as the destruction of pharmaceutical controlled substances that are collected from ultimate users.
DEA Form 41
Secure and Responsible Drug Disposal Act of 2010
Disposal Act (The Disposal Act amended the Controlled Substances Act (CSA) to give the DEA authority to promulgate new regulations, within the framework of the CSA, that will allow ultimate users to deliver unused pharmaceutical controlled substances to appropriate entities for disposal in a safe and effective manner consistent with effective controls against diversion. The goal of the Disposal Act is to encourage public and private entities to develop a variety of methods of collection and disposal in a secure, convenient, and responsible manner.)
Are there environmental impacts?
Disposed pharmaceuticals must be rendered non-retrievable in compliance with all applicable Federal, State, tribal, and local laws, including those relating to environmental protection. By expanding options on how ultimate users may dispose of their pharmaceutical controlled substances, fewer of these substances may end up in our nation's water system.
Are required medical interventions or other actions healthcare professionals need to execute prior to prescribing or dispensing the drug to the patient. Some actions may also be required in order for the patient to continue on treatment.
Elements to Assure Safe Use (ETASU) ETASU requirements are the most extensive elements of a REMS program.
How can a registrant become an "authorized collector"?
Eligible registrants must have authority to handle schedule II controlled substances and if they desire to be collectors may do so by modifying their registration to obtain authorization to be a collector. Registrants may modify their registration online at http://www.DEAdiversion.usdoj.gov. Once authorized, these entities are "authorized collectors." Collectors are not authorized to conduct take-back events. Law enforcement may continue to conduct takeback events at any time. Any person or community group, registrant or non-registrant, may partner with law enforcement to conduct take-back events.
What drugs to do you need an "exact count" for? What drugs can you estimate the count?
Exact count for C2 Estimation-C3-C5 unless the vial/bottle size is greater than #1000
Schedule V Controlled Substances Substances in this schedule have a low potential for abuse relative to substances listed in schedule IV and consist primarily of preparations containing limited quantities of certain narcotics. These are generally used for antitussive, antidiarrheal, and analgesic purposes. NAME SOME EXAMPLES:
Examples include cough preparations containing not more than 200 milligrams of codeine per 100 milliliters or per 100 grams (Robitussin AC® and Phenergan with Codeine®).
NAME SOME EXAMPLES OF NON-NARCOTICS SCHEDULE II:
Examples of schedule II stimulants include: 1. amphetamine (Dexedrine®, Adderall®) 2. methamphetamine (Desoxyn®) 3. methylphenidate (Ritalin®) Other schedule II substances include: cocaine, amobarbital, glutethimide, and pentobarbital.
Schedule III Controlled Substances Substances in this schedule have a potential for abuse less than substances in schedules I or II and abuse may lead to moderate or low physical dependence or high psychological dependence. NAME SOME EXAMPLES OF NARCOTIC SCHEDULE III
Examples of schedule III narcotics include combination products containing less than 15 milligrams of and products containing not more than 90 milligrams of codeine per dosage unit (Tylenol with codeine®). Also included are buprenorphine products (Suboxone® and Subutex®) used to treat opioid addiction.
NAME SOME EXAMPLES OF NON-NARCOTIC SCHEDULE III:
Examples of schedule III non-narcotics include benzphetamine (Didrex®), phendimetrazine, ketamine, and anabolic steroids such as oxandrolone (Oxandrin®).
Schedule II Controlled Substances Substances in this schedule have a high potential for abuse which may lead to severe psychological or physical dependence. NAME SOME EXAMPLES OF NARCOTIC SCHEDULE II
Examples of single entity schedule II narcotics include morphine and opium. Other schedule II narcotic substances and their common name brand products include: 1. hydromorphone (Dilaudid®) 2. methadone (Dolophine®) 3. meperidine (Demerol®) 4. oxycodone (OxyContin®) 5. fentanyl (Sublimaze® or Duragesic®). 6. hydrocodone per dosage unit (Vicodin®)
TRUE or FALSE. All schedule drugs must be kept in a locked container at all times in the pharmacy per DEA regulations
FALSE. May be in a locked cabinet or dispersed among non-controlled pharmaceuticals
It's ok to Flush expired or unwanted prescription and over-the-counter drugs down the toilet or drain?
False. Only if the label or accompanying patient information specifically instructs you to do so.
use what form to order scheduled II drugs?
Form DEA 222(must complete for each distribution, purchase or transfer of any C2 drug)
1. Take your prescription drugs out of their original containers. 2. Put the mixture into a disposable container with a lid, such as an empty margarine tub, or into a sealable bag. 3. Mix drugs with an undesirable substance, such as cat litter or used coffee grounds. 4. Conceal or remove any personal information, including Rx number, on the empty containers by covering it with permanent marker or duct tape, or by scratching it off. 5. The sealed container with the drug mixture, and the empty drug containers can now be placed in the trash.
HOUSEHOLD DISPOSAL STEPS
Definition of an emergency situation:
It is necessary for the proper treatment for that patient and no other appropriate alternatives available to treat the patient during that emergency dept.
How do we get from the manufacturer to the patient? MANUFACTURER--->DISTRIBUTOR--->PHARMACIST--->PATIENT
Manufacturer has to be registered with the FDA, the pharmacy has to be registered with the DEA if it contains controlled substances; w/o the DEA certification the pharmacist will be able to only handle non-controlled
The law decreed that FDA would review all types of medical devices existing in 1976 and by regulation place them in Class I, II or III. Class I devices would be subject to various general postmarket controls (e.g., establishment registration, device listing, good manufacturing practice, or GMP). Class II devices would be subject to FDA established performance standards and general postmarket controls. . Class III would need premarket application ("PMA") approval or a completed product development protocol ("PDP") and would adhere to general postmarket controls.
Medical Device Amendment of 1972
• Not usually required as part of a REMS unless the REMS includes ETASU • Required to be dispensed with the drug • Written in non-technical language • Standardized format (font size, headers, etc.) • Provided in addition to general information sheets (Consumer Medication Information or CMI)
Medication Guides
How can I find a collection receptacle location near me?
Members of the public may call the DEA's Registration Call Center at 1-800-882-9539 to find a collection receptacle location near them
Inventory count regarding scheduled drugs:
Must take the inventory at the opening of a business or at the close of business(at the end of the day). Then every (2) years thereafter. CII: exact count CIII-CV: estimation unless the stock bottle contains more than 1000 pills then you must do an exact count.
If a pharmacist is not physically present in the prescription department (helping a patient, taking a break, etc.), does the prescription department have to be locked and alarmed?
No one can be present in the prescription department of a pharmacy, and that prescription department must be locked and alarmed, unless a pharmacist is on duty. The term "on duty" as defined in 18 VAC 110-20-10 means that a pharmacist is on the premises at the address of the permitted pharmacy and is available as needed. Further, 18 VAC 110-20-190 (C) provides the pharmacist on duty the discretion to at all times authorize persons to be present in the prescription department or to disallow any person to be in the prescription department.
Can my pharmacy or other collector force me to give personal information, like my name, my prescription information, or my physician information?
No. A collector may not force anyone to provide any personal information about themselves, their prescription, or their physician. In order to protect personally identifiable information, the DEA encourages persons not to place prescription bottles in collection receptacles or mail-back packages.
Can I dispose of my insulin syringes through one of the disposal methods? What about my child's asthma inhaler?
No. Persons may not dispose of any dangerous, hazardous, or non-compliant items in a collection receptacle or a mail-back package. This includes medical sharps and needles (e.g., insulin syringes), and compressed cylinders or aerosols (e.g., asthma inhalers).
Can I dispose of illicit drugs through a collection receptacle, mail-back package, or take-back event? How can I safely and securely dispose of my unwanted marijuana?
No. Persons may not dispose of illicit drugs (e.g., schedule I controlled substances such as marijuana, heroin, LSD) through any of the three disposal methods. Persons may not dispose of any controlled substances that they do not legally possess. This includes schedules II-V controlled substances that are illegally obtained and possessed.
I don't have a mail-back package, but I remember the address from the last mail-back package I used. Can I mail pharmaceutical controlled substances to that address without an official mail-back package?
No. Persons must use the mail-back package that was provided by an authorized collector or one of their partners. The mail-back package must meet certain specifications, to include having a unique identification number. If an authorized collector receives a sealed mail-back package that they did not provide, the collector must reject it, or if they inadvertently accept it, they must notify the DEA. If persons would like to use a mail-back package and don't possess one, they may contact an authorized collector to obtain one.
Required risk management plans that use risk minimization strategies beyond the professional labeling to ensure that the benefits of certain prescription drugs outweigh their risks.
Risk Evaluation and Mitigation Strategies (REMS)
In VA, may a Schedule VI rx be pre-printed with other information, multiple drugs, check boxes?
Pre-printed pads are fine. Max of 1 drug per pad
Examples of the Types of Risk REMS Requirements Aim to Mitigate
Serious Infection, Severe allergic reaction, liver damage, severe birth defects
What happens to my pharmaceuticals after I dispose of them? Can they be sold, given away, re-packaged, or re-dispensed for use by another patient? Can they be otherwise recycled?
Shall be securely stored or transferred until rendered nonretrievable. They may not be re-sold, donated, repackaged, or re-dispensed. Currently, the most common method of rendering pharmaceutical controlled substances non-retrievable is incineration.
True or False. The DEA Form 41 must be filled out for pharmaceutical waste, which is some of the substance remains in a vial, tube, transdermal patch, or syringe after administration but cannot or may not be further utilized, commonly referred to as "drug wastage" and "pharmaceutical wastage").
Such remaining substance must be properly recorded, stored, and destroyed in accordance with DEA regulations (e.g., 21 C.F.R. 1304.22(c)), and all applicable Federal, State, tribal, and local laws and regulations, although the destruction need not be recorded on a DEA Form 41.
Law explicitly defined two specific categories for medications, legend (prescription) and over-the-counter (OTC). The bill requires any drug that is habit-forming or potentially harmful to be dispensed under the supervision of a health practitioner as a prescription drug and must carry the statement, "Caution: Federal law prohibits dispensing without a prescription." Until this law, there was no requirement that any drug be labeled for sale by prescription only. The amendment defined prescription drugs as those unsafe for self-medication and which should therefore be used only under a doctor's supervision. Legend drugs can only be dispensed with direct medical supervision whereas OTC drugs can be purchased and used without a prescription. This law also legalized verbal transmission of prescriptions and provided for the legal right of a pharmacist to refill prescriptions as indicated in a provider's initial prescription.
The Durham-Humphrey Amendment This amendment was co-sponsored by then Senator (and later Vice President) Hubert H. Humphrey Jr., who was a pharmacist in South Dakota before beginning his political career.[1] The other sponsor of this amendment was Carl Durham, a pharmacist representing North Carolina in the House of Representatives.
a law passed in the United States designed to facilitate the development and commercialization of drugs to treat rare diseases, termed orphan drugs. Orphan drug designation does not indicate that the therapeutic is either safe and effective or legal to manufacture and market in the United States.
The Orphan Drug Act of 1983
was the first of a series of significant consumer protection laws enacted by the Federal Government in the 20th century. Its main purpose was to ban foreign and interstate traffic in adulterated or mislabeled food and drug products, and it directed the U.S. Bureau of Chemistry to inspect products and refer offenders to prosecutors. It required that active ingredients be placed on the label of a drug's packaging and that drugs could not fall below purity levels established by the United States Pharmacopeia or the National Formulary.
The Pure Food and Drug Act of 1906
We as individual pharmacists do not have to register with the DEA to dispense controlled substances from our pharmacy. Who does?
The stores. ex Walgreens, CVS, Walmart Every pharmacy have their own DEA number
A set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics. Also in that year the FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C regulations the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs.
The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C),
May an agent of the prescriber (other than the prescriber) call in a Schedule CIII-V drug?
The oral rx shall be transmitted to the pharmacy of the patient's choice by the prescriber or his authorized agent. An authorized agent of the prescriber shall be an employee of the prescriber who is under his immediate and personal supervision, or if not an employee, an individual who holds a valid license allowing the administration or dispensing of drugs and who is specifically directed by the prescriber.
1) How many ways are there to access a "will-call" prescription in a retail pharmacy setting?
There are 3 ways to access a will-call prescription in a retail pharmacy: a) a pharmacist or clerical associate- a pharmacist, a pharmacy technician, or a designated associate may access the prescription from within the pharmacy while a pharmacist in charge is present. b) a prescription may be stored in a secure place outside the pharmacy in a location where the public may not access it freely. This prescription must be designated only to a designated associate while the pharmacist is not on duty. Written procedures shall be established and followed by the pharmacy that detail the proper compliance with counseling requirements. c) A pharmacy technician may enter the pharmacy and retrieve a designated prescription when a pharmacist is not on duty when accompanied by a member of the pharmacy management or administration team. This prescription must have been dispensed and already verified by a pharmacist. This may ONLY HAPPEN when a pharmacist has an unscheduled absence during a particular time period. The pharmacy technician can only do this once authorized by the Pharmacist in charge or a pharmacist that regularly works at the specific pharmacy. A pharmacy district manager or supervisor who does not regularly work in this department MAY NOT provide authorization to the pharmacy technician. The PIC must have the pharmacy alarm code changed within 48 hours.
I live in a rural location. There are no collection receptacles, mail-back programs, or take-back events in the vicinity. How can I safely and securely dispose of my unwanted pharmaceutical controlled substances?
There are no restrictions on using a mail-back package obtained from another state. You may dispose of your unwanted pharmaceutical controlled substances in a mail-back package that you received from another state, even if the mail-back package is delivered to a location outside of your state.
form 106?
This form must be used by registrants to report the THEFT or LOSS of any controlled substance, including sealed inner liners and returned mail-back packages. It has been updated to include the collection of information relevant to lost or stolen sealed inner liners and returned mailback packages.
Who am I? When transporting to destroy controlled substances at an off-site location, two employees of the registrant must accompany the controlled substances, observe the loading and unloading of the controlled substances, and observe the destruction of the controlled substances. Additionally, the names and signatures of the two employees that witnessed the destruction must be recorded on DEA Form 41.
Two-Person Integrity Requirement for Transport and Destruction
Does VA require a proof of identity when picking up a prescription?
VA: Must provide proof of inspection CII: Must request proof of identity. Must record the person's name and address CIII-V: May request proof of identity
May a pharmacist administer a vaccine in Virginia?
Yes
May you continue to dispense a prescription when the physician dies?
Yes, because physician death, retirement or loss of license does not void prescription written prior to the date the physician ceased practicing. So, the pharmacist can fill the prescription and any authorized refills as long as the pharmacist use his professional judgment and the prescription was written for a legitimate medical purpose and pursuant to a valid physician-patient relationship.
May you continue to dispense a prescription when the physician relocates to a different state?
Yes, because physician death, retirement or loss of license does not void prescription written prior to the date the physician ceased practicing. So, the pharmacist can fill the prescription and any authorized refills as long as the pharmacist use his professional judgment and the prescription was written for a legitimate medical purpose and pursuant to a valid physician-patient relationship.
May you continue to dispense a prescription when the physician's license is suspended/revoked?
Yes, because physician death, retirement or loss of license does not void prescription written prior to the date the physician ceased practicing. So, the pharmacist can fill the prescription and any authorized refills as long as the pharmacist use his professional judgment and the prescription was written for a legitimate medical purpose and pursuant to a valid physician-patient relationship.
My mother has pharmaceutical controlled substances delivered to her home. She passed away, and I would like to dispose of her unused pharmaceutical controlled substances. I did not live with her. Can I dispose of them?
Yes, so long as you are lawfully entitled to dispose of her property, you may dispose of her unused pharmaceutical controlled substances.
Can a pharmacy set up an answering machine for prescribers to leave oral prescriptions or refill authorizations?
Yes, the Board considered this issue and determined that an oral prescription may be left by a prescriber on a voice recording device or on voice mail provided the pharmacist personally takes the prescription information off the recorder or voice mail and transcribes the oral prescription to a written hard copy.
May a prescription be issued with refills for up to two year?
Yes. Effective January 11, 2006, a prescription for a Schedule VI drug or device is valid for one year from the date of issuance unless the prescriber specifically indicates for a longer period of time, not to exceed two years.
VA 2015, does it need to have specific types of CE's?
Yes. Pharmacists are required to obtain at least 1 hour of CE in the topic of "opioid use or abuse"
Can a pharmacy return dispensed prescriptions from "will call" to stock for re-dispensing if the patient never picks up the prescription?
Yes. Regulation 18VAC110-20-355 D allows the restocking of drugs from will-call provided the pharmacy places an expiration date on the label which in the absence of stability data to the contrary, shall not exceed the expiration date on the manufacturer's container or one year from the date the drug was originally dispensed, whichever date is earlier. The restocked drug should be used to fill the next prescription received for that product. In the event that the drug is not dispensed prior to the new assigned expiration date, it shall be removed from stock and destroyed or otherwise disposed of in accordance with regulations. If there is no lot number on the label of a drug returned to stock or on the prescription records which can be cross referenced from the prescription label, the drug will be removed from stock upon any recall of that drug product and returned to the manufacturer or otherwise disposed of in accordance with regulations.
If a prescriber wants the brand-name drug to be dispensed (as opposed to a generic) can the prescriber put the phrase "Brand Medically Necessary" in the form of a check-box on the prescription pad or "stamp" the phrase on the prescription?
Yes. The law does not state in what form the phrase should appear. However, the prescriber must handwrite the phrase in order to ensure payment for a branded product for Medicaid patients when there are generics available in the marketplace.
Is it true that anybody can dispose of a friend's unused or unwanted pharmaceutical controlled substances
You may dispose of a member of your household's unused or unwanted pharmaceutical controlled substances. But, if they are not a member of your household, you may not dispose of their pharmaceutical controlled substances on their behalf. Only ultimate users may dispose of pharmaceutical controlled substances
May a physician prescribe a CII - CV drug for family or self?
["Physicians generally should Not treat themselves or members of their immediate family." Exceptions: Short-term, minor problems, or in emergency or isolated settings.] No. Schedule I, II, or IV drugs should be prescribed unless an emergency For Virginia: Shall Not prescribe a controlled substance other than a schedule VI Exceptions: Emergency or isolated setting where no other practitioner is available. Or if for a single episode of an acute illness Must be documented
Who is an "ultimate user"?
a person who has lawfully obtained, and who possesses, a controlled substance for his own use or for the use of a member of his household or for an animal owned by him or a member of his household.
A reverse distributor will be defined:
as a person registered as a reverse distributor.
The final rule for destruction of Controlled Substances, implements a standard of destruction:
non-retrievable(incineration) [The process utilized to render a substance "non-retrievable" shall permanently alter the substance's physical or chemical condition or state through irreversible means and thereby render the substance unavailable and unusable for all practical purposes. A substance is considered "non-retrievable" when it cannot be transformed to a physical or chemical condition or state as a controlled substance or controlled substance analogue. ]
red flags
paying with cash, excessive quantities, certain combinations that dont go together, :ex The holy trinity
the corresponding responsibility doctrine
pharmacist must only dispense valid controlled substances prescriptions. must look out for 'red flags' . you can lose your license
DEA form 224
submit to the DEA to register to be able to handle controlled substances
What changes, if any, is a pharmacist permitted to make to a CII drug in Virginia?
the drugs strength the dose of the drug the frequency
Reverse distribute means:
to acquire controlled substances from another registrant or law enforcement for the purpose of return or destruction.
How long is a CII prescription valid for in Virginia?
up to 6 months