Federal Pharmacy Law

According to federal law, C-II prescriptions must be frilled within how many days after being signed by the prescriber?

Federal law places no time limit within which a C-II prescription must be filled (I.e. the prescription is considered valid for an unlimited period of time after it is issued). *There is one exception: long term care facility patients with a terminal illness. Schedule II prescriptions for these patients are only valid for 60 days for the date issued.

Monthly (30-day sales) of pseudoephedrine are limited to what amount?

Federal law states 9 grams. Note: Tennessee state law is more stringent. 30-day limit is 5.76 grams with an annual limit of 28.8 grams. Pharmacies are expected to follow the more stringent law, which in this case, is the state law.

FDA recall (class II)

Possibility that use of (or exposure to) the recalled product could cause temporary or medically reversible adverse health consequences.

How did the Omnibus Reconciliation Act of 1990 (OBRA '90) change pharmacy practice?

Requiring drug utilization reviews (DUR) and pharmaceutical care (I.e. pharmacist counseling) for Medicaid patients.

What do you do when you have a medication with a very high level of risk that has a tremendous benefit for some patients?

Restricted drug programs! REMS — Risk Evaluation and Mitigation Strategies. The FDA, pursuant to the FDA Amendments Act of 2007, can require manufacturers to comply with REMS to manage the risks associated with certain drugs. REMS are meant to ensure that the benefits of using a particular medication outweigh the associated risks.

What are some of the most well-known and frequently used REMS programs?

iPLEDGE, THALIDOMID REMS, T.I.P.S., Clozaril National Registry

To comply with federal regulations, what information must be logged in the record book to comply with C-V controlled substances are sold without a prescription?

- Name and address of purchaser. - Name and quantity of controlled substance purchased. - Date of purchase. - Name or initials of the pharmacist dispensing the substance.

What rules come from the Controlled Substance Act of 1970?

- Records for controlled substances must be kept separate from other prescription records. - You can only do a partial fill for Schedule II drugs if the remainder can be filled within 72 hours. + if a partial fill was given, but the remainder cannot be filled within 72 hours, the prescriber must be notified. - Schedule III, IV, and V drugs can be transferred to another pharmacy only one time. Note: Transfers are unlimited for pharmacies that share a real-time, online database.

What color is each copy/slip of the DEA Form 222?

- The first page (original) is brown. - The second page (first carbon copy) is green. - The third page (second carbon copy) is blue.

"Minimum necessary use and disclosure" does not apply to certain situations which include:

-Disclosures to a healthcare provider for treatment. -Disclosures to the patient upon request. -Disclosures authorized by the patient. -Disclosures necessary to comply with other laws. -Disclosures to the Dept. of Health and Human Services (HHS) for compliance investigation, review, and enforcement.

What information must be logged during the sale of products containing pseudoephedrine?

-Product name. -Quantity sold. -Name and address of purchaser. -Date and time of sale. -Signature of purchaser.

There are three exceptions which allow for C-II facsimile prescriptions to serve as the original prescription - what are they?

1. The prescription is being compounded for home infusion. 2. The prescription is for a patient in a long-term care facility. 3. The prescription is for a patient enrolled in a hospice care program.

How many carbon copies are attached to the DEA Form 222?

2 carbon copies (I.e. the original plus 2 copies).

According to federal law, how long are pharmacies required to keep controlled substance records (I.e. return records, prescription records, and inventory records)?

2 years.

How long are you required to keep the 222 forms in your pharmacy?

2 years.

The C-V record book must be maintained for a period of how long?

2 years.

Records from pseudoephedrine sales must be kept for what length of time.

2 years. Note: state law indicates that this information must be maintained for a period of 1 year, but federal law says 2 years. Pharmacies must follow the more stringent requirement and maintain records for 2 years.

Daily sales of pseudoephedrine are limited to what amount?

3.6 grams per day.

When emergency C-II prescriptions are called in, a prescriber has how many days to furnish the pharmacy with a written/signed prescription?

7 days according to federal law.

Federal law limits the amount of pseudoephedrine purchased via mail order to what amount over a 30-day period.

7.5 grams, Note, once again TN state law limits 30-day sales to 5.76 grams.

What is iPLEDGE?

A REMS program aimed at ensuring patients beginning isotretinoin therapy are not pregnant and preventing pregnancy in patients receiving isotretinoin therapy. Retinoids cause SEVERE birth defects.

Clozaril National Registry

A database where WBC for patents receiving therapy is monitored. Has the potentially fatal side effect of agranulocytosis (suppression of WBC production), so WBC must be measured by medical professionals and recorded in the national registry every week for the first 6 months of therapy and then periodically thereafter. Pharmacies can only dispense enough drug to treat the patient until their next scheduled lab work. This program has been referred to as the "no blood, no drug" program.

What is an "adulterated" drug?

A drug that has a quantity, strength, or purity that is different from that which is stated on the label.

What consequence can a manufacturer face for failing to comply with REMS?

A fine of at least $250,000 per incident.

What is the DEA Form 224 used for?

Applying for pharmacy DEA registration.

After an initial inventory of controlled substances has been taken (e.g. when the pharmacy first opens for business), how frequently must an invent of controlled substances be taken?

At least every two years.

Pseudoephedrine can only be purchased from what location?

Behind the pharmacy counter or from a locked cabinet stored away from customers.

What is one of the major issue surrounding bio-identical hormone compounding?

Bio-identical hormone formulations contain estradiol, estrone, estriol, progesterone, and testosterone. Estriol is a non-FDA approved drug, so compounding with estriol is illegal.

How did the Omnibus Reconciliation Act of 1990 (OBRA '90) change pharmacy practice?

By requiring drug utilization reviews (DUR) and pharmaceutical care (I.e. pharmacist counseling) for Medicaid patients.

What is the most serious class of FDA recall?

Class I recall.

What is the DEA Form 104 used for?

Closing a pharmacy/surrendering a pharmacy permit.

A drug that is compounded cannot be a copy of a ______________________________________.

Commercially available product.

When Schedule II controlled substances are sent to a reverse distributor because they are expired, damaged, or otherwise unusable, what form should be used?

DEA Form 222. Remember - for CIIs, its a form 2. Form 222 for C2s!

How do I know if a DEA number is valid?

DEA Letters: + First letter: - A, B, F: Physicians, dentists, veterinarians, hospitals, and pharmacies - M: mid level practitioners - P or R: drug distributors - X: Suboxone/Subutex provider + Second letter: Same as the first letter of the prescriber's last name or the first letter in the name of the business. DEA numbers: Step 1: Add the 2nd, 4th, and 6th digits of the DEA number, and multiply the sum by 2. Step 2: Add the 1st, 3rd, and 5th digits of the DEA number. Step 3: Add the numbers you get from step 1 and 2 to get you final answer. Step 4: The number should be a 2 digit number. If the DEA number is valid, the second digit from your two digit answer will match the 7th and final digit from the DEA number.

Which medical professionals have prescribing authority?

Doctor of Medicine (MD) Doctor of Osteopathic Medicine (DO) Doctor of Dental Medicine (DMD) Doctor of Dental Surgery (DDS) Doctor of Optometry (OD) Doctor of Podiatric Medicine (DPM) Doctor of Veterinary Medicine (DVM) Physician Assistant (PA) Nurse Practitioner (NP)

Thalidomid REMS (formerly known as S.T.E.P.S)

Drug causes severe birth defects in unborn babies and VTE in patients using the drug.

State Board of Pharmacy role —

Each state has it's own BoP which is responsible for protecting the health, safety, and welfare of it's CITIZENS in matters related to pharmacy. This is accomplished through licensing and the enforcement of state and federal pharmacy laws, rules, and regulations.

How frequently does a pharmacy's DEA registration need to be renewed?

Every 3 years.

What was a major effect of the Kefauver-Harris Amendment (1962)?

Evidence of effectiveness must be provided by drug manufacturers before a drug can be sold.

True or false. Refills for C-II prescriptions are permitted by federal law (up to 5 refills in 6 months).

FALSE. Refills for C-IIs are prohibited by federal law. That is the rule for C-III through C-V.

True or false. For controlled substance prescriptions, the maximum quantity that can be dispensed according to federal law is a 30-days supply.

False, although some states and insurance carriers limit controlled substance quantities to a 30-day supply, there are NO specific federal limits. In Tennessee, Public Chapter 430 of the Tennessee Code places a maximum dispensing limit of a 30-day supply on any opioid or benzodiazepine. For Schedule II drugs this means there is a 30-day supply dispensing limit on drugs like oxycodone of fentanyl, but no limit on drugs like methylphenidate or amphetamine.

True or false. Pseudoephedrine can be purchased without a photo ID.

False.

True or false. Federal law prohibits e-prescribing of C-II drugs.

False. Federal law permits e-prescribing of C-II drugs provided that the prescriber and pharmacy use e-prescription software that meets DEA requirements.

True or false. Schedule I controlled substances can be dispensed pursuant to a valid, hand-signed prescription.

False. Schedule I controlled substances have no accepted medical use and cannot be prescribed.

True or false. Schedule II controlled substance prescription records can be stored in the same file as all other prescription medications.

False. Schedule II prescription records must be stored separate from all other prescription records.

True or false. A pharmacy can advertise compounding of a type of drug (e.g. "We compound bio-identical hormone replacement products").

False. You would need to be registered as a manufacturer to advertise in this manner. A pharmacy cannot promote the compounding of any specific drug, drug class, or type of drug.

When ordering Schedule II drugs for your pharmacy, what do you do with the first two pages (brown and green) of the DEA Form 222?

Give them to the supplier without separating them. For the form to be valid from the supplier's perspective, the brown and green copies must be intact with the carbon paper in between.

What did the Durham-Humphrey Amendment (1951) accomplish?

Led to the creation of two drug categories: OTC (over-the-counter) and Prescription/Legend (Rx) drugs. Note: This amendment also required Rx drugs to have the words "Caution: Federal law prohibits dispensing without a prescription" on the label.

What is a "misbranded" drug?

Many things can be construed as misbranding. Beliw is a list of some examples. - False or misleading labeling. - Noncompliant packaging/labeling. - Unclear wording on the label. - Inadequate directions for use. - Drug poses a danger if used as prescribed. - Generic name is not displayed in font at least half as large as the brand name font.

Why are nitroglycerin sublingual tablets exempt from the PPPA?

Nitroglycerin sublingual tablets are used to restore blood flow to the heart during an exacerbation of angina (characterized by acute chest pain), potentially preventing a myocardial infarction (heart attack). Child resistant packaging may cause an individual on the verge of a heart attack to struggle with opening the container of a potentially life-saving medication (nitroglycerin). As a result, this medication is exempt from the rules of the PPPA.

Do all REMS programs require as much work as the iPLEDGE, THALIDOMID REMS, TIPS, Clozaril National Registry program?

No! In fact, some drugs have REMS programs that are so simple you would be surprised they are considered REMS programs at all. One example is the Dulera program. The only requirement of the Dulera REMS is that the increased risk of asthma-related death with the use of LABA be communicated to all healthcare professionals and prescribers.

When Schedule III-V controlled substances are returned, is a DEA Form 222 necessary?

No, Schedule III-V Controlled substances may be transferred using only an invoice (a DEA form 222 is only used for Schedule I and II controlled substances).

Can a controlled substance be delivered or shipped to an individual in another country if it is dispensed or pursuant to a valid prescription?

No, exportation of a controlled substance is prohibited by federal controlled substances act.

If you make a mistake when filling out a DEA Form 222 can you just cross out the error?

No, if an error is made then all the copies of the Form 222 must be voided and retained in your records.

Can dentists prescribe medications to treat depression?

No, prescribers cannot prescribe medications to treat conditions outside of their scope of practice. For instance, a DVM cannot prescribe medications for humans. A DPM cannot prescribe medications to treat conditions for the eye. Note: In some states, some other healthcare professionals may have prescriptive authority, like certified nurse-midwives. *YOU NEED TO LOOK THIS UP AND KNOW TN PRESCRIPTIVE AUTHORITY.

Can a prescriber post-date a prescription for a controlled substance (e.g. record the date of issuance as 8/15 if he actually wrote it and signed it on 8/10)?

No, the prescription must be dated on the day it is actually signed.

You compound a drug without a prescription. Is this ok?

No, this would be considered manufacturing. When compounding, you need to be compounding for a specific prescription.

Vioxx (rofexocib) was taken off the market due to safety concerns. Would it be legal to compound a product containing rofecoxib?

No. The FDA prohibits compounding of drugs that have been deemed unsafe or ineffective.

Occupational Safety and Health Administration (OSHA) role —

OSHA enforces health and safety laws. The most important topic OSHA deals with in pharmacy is minimizing the risk of employee exposure to blood born pathogens. This is particularly relevant to pharmacies that compound infusions and/or administer vaccinations.

What were the shortcomings of the Pure Food and Drug Act of 1906?

Only PURITY was addressed. Safety was not addressed. Therapeutic false claims were not prohibited.

Are verbal/oral orders for C-II controlled substances permitted by law?

Only in emergency situations. Note: quantity prescribed must be limited to the amount adequate to treat the patient for the duration of the emergency period, up to a 72-hour supply.

What is a DEA Form 222 used for?

Ordering Schedule I and Schedule II controlled substances.

What is the DEA Form 222a used for?

Ordering more DEA Form 222 forms.

Approximately how many drugs have a REMS program?

Over 100 drugs.

After calling in an emergency C-II prescription, what must the prescriber do next?

Provide the pharmacy with a written and signed hard copy, which the pharmacy attaches to and files with the verbal order.

FDA recall (class I)

Reasonable probability that use of (or exposure to) the recalled product will cause serous adverse health consequences up to and including death. *An easy way to remember this is that level 1 trauma is the worst*

What is the DEA Form 41 used for?

Reporting the destruction of controlled substances?

What is the DEA Form 106 used for?

Reporting theft or loss of controlled substances.

When using or disclosing PHI, what principle should you keep in mind?

The principle of "minimum necessary use and disclosure".

OBRA '90 only requires an offer for pharmacist counseling to be made to Medicaid patients, but why does EVERY customer, including non-Medicaid customers, receive the same offer?

The "offer to counsel" became part of standard pharmacy business to ensure that all customers were receiving the same level of service.

What is the name of the law that limits opioid and benzodiazepine dispensing to a 30-day supply in TN?

The Addison Sharp Prescription Regulatory Act of 2013.

Drug Enforcement Administration (DEA) role —

The DEA enforces the Federal Controlled Substance Act, and determines which drugs are placed on the federal controlled substance schedule.

What should be done in the event that a theft of loss of a controlled substance is discovered?

The DEA should be notified upon discovery of the theft/loss and a DEA form 106 should be completed to document the theft/loss.

Food and Drug Administration (FDA) role —

The FDA enforces drug manufacturing laws and regulates prescription advertising know as "direct to consumer" (DTC) advertising.

Manufacturers of bulk products used in compounding must be registered with ________________.

The FDA.

Federal Trade Commission (FTC) role —

The FTC is in charge of regulating advertisement of OTC drugs, medical devices, cosmetics, and foods. Note: Vitamins and herbal supplements are considered to be "food" in the eyes of the law.

What is the intent of the PPPA?

The PPPA is intended to protect children form serious injury or illness caused by handling, using, or ingesting medications and certain household substances.

How is this accomplished?

The PPPA protects children by requiring manufacturers to use packaging that is significantly difficult for children under the age of 5 years old to open, yet not difficult for normal adults to open.

Which part of the DEA Form 222 is the supplier required to retain?

The first page (brown copy).

If an individuals PHI has been breached, what must be done according to HIPAA?

The individual must be notified by the person or entity holding the information that their PHI was exposed. This is known as the HIPAA Breach Notification Rule.

When federal and state laws say different things, which law applies?

The more stringent law! For example, The Meth-Free TN Act of 2005 says that pseudoephedrine sales records must be maintained for a period of 1 year, but the federal Combat Methamphetamine Epidemic Act of 2005 says you have to maintain records for 2 years. ALWAYS FOLLOW THE MORE STRINGENT LAW.

In what setting might you find Schedule I controlled substances?

The only place Schedule I controlled substances can be legally utilized is in a legitimate research laboratory registered with and authorized by the DEA to use Schedule I controlled substances in research.

Who would be responsible for filling out the DEA Form 222?

The reverse distributor. Note: the entity receiving the Schedule II controlled substance is always the one responsible for filling out the 222 form.

Which part of the DEA Form 222 does the supplier forward to the DEA?

The second page (green copy).

What historical event led to the Food, Drug, and Cosmetic Act of 1938 (FDCA)?

The sulfanilamide disaster, in which over 100 people died from using an elixir of sulfanilamide dissolved in diethylene glycol (I.e. antifreeze).

What is the purpose of the Health Insurance Portability and Accountability of 1996 (HIPAA) Act?

To protect the privacy of individual health information (referred to in the law as protected health information or PHI).

Which part of the DEA Form 222 is the pharmacy required to retain?

The third page (the blue copy) *Easy way to remember that the pharmacy keeps the BLUE copy is that it's my favorite color!

Prescribers that want to prescribe Schedule III through V controlled substances for treatment of narcotic addiction (I.e. buprenorphine) must display what piece of additional information on the face of the prescription?

Their unique DEA registration identification number that begins with an X which is granted to prescribers that have obtained the necessary waiver* from the DEA (in addition to their standard DEA registration number). *Typically, controlled substances used to treat narcotic addiction can only be prescribed, administered, and/or dispensed from within a Narcotic Treatment Facility (NTF), but the DEA can grant waiver to prescribers allowing them to prescribe, administer, and or dispense CIII-V drugs for the treatment of narcotic addiction outside of a NTF.

What packaging requirement applies to solid oral dosage forms of pseudoephedrine?

They must be packaged and sold in blister packs, pseudoephedrine can never be sold as loose tablets/capsules.

How did the Food and Drug Administration Modernization Act of 1997 change prescription labeling?

This act allowed the statement "Caution Federal law prohibits dispensing without a prescription" to be shortened/reduced to "Rx only".

How did the Poison Prevention Packaging Act (PPPA) of 1970 change the way we dispense drugs?

This act required drugs to be dispensed in child-resistant packaging (there are several exceptions, one exception is nitroglycerin sublingual tablets).

How did the Poison Prevention Packaging Act of 1970 change the way we dispense drugs?

This act requires drugs to be dispensed in child-resistant packaging (there are a few exceptions you should know - one of which is nitroglycerin sublingual tablets).

What impact did the Food, Drug, and Cosmetic Act of 1938 have on pharmacy?

This legislation required drug manufacturers to prove the safety of a drug via a New Drug Application (NDA) before a drug could be sold.

T.I.P.S REMS

Tikosyn in Pharmacy System — communicating the risk of induced arrhythmia with the use of Tikosyn (dofetilide). It can actually cause potentially fatal ventricular arrhythmias.

What is the purpose of the Health Insurance Portability and Accountability Act of 1996 (HIPAA)?

To keep protected health information (PHI) confidential and secure.

FDA recall (class III)

Use of the recalled product is unlikely to cause adverse health consequences.

When taking an inventory of controlled substances, does the law require you account for drug samples?

Yes, drug samples of controlled substances must be accounted for in the inventory record.

According to federal law, can any controlled substances be sold to patients without a prescription?

Yes, limited quantities of Schedule V controlled substances (I.e. in a 48 hour period, up to 240 mL or 48 dosage units of an opium-containing product or 120 mL or 24 dosage units of another Schedule V controlled substance) may be dispensed by a pharmacist to a customer 18 years of age or older without a prescription. Note: The pharmacist must log each sale in a record book and, if the customer is not known by the pharmacist, he/she must present suitable identification.

When a person picks up a prescription for a controlled substance from the pharmacy, is he/she required to show identification?

Yes, when the prescription is a C-II though C-V opioid, benzodiazepine, barbiturate, or zolpidem or carisoprodol, the individual picking up the medication is required to show identification for supplies > 7 days.* *Exceptions to the above include: +The individual is known by the dispenser. +The individual does not have an ID because he/she is homeless. +The individual does not have an ID because he/she is a minor.

Can manufacturers require their own REMS program without being required by the FDA to create such a program?

Yes.

Does HIPAA set standards for protecting electronic PHI such as electronic medical records?

Yes.

What does the Prescription Drug Marketing Act of 1987 say?

You cannot sell, buy, or trade drug samples. Note: violation can result in a $250,000 fine and a 10-year prison sentence.