Pharmacy Regulations on Beyond-Use Dating

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Questions and Answers

What is the maximum beyond-use date suggested by the USP?

One year from the date the drug is dispensed. (correct)

Two years from the date the drug is dispensed.

The expiration date on the manufacturer's container. (correct)

One year from the date of repackaging.

How does Pennsylvania law differ from USP guidelines regarding expiration dates?

Pharmacists must use a ‘do not use after’ label only if the expiration is less than one year. (correct)

Pennsylvania does not require any expiration dates to be labeled.

Pharmacists are required to follow USP guidelines strictly.

The pharmacist must dispense all drugs with a minimum expiration of one year.

What should the label on a drug indicate if its full potency is less than one year at dispensing?

This drug has no expiration date.

Use as directed until the expiration date.

Safe to use for one year post-dispensing.

Do not use after (manufacturer's expiration date). (correct)

For unit-dose containers, what is the earlier beyond-use date determined by?

One year from the date of repackaging or the expiration on the bulk container. Signup and view all the answers

What is the FDA's view on beyond-use dating as referenced in the content?

The beyond-use date should not exceed 6 months or 25% of the remaining time. Signup and view all the answers

What type of containers complicates the beyond-use dating process according to the discussed guidelines?

PVC containers. Signup and view all the answers

What is required for unit dose containers that are repackaged from a manufacturer's container with a one-year expiration?

The beyond-use date must be set to no more than three months. Signup and view all the answers

Which condition affects the unit dose beyond-use date guidelines from USP?

Material used in the container. Signup and view all the answers

What is a responsibility of a pharmacist when presented with a prescription from a healthcare professional outside their scope of practice?

Take the prescription back and refuse to dispense it. Signup and view all the answers

Which of the following substances can CRNPs prescribe?

Schedule II substances for up to 30 days Signup and view all the answers

What does the negative formulary for CRNPs entail?

A list of drugs they are prohibited from prescribing. Signup and view all the answers

When is it appropriate for a dentist to prescribe medications outside their usual scope of practice?

It is never appropriate. Signup and view all the answers

What is typically the duration for which CRNPs can prescribe Schedule III to V substances?

90 days Signup and view all the answers

How should a pharmacist respond to a prescription that appears to be a favor for a patient rather than a legitimate medical need?

Decline to dispense it immediately. Signup and view all the answers

What should pharmacists always be vigilant about when dealing with prescriptions from mid-level practitioners?

The prescriptive rights related to controlled substances. Signup and view all the answers

What is a common misconception regarding dentists prescribing medications?

Dentists can prescribe medications unrelated to dental issues. Signup and view all the answers

What action regarding drug samples is prohibited under the PDMA?

Selling, purchasing, or trading drug samples Signup and view all the answers

What specific requirement must be fulfilled when hospital pharmacies receive samples?

Documentation including name and address of the requesting doctor Signup and view all the answers

What is the significance of a paper trail established by the PDMA?

To track the distribution of samples from manufacturers to patients Signup and view all the answers

Who is permitted to have drug samples according to the PDMA?

Hospital pharmacies Signup and view all the answers

What happens if drug samples are found in a retail pharmacy?

It is considered a violation of the PDMA Signup and view all the answers

What type of orders for drug samples are not allowed under the PDMA?

Standing orders Signup and view all the answers

Which entity must be licensed at the state level according to the PDMA?

Wholesalers Signup and view all the answers

What is required in terms of record keeping for drug samples under the PDMA?

Strict storage and handling records Signup and view all the answers

What is the most common way for a manufacturer to change a drug from prescription to over-the-counter status?

Through a supplemental application to the FDA Signup and view all the answers

What does a manufacturer gain if the FDA approves their supplemental application for OTC status?

Over the counter marketing exclusivity Signup and view all the answers

What must pharmacists consider when dispensing medications that are similar but differ in status?

The status of the products as prescription or OTC Signup and view all the answers

How else can a product transition from prescription to over-the-counter status apart from the supplemental NDA process?

By petitioning the FDA directly Signup and view all the answers

Which of the following statements is true regarding prescription refill authorization?

A nurse can transmit refill authorizations on behalf of a doctor Signup and view all the answers

Why is it illegal for a physician to delegate their prescriptive authority?

To prevent potential misuse of medications Signup and view all the answers

What is a potential consequence if an identical product remains prescription while another is OTC?

Pharmacists may dispense the prescription product without checking Signup and view all the answers

What was the main outcome of the district court's ruling on the FDAMA section?

It ruled sections of FDAMA unconstitutional. Signup and view all the answers

What is NOT a method for a drug transitioning from prescription to OTC status?

Public voting on the drug's status Signup and view all the answers

What action did the FDA take following the Supreme Court's silence on the remainder of the compounding provisions?

They reverted to an older Compliance Policy Guide. Signup and view all the answers

What is considered a key factor that could make the FDA investigate a compounding pharmacy?

Stockpiling drug products in large quantities. Signup and view all the answers

Which of the following activities could lead to FDA investigation regarding compounding?

Compounding unsafe drugs previously removed from the market. Signup and view all the answers

What must a compounding pharmacy ensure about its drug substance suppliers?

They must be FDA registered facilities. Signup and view all the answers

Which of the following practices would likely be viewed with suspicion by the FDA?

Using commercial equipment for compounding. Signup and view all the answers

What type of drug compounding is particularly discouraged for pharmacies?

Offering compounded products to third parties for resale. Signup and view all the answers

What could be a violation related to compounding drugs that might trigger scrutiny from the FDA?

Using drug components that do not meet official compendial requirements. Signup and view all the answers

Study Notes

Beyond-Use Dating

The USP suggests a beyond-use date that’s not later than the expiration date on the manufacturer’s container or one year from the date that the drug is dispensed, whichever is earlier.
Pennsylvania does not require an automatic expiration date, and the pharmacist only needs to add language such as ‘do not use after’ when the manufacturer expiration date is less than one year from the date of dispensing.
The beyond-use date for a unit dose container is the earlier of one year from the date of repackaging or the expiration date on the bulk container.
The FDA’s previous rule stated that the beyond-use date was not to exceed 6 months, and that the beyond-use date was also not to exceed 25% of the remaining time between the date of repackaging and the expiration date on the unopened original manufacturer’s container.

Prescription to OTC Status

The most common way for a product to switch from prescription to OTC status is for the manufacturer to request the FDA to make that status change through a supplemental application to the original NDA.
If the FDA does grant approval for a supplemental application, that effectively grants over-the-counter marketing exclusivity to a manufacturer compared to a similar manufacturer, which might be marketing an identical prescription product.
The second way a product can go from prescription to OTC status is for the manufacturer to simply ask or petition the FDA to make it happen, instead of going through the supplemental NDA process.

Prescriptive Authority

Physicians cannot delegate their prescriptive authority.
Agents can freely transmit any refill authorization to the pharmacist.

Scope of Practice

CRNP’s (Certified Registered Nurse Practitioners) have a negative formulary, meaning that there’s a group of drugs from which they cannot prescribe, meaning, gold compounds, heavy metal antagonists, radioactive agents or oxytocics.
CRNP’s can prescribe Schedule II substances for up to 30 days and Schedule III through V for up to 90 days.

Compounding

The FDA announced that they were simply going to revert back to an earlier Compliance Policy Guide, which re-emphasized to the pharmacist community that the FDA will continue to defer to state authorities unless there were violations related to compounding that were enumerated in the policy guide.
The FDA looked very suspect at any pharmacy that was compounding in anticipation of receiving prescriptions, unless done in limited quantities that were consistent with past dispensing practices.
The FDA was also concerned to make sure that you weren’t compounding using any drugs that have been previously removed from the market for safety reasons.

PDMA

The PDMA (Prescription Drug Marketing Act) was designed to regulate the distribution of samples and also regulate the purchase and resale of drugs that were purchased by non-profit entities such as hospitals.
The sale, purchase or trade of samples was strictly prohibited including even the offer to sell.
Hospital pharmacies are allowed to have samples. However, accompanying the sample, there must be a receipt of the name and address of the doctor that prescribed it or requested it, the name of the hospital designated to receive the sample, name, address and title of the person acknowledging receipt of that sample, the established name of the drug, quantity, lot number and delivery date.

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Description

This quiz covers the regulations surrounding beyond-use dating for prescription medications and how it varies by state. Learn about the guidelines set by the USP and FDA, and the factors affecting the expiration dates of medications. Test your knowledge on these important pharmacy practices.