3 Pharmacy Laws to Know for the PTCB Exam!

PTCB Pharmacy Law

Pharmacy law is a key part of one of the four knowledge domains of the PTCB exam . If you intend on succeeding at the exam, you must learn the fundamental legislation and what impact those laws have had. Here, we review some essential pharmacy laws to know for the PTCB exam.

Many students find pharmacy law difficult.

Sure – it’s not the most exciting and dynamic subject to study. That said, pharmacy technicians need to understand how the pharmacy profession has advanced and why they are obliged to work under specific protocols.

Once you begin to appreciate the relevance of pharmacy law, your PTCB exam study becomes much easier. There are 90 questions on the PTCB exam, with pharmacy law accounting for 10 of those questions; a sizable 11.1% of the test.

Below, we review some of the essential legislation that you need to know. We review 3 core pieces of legislation that always gets examined.

If you would like to test your knowledge of pharmacy law, we’ve put together a complete course of PTCB exam questions and full-length practice tests to help you master this part and every other subject of the PTCB exam.

Now though, let’s delve deeper into some must-know legislation. This legislation covers:

• Durham-Humphrey Amendment, 1951
• Kefauver-Harris Amendment, 1963
• Poison Prevention Packaging Act, 1970

Let’s get started.

#1 – Durham-Humphrey Amendment, 1951

The Durham-Humphrey amendment, enacted in 1951, was an amendment to the Food, Drug and Cosmetic Act.

This was a much-needed amendment. Up until 1951, many prescription drugs were given to patients in the same manner as OTC medicines. There were no specific guidelines or regulations in place to tightly control how and when prescription drugs were dispensed. Pharmacies were dispensing prescription drugs to patients who did not have a prescription.

This amendment changed that.

Senators Hubert Humphrey and Carl Dunham – to whom the amendment owes its name – established clear criteria as to what constituted a “prescription drug” and the circumstances in which it can be dispensed to a patient. It outlawed the action of dispensing a prescription (“legend”) drug to those who did not have a prescription – remedying this long-standing problem.

The label, “Caution: Federal law prohibits dispensing this medication without a prescription”, would now have to be present on all prescription medicines.

Furthermore, the amendment also permitted prescriptions to be made over the phone, via oral transmission. Similarly, it allowed refills to be called in from a physician’s office. These were substantial, but much-needed improvements to existing legislation.

This amendment is commonly asked on the PTCB exam. You need to know why the amendment was put forth, what problems it solved, and what other practical functions it had.

#2 – Kefauver-Harris Amendment, 1963

The Kefauver-Harris amendment was enacted in 1963; one of the most important pharmacy laws to know for the PTCB exam.

This amendment was passed because dubious and potentially lethal medicines were being sold to the public. The amendment sought to guarantee the safety, purity, and efficacy of both prescription and non-prescription medicines; eliminating the risk of dubious or harmful medicines being released into the public sphere.

The amendment was also passed in the wake of the thalidomide tragedy, in which tens of thousands of birth defects were caused by thalidomide; a drug marketed to pregnant women for the treatment of morning sickness.

Thalidomide is a teratogenic drug; meaning that it is a drug that causes birth defects. Due to the reckless nature in which thalidomide was handed out to patients without due care to the effects it had on pregnant women, stricter drug regulation was required.

The amendment was passed against that backdrop. The amendment also carried additional utility, such as:

• Requiring that pharmaceutical manufacturing sites are registered and permit inspections as and when these inspections are needed.
• Placing drug advertising under the remit of FDA supervision.

The Kefauver-Harris amendment, like the Durham-Humphrey amendment above, regularly gets tested; one of the core pharmacy laws to know for the PTCB exam.

For the exam, candidates need to understand why the amendment was passed and what practical solutions it introduced to enhance patient safety.

#3 – Poison Prevention Packaging Act, 1970

The Poison Prevention Packaging Act was enacted to ensure that medicines were child-resistant.

Up to this point, there were no strict regulations in place that mandated pharmaceutical manufacturers to impose child-resistant packaging. This law mandated that all prescription medicines, and most OTC medicines, are contained within child-resistant packaging.

The definition of child-resistant was clear – namely, that it must be sufficiently resistant that at least 80% of children under the age of 5 cannot open it, and that it’s resistant enough that at least 90% of adults can open it.

Of course, this law does not impact some medicines – such as those in nursing homes or hospitals, to which children do not have access. Other drugs that were not required to have non-child resistant packaging include:

• Birth control pills
• Sublingual nitroglycerin tablets
• Potassium effervescent tablets
• Specific corticosteroid tablets

Of course, patients may wish to have non-child resistant containers for their medicines. Pharmacists can provide these containers. Though if they do, a signed release form must be kept on file.

Final Thoughts

We’ve now completed our review of some of the essential pharmacy laws to know for the PTCB exam. We covered the:

• Durham-Humphrey Amendment, 1951
• Kefauver-Harris Amendment, 1963
• Poison Prevention Packaging Act, 1970

Of course, there are far more pieces of legislation to consider. By no means have we exhausted the syllabus of legislation that aspiring pharmacy technicians need to learn.

We will, however, review those other laws and regulations in the coming weeks and months. That’s why it’s essential that you check back to our PTCB blog soon.

If you would like to test your knowledge of PTCB pharmacy laws with complete, full-length answer explanations and practice exams, become a registered member of PTCB Test Prep today.