New guidelines from the FDA will ensure that prescription labels are easier to understand and include messaging about the dangers of abuse.

On July 1, 2019, the Food and Drug Administration issued new prescription label requirements

Medication that will be included under these new rules include those that are categorized under the Controlled Substances Act. Controlled substances are highly potent and potentially addictive medications, including opioids.

The new FDA prescription label requirements will include:

  • Clearer, commonly understood terms
  • Abuse-deterrent information
  • Better patient instructions, including visual elements

The FDA has a history of tracking abuse and providing new standards or guidelines when widespread abuse is evident. This move represents their continued commitment to providing medical caregivers with checks and balances when they prescribe and distribute addictive drugs.  

In their statement detailing this new measure, they state that its intended purpose is to limit addiction, abuse, dependence and tolerance. Providing as much clarity as possible, they allege, will empower pharmacists and other medical professionals with better and more efficient information as they distribute medication.

Drug Abuse and Dependence Section of Labeling

Drug abuse can stem from a variety of factors related to inadequate labeling practices. A study by Friends of Cancer Research found that 56% of the 450 drugs reviewed had uses that extended beyond the FDA label. Supreme Court cases that have addressed labeling have largely relied on evidence of whether manufacturers are at fault for “failure to warn.” 

The elderly and non-English speakers are specifically at risk for unintentionally abusing prescription drugs. Not having clear, straightforward descriptions on medication labels can have fatal consequences.

The Role of Government

The FDA is the branch of the government that sets dispensing guidelines, inspects drugs and conducts research for new drugs. Their approval determines if a drug can be available to consumers, and their recommendations extend to most of the medications people take. 

The Drug Enforcement Administration is the governmental branch that enforces rules and guidelines for the way that prescription drugs are handled in the United States. This includes standards for how drugs are monitored, inventoried, moved as well as prescription guidelines and other dispensing issues. 

The DEA and FDA work in conjunction to create and enact legislation related to drug handling and, in this case, packaging and information. A prescription drug label must include certain information. FDA prescription labeling requirements must be clearly printed with:

  • Pharmacy information
  • Doctor information
  • Instructions
  • Physical description of the drug
  • Federal caution statement
  • Dates
  • Pharmacy prescription number
  • Number of pills
  • Number of times the drug can be reordered

The federal caution is a statement required by the DEA and used to immediately determine if a drug is being used by the person it was prescribed for. Prescription drug warning labels are meant to deter abuse. It is illegal to remove a warning label from a package of prescription drugs.

These new requirements are meant to provide patients with important information, including:

  • Useful and Informative Product Labeling: Product labeling guidelines are in place to help pharmacists and patients immediately understand what the drug is, what it should look like, how much of it to take and other vital information. A human prescription drug label must include all of the legal information set forth by the FDA.
  • Details on Abuse-Deterrent: The information that must be clearly printed on containers of prescription drugs is meant to immediately identify the origin and recipient of the drug, including where and by whom it was prescribed and consumption guidelines. The goal of this measure is to deter abuse and create at least an initial barrier from illicit sharing or selling of prescription drugs.
  • Presentation of Applicable Drug Products: Understanding at a glance what drug is in a package and what it should look like is a helpful way for people who receive prescription drugs to detect mistakes immediately. Drug products are subject to specific labeling. This new measure should serve to make messaging even more clear.

Prescription Label Requirements for Opioid Analgesics

Prescription label requirements are most vital for controlled substances, which are highly addictive and can be abused. One major area of need is opioid reduction protocols. 

When medical providers prescribe opioids for acute pain relief and the prescription runs out, those who have become addicted may to turn to street drugs or take even more extreme measures, such as using heroin, or even committing suicide. 

As of April 1, 2019, the FDA is instituting opioid tapering protocol to help people gradually stop relying on these pain medications. Labeling requirements for prescription drugs that include guidelines for tapering:

  • Help people decrease their opioid use safely. Opioid addiction and dependence can find safe recovery through the gradual discontinuation of opioids. Undergoing an opioid taper program, subject to opioid tapering guidelines, is often the best long-term solution for people who struggle with addiction issues.
  • Reduce the danger of rapid discontinuation. The abrupt discontinuation of opioids can send someone using prescription drugs into a state of shock and acute withdrawal. Desperation and drug-seeking behaviors can follow this extreme experience. Opioid tapering protocol is a proven method to better serve people who have been reliant on opioids. 

Moving Forward

Prescription drug label requirements have the potential to greatly assist people in taking medications safely and correctly. Label requirements that are as universally understandable as possible will help both medical care providers and patients taking prescription drugs. The inclusion of clearer instructions, abuse and diversion deterrent messaging and enhanced visual elements will make understanding and taking opioid medications an easier and safer experience for everyone.

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Editor – Megan Hull
Megan Hull is a content specialist who edits, writes and ideates content to help people find recovery. Read more

Allen, Jeff. “Real World Evidence in Oncology and its implications.” 2011. Accessed August 1, 2019.

Dickenson, Catherine. “Issues and Trends in Drug Product Labeling.” Aspatore Books, 2012. Accessed August 1, 2019.

Drug Enforcement Administration. “Diversion Control Pharmacy Manual.” Accessed August 1, 2019.

Food and Drug Administration. “Code of Federal Regulations Title 21.” April 1, 2018. Accessed August 1, 2019.

Food and Drug Administration. “FDA identifies harm reported from sudden[…]ividualized tapering.” April 1, 2019. Accessed August 1, 2019.

Food and Drug Administration. “Statement on steps to make health care p[…]consistent and clear.” July 1, 2019. Accessed August 1, 2019.

Medical Disclaimer

The Recovery Village aims to improve the quality of life for people struggling with substance use or mental health disorder with fact-based content about the nature of behavioral health conditions, treatment options and their related outcomes. We publish material that is researched, cited, edited and reviewed by licensed medical professionals. The information we provide is not intended to be a substitute for professional medical advice, diagnosis or treatment. It should not be used in place of the advice of your physician or other qualified healthcare providers.