Your medicine, explained
Labels, pill changes, generic vs brand, and using medicines safely. 23 articles: 18 explainers, 4 how-to guides, 1 history.
Generic or brand
Extended-release, delayed-release and immediate-release pills, and how FDA judges their generics
ER, XL, DR and the rest describe how a pill lets go of its drug. What the formulations are, how FDA tests generic copies of each, what the Orange Book codes say, and what our recall data show.
State generic substitution laws
Whether a pharmacist must, may or may not swap in a generic is set by state law. How mandatory and permissive states differ, what consent and notice rules require, and where the Orange Book fits.
Store-brand OTC medicines
The two legal routes OTC medicines take to the shelf, what the 2020 CARES Act changed about monographs, why store brands carry the same active ingredients, and where to read Drug Facts.
The pharmacist's role in generic substitution
What a pharmacist checks before swapping in a generic: the Orange Book code, the prescriber's instructions, state rules for narrow therapeutic index drugs, and the counseling duty set by OBRA '90.
What a generic must share with its brand, and what can differ
FDA fixes a generic's active ingredient, strength, form, route and absorption. Fillers, dyes, shape and price can vary. How the rules work, and how to look up one product's ingredients on DailyMed.
Why your pill changed color
Pharmacies buy the same generic from different manufacturers, and each makes its tablet look different. How the required imprint code identifies a pill, and what research found about appearance changes and refills.
Labels & identifiers
Boxed warnings, FDA's most prominent label warning, explained
What 21 CFR 201.57 requires of a boxed warning, how many prescription labels carry one (about a third, by two counts 14 years apart), and why a generic's box matches the brand's.
How to read a Drug Facts label
Every OTC medicine carries the same panel, in the same order, under a 1999 FDA rule. A heading-by-heading guide to 21 CFR 201.66, worked through on a generic ibuprofen 200 mg label.
Pill imprint codes and the 1993 rule behind them
Since September 1995, nearly every US tablet and capsule must carry a code identifying the drug, its strength and its maker. What 21 CFR 206 requires, who is exempt, and where imprint data live now.
What 'USP' after a drug name means
The three letters point to a public quality standard that federal law makes binding. What a USP monograph covers, who writes and enforces it, and why the letters are the maker's claim and no seal of testing.
What "Rx only" on a drug label means
The symbol traces to a 1951 amendment and a 1997 rewrite of federal drug law. How a drug lands on either side of the prescription line, and how molecules from loratadine to naloxone crossed it.
Where the lot number and expiration date sit on a medicine package
What federal rules require of the lot number and expiration date, how they fit into the DSCSA 2D barcode, and why recalls are organized around them.
How to look up a drug on DailyMed
DailyMed is the National Library of Medicine's free archive of drug labels as companies submit them to FDA. How to search it by name or NDC, find inactive ingredients and imprints, and tell the leaflets apart.
How to read a prescription label
Which fields federal law requires, which come from your state, how the Rx number differs from the NDC, where lot numbers live, and the 12-digit NDC change set for 2033.
Medication Guides and patient package inserts
What 21 CFR Part 208 requires, when a pharmacy must hand over a Medication Guide, how patient package inserts differ, and where FDA's one-page replacement proposal stands.
The NDC number explained, from 10 digits to 12
The National Drug Code's three segments and three 10-digit formats, how it becomes 11 digits for billing, how to look one up, and FDA's 2026 rule moving every NDC to 12 digits in 2033.
Using medicines safely
Look-alike and sound-alike drug names, and how FDA tries to keep them apart
How FDA screens new drug names with its POCA software, why generic names can resemble each other, how tall man lettering works, and what recall records show about mix-ups.
Scored tablets and what the label says about them
Since 2013, FDA has reserved the phrase "functional scoring" for tablets tested to split evenly. Where that wording appears on a prescription label, what sits behind it, and how often it shows up in FDA's data.
The 1970 law behind child-resistant medicine caps
How the Poison Prevention Packaging Act of 1970 came about, how CPSC tests a child-resistant package, and what federal studies found about its effect on child poisoning deaths.
Unit-dose and blister packaging, from hospital carts to dose packs
How unit-dose systems spread through US hospitals, what FDA requires on unit-dose and blister labels, the six-month dating rule for repackaged doses, and how blister packs fail.
What the storage instructions on a medicine label mean
How federal rules tie a label's storage line to its expiration date, what USP terms like controlled room temperature mean in degrees, and what FDA recall records show about storage failures.
How drug expiration dates are set
What the expiration date on a medicine means under federal rules, how stability testing produces it, what the federal Shelf Life Extension Program found, and when FDA has allowed use past labeled dates during shortages.
How to dispose of unused medicines
The order of options FDA recommends, from DEA take-back sites and mail-back envelopes to the short flush list and household trash, and what each one accepts.