The 1982 Tylenol tampering crisis changed pharmaceutical packaging permanently. FDA responded with 21 CFR Part 211.132, mandating tamper-evident packaging for all OTC drug products sold at retail.
More than four decades later, compliance with this regulation remains non-negotiable — and the consequences of a recall, a retailer rejection, or a liability event tied to inadequate tamper evidence are severe.
Pharmaceutical packagers need seals that are reliable, auditable, and consistent across millions of units.
Pharmaceutical Tamper Evident Packaging & OTC Tamper Evident Seals
Here's how Templock helps pharmaceutical and OTC brands protect their products:
How Templock Solves It
Templock has served pharmaceutical manufacturers and contract packagers since before tamper-evidence became federal law.
Our OTC tamper evident seals include efficiently running material designed for liquids, from eye drops to cough and cold remedies. In addition, Templock excels in tamper-evident seals and shrink labels for tablet and capsule bottles and nutraceutical products varying from a single serving to a gallon size supplement powder.
Our differing materials provide lot of options for accommodating containers of all shapes and sizes, as well as low-cost and recycling conscious manufacturers.
For hospital and pharmacy chain supply, where unit-dose and institutional packaging demands are strict, Templock's seals provide the consistent, high-integrity evidence of breach that purchasing and compliance teams require. Every seal we manufacture is produced under documented quality controls, and we can supply material certifications and traceability documentation to support your supplier qualification process.
Compliance
FDA 21 CFR Part 211.132 requires that OTC drug products bear packaging that makes it obvious if the product has been opened or tampered with before purchase. Templock's pharmaceutical tamper-evident packaging meets this standard by providing a seal that is visually distinct, cannot be resealed after removal, and shows clear evidence of disturbance.
Brand Differentiation
Compliance is the floor, not the ceiling. Pharmaceutical brands — particularly OTC consumer health products competing at mass retail — can use custom shrink seals and full-body labels to reinforce brand recognition, carry warning text, and differentiate premium product lines from generic competitors.
Templock's custom label capabilities let you do all of this without compromising the tamper evidence that keeps your compliance intact.
Pharmaceutical tamper evident seals designed to support FDA 21 CFR Part 211.132 requirements
Pre-form and roll stock formats for varied pharmaceutical container profiles
Suitable for hospital and pharmacy chain institutional supply requirements
Custom label options to carry regulatory text, warnings, and brand graphics
Custom label options to carry regulatory text, warnings, and brand graphics
