What to Expect from USP Chapter 1 Labelling Revisions
On December 1, 2013, a revised labelling standard will become effective—the United States Pharmacopeia (USP) General Chapter <1> Injections, Labeling on Ferrules and Cap Overseals (USP 34-NF 29 November 1, 2010) for injectable drug vials. The revised chapter affects all injectable drug products, human and veterinary, intended for sale in the USA.
Markus vor dem Esche of US-headquartered contract manufacturer of drug delivery systems West Pharmaceutical Services offers guidance to pharmaceutical manufacturers seeking to comply with the new standards.
Q: How does the new standard impact pharmaceutical packaging?
A: The revision places limits on what drug manufacturers can print or otherwise display on the top surface of cap overseals and ferrules (aluminum shells) used to secure injectable drug vials. This revised standard is specific to injectable human and veterinary drug products that are intended to be sold in the USA, so even manufacturers based in Europe or Asia Pacific must comply if the product is intended for sale in the USA.
Q: How will the revised chapter affect what can be printed on caps and/or seals?
A: Many pharmaceutical manufacturers currently print or display information on the surface of the plastic cap or seal. Printed information often includes the trade name of the product, company logos or the company name. West also embosses and prints our registered “Flip-Off” name on seals. The revised standard prohibits this type of information, and the USP has specifically cited these examples as messages that can no longer appear on the cap or seal.
In addition, the revised chapter restricts printing to cautionary statements, which are statements intended to prevent an imminent life-threatening situation and may include instructional statements that provide potency or other safety-related instructions if warranted. Cautionary labeling statements must be simple, concise and devoid of non-essential information. Only cautionary statements may appear on the top (circle) surface of the ferrule and/or cap overseal of a vial containing an injectable product. The statement should be printed in a contrasting colour and be clearly visible under ordinary conditions of use. Other statements or features, including but not limited to, identifying numbers or letters, such as code numbers, lot numbers, company names, logos or product names, may appear on the side (skirt) surface of the ferrule but not on the top (circle) surface of the ferrule or cap overseal.
Q: Will any current statements be grandfathered under the revision?
A: It is our understanding that no printing or information displayed on caps or seals is grandfathered by the revised standard. So although their printing or labeling may have been approved in the past, pharmaceutical manufacturers must make sure that it is in compliance with the revised standard.
Q: What should pharmaceutical manufacturers do now to prepare for implementation?
A: It is critical for pharmaceutical manufacturers to understand their inventory depletion plan to ensure that their supply chain is not interrupted. Many manufacturers have large amounts of unused seals in inventory and it takes time for those raw materials to be depleted. It also takes time for packaging component manufacturers like West to produce new seals according to customers’ specifications to be in compliance with the revised standard.
Q: What can pharmaceutical manufacturers do if they wish to retain current printing on the cap or seal?
A: The USP explains that if manufacturers believe there is a need to include a cautionary statement on the ferrule or cap overseal, then the manufacturers must provide a rationale to the FDA for why the situation addressed in the statement is considered to be life threatening. They will need to present the FDA with data and rationale to support that the statement meets the intent of the standard, and is the best message to minimise a potential life-threatening situation.
At West, our regulatory department can provide a customised regulatory technical package to help present additional information and rationale to assist in aligning the ferrule and cap overseal printing with the USP standard. These customised packages were created to provide the rationale denoted in USP Frequently Asked Questions General Chapter <1> Injections, Section on Labeling on Ferrules and Cap Overseals, dated August 4, 2010. USP recommended giving data and information to the FDA for their evaluation and determination for retention of the current printing consistent with the revised USP <1> standard.
More information is available at West’s online resource centre, including the compendial notice from the USP.
Medical Plastics News would like to thank Martin Gleissner of Swedish public relations company MSL Stockholm for arranging this contribution.