12 replies to this topic

[bettyjaneqa]

I work for a small chocolate candy manufacture and our GMPs have always included the statement, "Prescription medicine is not allowed in production area, must be locked in locker only. No medicine of any kind can be left out in lunch room. " An employee asked to have their inhaler close to them. I was wondering if changing our GMPs to allow inhalers or other emergency prescribed medication would be allowed in food production areas for both SQF and FDA requirements. 

[kconf]

No.

[Setanta]

Seconded No. 

[kfromNE]

I highly doubt their inhaler is with them at all times even at home. Locker room should be close enough or they could leave one with the Employee Safety Director or HR especially in a small facility

 

If a person is having an asthma attack, they'll need to be off the floor anyway. 

Edited by kfromNE, 05 August 2024 - 03:33 PM.

[bettyjaneqa]

No.

Can you point me to a code or statement to show how this unacceptable? I have looked for restrictions but did not see any and my searching only finds requirements for prescription manufactures. My boss wants to see proof this cannot change.

[kconf]

I work for a small chocolate candy manufacture and our GMPs have always included the statement, "Prescription medicine is not allowed in production area, must be locked in locker only. No medicine of any kind can be left out in lunch room. " An employee asked to have their inhaler close to them. I was wondering if changing our GMPs to allow inhalers or other emergency prescribed medication would be allowed in food production areas for both SQF and FDA requirements. 

Why have your GMPs always included the statement? 

[kconf]

Isn't it part of your food safety plan? Why would you want to modify your plan and compromise with food safety? 

[Setanta]

Can you point me to a code or statement to show how this unacceptable? I have looked for restrictions but did not see any and my searching only finds requirements for prescription manufactures. My boss wants to see proof this cannot change.

 

 

I don't think this is a change. An inhaler would be a prescription medication. It needs to be restricted.

Edited by Setanta, 05 August 2024 - 04:08 PM.

[kfromNE]

Can you point me to a code or statement to show how this unacceptable? I have looked for restrictions but did not see any and my searching only finds requirements for prescription manufactures. My boss wants to see proof this cannot change.

 

It falls under GMPs and physical contaminants. Potentially chemical if it were to be accidently sprayed in the plant (dropped). You're opening Pandora's box if you allow emergency prescription medicine in food production areas. Like what counts as an emergency. Inhalers are used not just for emergency use. Tylenol is used for emergency use. Candy is used for diabetics for low blood sugar. The list goes on. 

 

Side note: If someone is having an asthma attack, you want that person out of the production area (the area that caused the asthma attack). 

[SQFconsultant]

Hi Betty, if an employee needs to have an inhaler at all times, that employee should not be working in production. This is a big can of worms that I have witnessed go bad very quickly. There is no upside, the risks are all down. No changes to the GMPs, otherwise you'll have all sorts of exceptions happening. 

[jfrey123]

FDA GMP and SQF code don't explicitly call out any directives regarding prescription medications, neither for nor against.  They both prohibit personal items in areas where food is handled or exposed.  This is one area where regulators and auditors will push back.

 

The inhaler also becomes unregistered brittle plastic that is not metal detectable.  Employee accidentally drops it into machinery and you've got a hazard that affects your customers, and there's no guarantee the employee will notice or properly follow their training to inform you due to fear of disciplinary action.  Some overzealous auditor could make arguments about it being an uncontrolled/uninventoried chemical.  Others could point out that once you allow one rx medication, your case for limiting other rx's is weaker, and ex's floating around on the floor become a source of intentional adulteration in contrary to your food defense programs.

 

Now with that said, non-food US regs also requires you to make reasonable accommodations for employees with medical conditions.  If you're going to employee them in production, you have to find something reasonable despite prohibitions in other sections of US law.  Either they should be moved outside of active production, or some type of secured but accessible storage that allows them to use at a safe distance away from the exposed food could be safe enough for SQF purposes.  Add some written direction that they are required to go rewash hands if they leave the line to use the inhaler, as well as accounting for whatever else you can think of.

 

It's a tough spot, and I'd opt to move them employee to a non-GMP position.

[Lynx42]

Can you point me to a code or statement to show how this unacceptable? I have looked for restrictions but did not see any and my searching only finds requirements for prescription manufactures. My boss wants to see proof this cannot change.

  

It doesn't spell out everything, and I wish it said "including, but not limited to..." to stop some of the arguments I get, but this is the code we reference.

 

FDA 21 CFR 117.10 (b)(9)

(9) Taking any other necessary precautions to protect against allergen cross-contact and against contamination of food, food-contact surfaces, or food-packaging materials with microorganisms or foreign substances (including perspiration, hair, cosmetics, tobacco, chemicals, and medicines applied to the skin).

[Hoosiersmoker]

Medications are all also chemicals which always need to be restricted / prohibited.