Refrigerate MB-12?

[Guest guest]

Hi Dr. McCandless,

This is very, very , very simple.

Methylcobalamin - the raw powder - is to be stored refrigerated, we actually

keep the powder in the freezer.

When we make a batch of the injection, the injection takes several days to

dissolve, we then sterilize the solution thru a 0.22 micron filter inside a

laminar flow hood and the solution is stored in 10-mL vials.

We keep the vials in the refrigerator and protected from light

The vials of methylcobalamin injection have no preservative

When we prepare a prescription for patient, a vial is removed from the

refrigerator and placed in the laminar flow hood. It is allowed to warm to room

temperature, and one of the pharmacist prepared the individual shots required

for that patients prescription.

The patient's prescription of shots is labeled and put in the refrigerator, and

toward the end of the day we begin loading the boxes for shipment of the

prescriptions.

We choose, because of good practice guidelines, to ship the syringes

refrigerated and to label them to be stored in the refrigerator until used. We

advise the parents to remove one of the injections several minutes prior to

dosing because the methylcobalamin injection actually freezes in the

refrigerator.

Any injectable drug dispensed without a preservative should be stored

refrigerated.

This has nothing to do with the stability of the methylcobalamin dissolved in

the solution, it is only a double precaution we insist upon to ensure

STERILITY, not STABILITY.

I believe there is a very low chance that the syringes could become contaminated

- the sterile dose is prepared in a sterile environment and the orange cap that

covers the needle is airtight, however, again, GOOD PHARMACY COMPOUNDING

PRACTICES ARE THAT AN INJECTABLE DRUG WITHOUT A PRESERVATIVE IS TO BE

REFRIGERATED UNTIL USE!!!!!!!!!!!!!!!!!!!!!

Thanks

Tyrus