Compounding Pharmacy FDA inspections

[crazyhaha]

I am considering going down the TRT and Trimix road, but I am concerned about compounding pharmacies and the safety of the products.

I like researching things...so I found this:

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm339771.htm

And also this table of inspections, although I don't know why there are two different sites.

http://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/pharmacycompounding/ucm378645.htm

You can see FDA inspection results as well as "warning letters" when the inspections resulted in significant problems. Some warnings seem scary, others not as much.

Just thought I'd share.

 

[Nelson Vergel]

Empower Pharmacy just got FDA approved as a 503B facility to meet all sterility and safety standards. They ship to all states.

Watch this short video of their construction: https://www.youtube.com/watch?v=9Do3LR3FM3M

 

[Sean Mosher]

Ditto on Empower Pharmacy.
Did the tour last week and the place is incredible.

If you're considering TRT, I would urge you to go with a specialist.
There are several endorsed by this site.
I personally use PrimeBody and would love to answer any questions you may have.
Feel free to PM me!

 

[maxadvance]

Looks like noones perfect, geez,

http://www.fda.gov/downloads/AboutF...cy/ORA/ORAElectronicReadingRoom/UCM478202.pdf

DURING AN INSPECTION OF YOUR FIRM WE OBSERVED:

OBSERVATION 1 "'·:".
There is a failure to thoroughly review the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.

Specifically, the sterility test dated 9/10/15 which was conducted by your contract laboratory determined that Lipo-C Injectable, lot # 17478 (Production date: 8112/15, Beyond Use Date: 1/31/16) was not sterile. Subsequent speciation via dated 9/22/15 which was also performed by the contract laboratory determined that the contaminating organism was Streptomyces galbus. An investigation performed by the contracting laboratory dated 9/3/15 documented that the source of the contamination was caused by "external error". A second sample tested for sterility from the same lot passed sterility testing.

There was no documentation of an investigation by your firm into the initial failing sterility result or potential impact on lots of injectable drug products produced on the same date. For example, the following lots of injectable drug products were also produced on 8/12/15:

•••Glutathione, 200mg/ml, lot#17477
GHRP-2/GHRP-6/Sermorelin,lot # 17475
GHRP-2/GHRP-6/Sermorelin,lot #17473

OBSERVATION 2

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process.

A) Media Fills

SOP #T08.06 entitled, ''Sterile Compounding Process Validation " (Undated) documents, in part, that a total of[EJI*- will be used to conduct media fills.

1) Review of media fills conducted between 8/4/14 and 10/2/15 revealed that the media fills were not representative of actual production processes in that:

a. The media fills failed to simulate a lot with the maximum number of vials (i.e. (b) (4 )vials)b.

The number and type of interventions was not included (i.e. breaks in processing to clean up spillage)c. The aseptic assembly of equipment (e.g., at start-up, during processing) was not included.

d. The preparation/formulation of the API was not simulated.
2) Media fills for lyophilized products were not conducted (i.e. Human Chorionic Gonadotropin and Sermorelin)

B)Sterilizationto sterilize rubber stoppers, caps, andalcohol" tun.u;:n..uJ documents thathas not been performed to rt"'.'""'a""'t"'(b ) (4)
D ) LyophilizerYour firm utilizes a for the lyophilization of injectable drug products.Your firm failed to drug products such as Human ChorionicGonadotropin Lyophilized and Sermorelin used.

 

[Nelson Vergel]

Looks like noones perfect, geez,

http://www.fda.gov/downloads/AboutF...cy/ORA/ORAElectronicReadingRoom/UCM478202.pdf

DURING AN INSPECTION OF YOUR FIRM WE OBSERVED:

OBSERVATION 1 "'·:".
There is a failure to thoroughly review the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.

Specifically, the sterility test dated 9/10/15 which was conducted by your contract laboratory determined that Lipo-C Injectable, lot # 17478 (Production date: 8112/15, Beyond Use Date: 1/31/16) was not sterile. Subsequent speciation via dated 9/22/15 which was also performed by the contract laboratory determined that the contaminating organism was Streptomyces galbus. An investigation performed by the contracting laboratory dated 9/3/15 documented that the source of the contamination was caused by "external error". A second sample tested for sterility from the same lot passed sterility testing.

There was no documentation of an investigation by your firm into the initial failing sterility result or potential impact on lots of injectable drug products produced on the same date. For example, the following lots of injectable drug products were also produced on 8/12/15:

•••Glutathione, 200mg/ml, lot#17477
GHRP-2/GHRP-6/Sermorelin,lot # 17475
GHRP-2/GHRP-6/Sermorelin,lot #17473

OBSERVATION 2

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process.

A) Media Fills

SOP #T08.06 entitled, ''Sterile Compounding Process Validation " (Undated) documents, in part, that a total of[EJI*- will be used to conduct media fills.

1) Review of media fills conducted between 8/4/14 and 10/2/15 revealed that the media fills were not representative of actual production processes in that:

a. The media fills failed to simulate a lot with the maximum number of vials (i.e. (b) (4 )vials)b.

The number and type of interventions was not included (i.e. breaks in processing to clean up spillage)c. The aseptic assembly of equipment (e.g., at start-up, during processing) was not included.

d. The preparation/formulation of the API was not simulated.
2) Media fills for lyophilized products were not conducted (i.e. Human Chorionic Gonadotropin and Sermorelin)

B)Sterilizationto sterilize rubber stoppers, caps, andalcohol" tun.u;:n..uJ documents thathas not been performed to rt"'.'""'a""'t"'(b ) (4)
D ) LyophilizerYour firm utilizes a for the lyophilization of injectable drug products.Your firm failed to drug products such as Human ChorionicGonadotropin Lyophilized and Sermorelin used.

Report from 2015 in old small facility

 

[PAUL-E]

looking into TRT I ran across a lot of info on some of the steroid forums and there are guys making their own injectable testosterone in their kitchen without problems now I do not recommend this but considering it I feel pretty safe getting my medications from a compounding pharmacy considering the sterol environment quality materials.

 

[madman]

CANADIAN COMPOUNDING PHARMACYS................absolutely shame full for patients to have to use under dosed hormones that are so critical to ones health!


http://www.ncbi.nlm.nih.gov/pubmed/25963000

 

[CoastWatcher]

CANADIAN COMPOUNDING PHARMACYS................absolutely shame full for patients to have to use under dosed hormones that are so critical to ones health!


http://www.ncbi.nlm.nih.gov/pubmed/25963000

I have no doubt that similar results could be obtained in the US - depending on the pharmacy sample.