Summary of 
FDA Information:
Approval Date: May 27, 1998

Freedom of 
Information Summary
NADA 065-470 

I. GENERAL INFORMATION: 

NADA 065-470  
Sponsor:  Alpharma, Inc. 
One Executive Drive 
Fort Lee, New Jersey 07024 
Generic Name: bacitracin methylene disalicylate soluble powder 
Trade Name: BMDâ Soluble 
Marketing Status: Over The Counter 
Effect of 
Supplement: This supplement provides for 
the addition of 
a new species, growing quail, to be added to the previously approved product, BMDâ Soluble.


 

II. INDICATIONS FOR USE 


BMDâ Soluble (bacitracin methylene disalicylate soluble powder) is indicated for 
the prevention of 
ulcerative enteritis in growing quail due to Clostridium colinum susceptible to bacitracin methylene disalicylate. 

III. DOSAGE:

A. DOSAGE FORM 
BMDâ Soluble is available in foil packets weighing 4.1 oz (116.2 g). Each packet of 
soluble powder contains 51.2 g bacitracin activity from 
bacitracin methylene disalicylate equivalent to 200 g bacitracin activity per pound or 
to 18,520 units bacitracin (master standard) per gram. 
 
B. ROUTE OF ADMINISTRATION 
Oral, via drinking water 
 
C. RECOMMENDED DOSAGES: 
BMDâ Soluble should be added to clean drinking water at a concentration of 
400mg/gallon.
The medicated water should be provided continuously as the sole source of 
drinking water. Fresh solution should be prepared daily. 
 

IV. EFFECTIVENESS: 


The effectiveness of 
200 g bacitracin methylene disalicylate/ton of 
feed for 
the prevention of 
ulcerative enteritis in growing quail due to Clostridium colinum susceptible to bacitracin methylene disalicylate was 
demonstrated in a supplemental application to NADA 046-592 which 
was 
approved on February17,1989. It has been established in NADA 046-592 and 
NADA 065-470 that x grams of 
bacitracin methylene disalicylate/ton of 
feed is approximately equivalent to 2x mg bacitracin methylene disalicylate/gallon of 
water (e.g.,400mg/gal is equivalent to approximately 200 g of 
feed grade BMD/ton of 
feed). As the effectiveness of 
200 g bacitracin methylene disalicylate per ton of 
feed for 
the prevention of 
ulcerative enteritis in growing quail has been established in the 
approved supplement to NADA 046-592, additional effectiveness studies were 
not required for 
this supplemental application. 

V. ANIMAL SAFETY: 

Bacitracin methylene disalicylate was 
approved on February 17, 1989, (NADA 046-592) for 
use in the 
feed of 
growing quail for 
the prevention of 
ulcerative enteritis due to Clostridium colinum susceptible to bacitracin methylene disalicylate. Based on the margin of 
safety (10X the recommended dosage) previously documented in the 
safety studies summarized for 
use of 
this drug in quail feed, additional safety studies were 
not required for 
this supplemental application. 

VI. HUMAN SAFETY: 

The tolerance for 
residues of 
bacitracin in edible uncooked tissues of 
chickens, turkeys, and 

quail has been established as 0.5 ppm under 
21 CFR 556.70. 


Soluble bacitracin methylene disalicylate is approved for 
chickens and 
turkeys at dosage levels up to 400 mg/gal of 
drinking water. No withdrawal period is required.
The proposed 400 mg/gal level in quail is restricted to growing birds. 


No residues above the tolerance have been observed either at 400 mg/gal use level or 
at 2000 mg/gal level when 
given to chickens or 
turkeys. Based on this experience, residues above the tolerance would not be expected in quail, a related species, when 
added to the drinking water at 400 mg/gal. Consequently, residue studies at this dose level were 
not required for 
quail, a minor species. 

VII. AGENCY CONCLUSIONS: 

The data submitted in support of 
this NADA supplement satisfy the requirements of 
Section 512 of 
the Federal Food, Drug and 
Cosmetic Act and 
21 CFR Part 514 of 
the implementing regulations.
The data demonstrate that bacitracin methylene disalicylate, when 
administered continuously in the 
drinking water of 
growing quail at a concentration of 
400mg/gallon, is safe and 
effective for 
the prevention of 
ulcerative enteritis due to Clostridium colinum susceptible to bacitracin methylene disalicylate.
The tolerance for 
residues of 
bacitracin in edible uncooked tissues of 
chickens, turkeys, and 

quail has been established as 0.5 ppm under 
21 CFR 556.70. Soluble bacitracin methylene disalicylate is approved for 
chickens and 
turkeys at dosage levels up to 400 mg/gal of 
drinking water, and 

no withdrawal period is required. No residues above the tolerance have been observed either at 400 mg/gal use level or 
at 2000 mg/gal level when 
given to chickens or 
turkeys. Based on this experience, residues above the tolerance would not be expected in quail, a related species, when 
added to the drinking water at 400 mg/gal. 


Proper use by lay persons can be expected because the directions are clearly written and 
there is reasonable certainty that the 
conditions of 
use, including mixing directions on the label, can and 
will be followed by the producer.
The agency has concluded that this product can be approved for 
over-the-counter use.
The agency has determined under 
21 CFR 25.33(d)(4) that this action is of 
a type that does not individually or 
cumulatively have a significant impact on the human environment.
Therefore, neither an environmental assessment nor an environmental impact statement is required. 


Under the Center's supplemental approval policy (21 CFR 514.106(b)(2)), these are Category II changes.
The approval of 
these changes is not expected to have any adverse effect on the safety or 
effectiveness of 
this new animal drug and 
, therefore, did not require a reevaluation of 
the human food or 
target animal safety data in the 
parent application. 

VIII. LABELING (Attached) 


A. BMDâ Soluble Foil Packet Label
B. BMDâ Soluble Shipper Label 

Copies of 
applicable labels may be obtained by writing to the: 


Food and 
Drug Administration
Freedom of 
Information Staff (HFI-35)
5600 Fishers Lane
Rockville, MD 20857 

Or requests may be sent via fax to: (301) 443-1726. If there are problems sending a fax, call (301) 443-2414.