34852 Federal Register / Vol. 61, No. 129 / Wednesday, July 3, 1996 / Notices

example, pharmacist/veterinarian/client and

VCPR. Rare instances of specialized

compounding to meet emergency needs

would not be considered disproportionate.

B. The following situations would indicate

excessive risk to public health or to animals,

or an otherwise adverse risk/benefit ratio, of

high regulatory priority:

-Instances where illegal residues occur in

meat, milk, eggs, honey, or aquaculture

products and the residues were caused by the

use of a compounded drug in association

with the violation being investigated;

-Compounding of medicaments for foodproducing animals, especially those used in

lactating dairy animals, which cause a

significant risk of illegal residues because, for

example, withholding times have not been

established by the veterinarian using

adequate scientific information; and

-Preparation of drug products that are

essentially similar to products that have been

removed from the market due to regulatory

concerns, for example, chloramphenicol,

dimetridazole, DES in food animals.

C. The following activities would indicate

compounding subject to regulatory action,

and possibly of high regulatory priority.

However, guidance from CVM should be

solicited to assess the potential public health

threat and/or animal safety (i. e., risk vs

benefits).

-Instances where animals have been

harmed or their safety unnecessarily

compromised, such as compounding a

nonsterile product for parenteral or

ophthalmic administration where a sterile

product is indicated, or other instances of not

adhering to good compounding practices.

-Compounded substances that do not bear

the required label information, including the

name of the authorizing veterinarian, the

active ingredients, directions for use,

cautionary statements, and withdrawal times.

D. The following compounding situations

would not ordinarily be considered for

regulatory action. Appropriate state and local

practice and pharmacy laws must be adhered

to, however.

-Compounding for non-food animals and

minor food animal uses where public health

and animal safety have not been threatened,

and are of great need and small risk. This

would include such common practices as:

veterinarians’ combining agents for

anesthesia, large volume parenterals,

preparing appropriate dosage-forms for the

size of the patient in question, ‘‘animal-side’’

compounding, and other similar common

practices that are widely accepted in the day

to day treatment of animal patients.

-Compounding from bulk drug substances

for use in nonfood animals, including

animals in public and private aquaria, when

animal health is not threatened, and there is

not a significant risk of diversion of the bulk

drugs or compounded drugs for use in food

animals. Bulk drug substances would

ordinarily be expected to be in small

packages that meet or exceed USP standards;

see definition of ‘‘bulk drugs’’ above.

Compounding should be performed in

accordance with current standards of

pharmaceutical practice (including referral to

compendial monographs or established

pharmacy textbooks).

If circumstances exist on a case-by-case

basis that indicate otherwise, the Field

should request guidance from CVM before

considering regulatory action. The preceding

is not intended to be a complete list of

activities relating to compounding; there may

be other factors which are appropriate when

assessing an individual case.

Guidance for Charging Violations:

A warning letter is ordinarily the first

choice of action, when referral to state

authorities is not appropriate. Injunction

would be the usual choice of court action,

although seizure should be considered in the

case of high priority drugs such as

chloramphenicol or DES intended for use in

food animals. Criminal action can be

considered in egregious situations.

Compounded drugs subject to regulatory

action under this policy will ordinarily be

charged as unapproved new animal drugs,

violative under Section 501(a)(5). Deviations

from GCP, if not subject of state action will

ordinarily be charged under Section

501(a)(2)(b). The tissue residue violations are

covered under Section 402(a)(2)(D).

Dated: June 26, 1996.

Gary Dykstra,

Acting Associate Commissioner for

Regulatory Affairs.

[FR Doc. 96–16973 Filed 7–2–96; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 96F–0184]

Life Technologies, Inc.; Filing of Food

Additive Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that Life Technologies, Inc., has filed a

petition proposing that the food additive

regulations be amended to provide for a

change in the level of reactants for

sulphopropyl cellulose ion-exchange

resin for the recovery and purification of

proteins for food use.

DATES: Written comments on the

petitioner’s environmental assessment

by August 2, 1996.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Andrew D. Laumbach, Center for Food

Safety and Applied Nutrition (HFS–

217), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–418–3071.

SUPPLEMENTARY INFORMATION: Under the

Federal Food, Drug, and Cosmetic Act

(sec. 409(b)(5) (21 U.S.C. 348(b)(5))),

notice is given that a food additive

petition (FAP 6A4500) has been filed by

Life Technologies, Inc., 8400 Helgerman

Ct., Gaithersburg, MD 20874. The

petition proposes to amend the food

additive regulations in § 173.25 Ionexchange resins (21 CFR 173.25) to

provide for a change in the level of the

reactants for sulphopropyl cellulose ionexchange resin for the recovery and

purification of proteins for food use.

The amendment proposes that the

amount of epichlorohydrin plus

propylene oxide employed does not

exceed 250 percent by weight of the

starting quantity of cellulose. The

current regulation provides that the

amount of epichlorohydrin plus

propylene oxide employed does not

exceed 61 percent by weight of the

starting quantity of cellulose.

The potential environmental impact

of this action is being reviewed. To

encourage public participation

consistent with regulations promulgated

under the National Environmental

Policy Act (40 CFR 1501.4(b)), the

agency is placing the environmental

assessment submitted with the petition

that is the subject of this notice on

display at the Dockets Management

Branch (address above) for public

review and comment. Interested persons

may, on or before August 2, 1996,

submit to the Dockets Management

Branch (address above) written

comments. Two copies of any comments

are to be submitted, except that

individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document. Received

comments may be seen in the office

above between 9 a.m. and 4 p.m.,

Monday through Friday. FDA will also

place on public display any

amendments to, or comments on, the

petitioner’s environmental assessment

without further announcement in the

Federal Register. If, based on its review,

the agency finds that an environmental

impact statement is not required and

this petition results in a regulation, the

notice of availability of the agency’s

finding of no significant impact and the

evidence supporting that finding will be

published with the regulation in the

Federal Register in accordance with 21

CFR 25.40(c).

Dated: May 31, 1996.

Alan M. Rulis,

Director, Office of Premarket Approval,

Center for Food Safety and Applied Nutrition.

[FR Doc. 96–16975 Filed 7–2–96; 8:45 am]

BILLING CODE 4160–01–F