19596 Federal Register / Vol. 60, No. 75 / Wednesday, April 19, 1995 / Notices

of Source Plasma. This revocation

notice affects only the Douglas

Plasmalab, Douglas, AZ, facility and has

no bearing on other establishment and

product licenses issued to Plasmalab

Donor Centers, Inc. In a letter to FDA

dated March 28, 1994, the firm

requested that the establishment and

product licenses issued to its Douglas

Plasmalab, Douglas, AZ, facility be

revoked and thereby waived its

opportunity for a hearing on the matter.

DATES: The revocation of the

establishment license (U.S. License No.

1072–001) and product license became

effective June 8, 1994.

FOR FURTHER INFORMATION CONTACT:

Timothy W. Beth, Center for Biologics

Evaluation and Research (HFM–635),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448, 301–594–3074.

SUPPLEMENTARY INFORMATION: FDA has

revoked the establishment license (U.S.

License No. 1072–001) and the product

license for the manufacture of Source

Plasma issued to Plasmalab Donor

Centers, Inc., doing business as Douglas

Plasmalab at 11 J Ave., Douglas, AZ

85607.

FDA inspected Douglas Plasmalab at

11 J Ave., Douglas, AZ, from February

10, 1994, through March 9, 1994,

following the report by the

establishment of an error from the

reinfusion of the wrong red blood cells

to a donor undergoing plasmapheresis.

The inspection revealed serious

deviations from Federal regulations.

FDA has determined that these

deviations constitute a danger to health.

These deficiencies included, but were

not limited to, the following: (1) Failure

to follow procedures designed to

prevent the infusion of one donor’s red

blood cells into another donor (21 CFR

640.65(b)(3)); (2) failure to follow

procedures designed to prevent

contamination of red blood cells for

reinfusion (21 CFR 640.64(e)); (3) failure

to limit the frequency of Source Plasma

donation to two times within a 7-day

period (21 CFR 640.65(b)(5)); (4) failure

to maintain accurate and concurrent

records to document the performance of

each significant step in the collection,

processing, and storage of each unit of

blood and blood components (21 CFR

606.160); and (5) failure to maintain

adequate and complete standard

operating procedures that are available

to personnel in the areas where the

procedures are performed for all steps in

the collection, processing, storage, and

distribution of Source Plasma (21 CFR

606.100(b)). The inspection indicated

serious noncompliance with the donor

protection standards which are intended

to assure a continuous and healthy

donor population, as well as with

standards designed to assure the

continued safety, purity, potency, and

quality of products manufactured.

In addition to the inspection, the

agency conducted a concurrent

investigation that involved interviews

with individuals knowledgeable of the

daily operations of Douglas Plasmalab.

This investigation revealed that

deviations routinely occurred in

important areas of the plasmapheresis

operation. These deviations included,

but were not limited to, the following:

Maintenance of inaccurate red blood

cell reinfusion records, forced and

unfiltered reinfusion of whole blood

into donors whose donation of blood

exceeded the legally allowable limit,

and reinfusion of red blood cells which

may have been contaminated through a

break in the closed sterile system of

collection.

FDA concluded that the serious

nature of the deficiencies noted during

the inspection and concurrent

investigation at Douglas Plasmalab was

a direct consequence of the

establishment’s disregard for the

applicable regulations and standards in

the license applications and constitutes

a danger to public health warranting

suspension pursuant to 21 CFR 601.6(a).

In a letter to the firm dated March 17,

1994, FDA suspended and confirmed

telephone notice of the suspension of

the establishment license (U.S. License

No. 1072–001) and the product license

for Source Plasma. In a letter to FDA

dated March 28, 1994, Plasmalab Donor

Centers, Inc., voluntarily requested that

its Douglas Plasmalab licenses be

revoked and thereby waived its

opportunity for a hearing. The agency

granted the request by letter to the firm

dated, June 8, 1994, which revoked the

establishment license (U.S. License No.

1072–001) and the product license for

the manufacture of Source Plasma.

FDA has placed copies of the letters

relevant to the license revocation on file

under the docket number found in

brackets in the heading of this

document with the Dockets

Management Branch (HFA–305), Food

and Drug Administration, rm. 1–23,

12420 Parklawn Dr., Rockville, MD

20857. These documents are available

for public examination in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

Accordingly, under 21 CFR 601.5,

section 351 of the Public Health Service

Act (42 U.S.C. 262), and under authority

delegated to the Commissioner of Food

and Drugs (21 CFR 5.10) and

redelegated to the Director, Center for

Biologics Evaluation and Research (21

CFR 5.68) the establishment license

(U.S. License No. 1072–001) and the

product license for the manufacture of

Source Plasma issued to Plasmalab

Donor Centers, Inc., Douglas, AZ, were

revoked, effective June 8, 1994.

This notice is issued and published

under 21 CFR 601.8 and the

redelegation at 21 CFR 5.67.

Dated: April 8, 1995.

Kathryn C. Zoon,

Director, Center for Biologics Evaluation and

Research.

[FR Doc. 95–9578 Filed 4–18–95; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 94N–0298]

Putnam County Blood Bank, Inc.;

Revocation of U.S. License No. 1121

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

revocation of the establishment license

(U.S. License No. 1121) and the product

licenses issued to Putnam County Blood

Bank, Inc., (PCBB) for the manufacture

of Whole Blood, Red Blood Cells,

Platelets, and Plasma. In a letter to FDA

dated April 29, 1994, the firm requested

that its establishment and product

licenses be revoked and thereby waived

its opportunity for a hearing on the

matter.

DATES: The revocation of the

establishment license (U.S. License No.

1121) and product licenses became

effective June 3, 1994.

FOR FURTHER INFORMATION CONTACT:

Timothy W. Beth, Center for Biologics

Evaluation and Research (HFM–635),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448, 301–594–3074.

SUPPLEMENTARY INFORMATION: FDA

conducted an inspection of PCBB, 2919

Kennedy St., Palatka, FL 32077, from

September 1, 1992, through October 6,

1992. The inspection revealed serious

deviations from Federal regulations.

FDA determined these deviations to

constitute a danger to public health.

These deficiencies included, but were

not limited to, the following: (1) Failure

to establish scientifically sound and

appropriate specifications, standards,

and test procedures to assure that blood

and blood components are safe, pure,

potent, and effective (21 CFR 606.140(a)

and 610.45(c)), and (2) failure to

institute systems capable of precluding

release of unsuitable blood and blood

components (21 CFR 640.3(b) and (c)

and 606.160(b)(1)(ii) and (e)).
Federal Register / Vol. 60, No. 75 / Wednesday, April 19, 1995 / Notices 19597

Because of these serious deviations,

FDA concluded that the management at

PCBB did not adequately demonstrate

the ability to operate the establishment

in a manner that assured compliance

with Federal regulations or accepted

standard operating procedures, or to

ensure that personnel were adequately

trained and supervised and had a

thorough understanding of the

procedures that they performed as

required by 21 CFR 600.10(a) and (b)

and 606.20(a) and (b). These conditions

at PCBB were considered to constitute a

danger to public health warranting

license suspension pursuant to 21 CFR

601.5(b) and 601.6(a). FDA accordingly

suspended the firm’s licenses by letter

dated November 6, 1992.

In addition to the suspension of

establishment and product licenses, and

in order to preclude the distribution of

violative units, and to address those

questionable units already in

distribution channels, FDA requested

that PCBB immediately and

concurrently perform the following: (1)

Review test records for antibody to the

human immunodeficiency virus (Type

I), and then identify and defer all donors

who may have been misinterpreted as

suitable due to improper donor reentry

procedures; (2) develop and implement

a plan to identify and defer all donors

who, during the medical history

interview, have provided information

which may deem such donors as

ineligible, and (3) identify and recall all

units collected from such donors, and

notify all consignees of transfusible and

nontransfusible blood and blood

components of the test/medical history

of the units. In a letter to the firm dated

March 9, 1994, FDA concluded that the

recall was complete.

In a letter to FDA dated April 29,

1994, PCBB voluntarily requested that

its licenses be revoked and thereby

waived its opportunity for a hearing.

The agency granted the request in a

letter dated June 3, 1994, which revoked

the establishment and product licenses.

FDA has placed copies of the letters

relevant to the license revocation on file

under the docket number found in

brackets in the heading of this

document with the Dockets

Management Branch (HFA–305), Food

and Drug Administration, rm. 1–23,

12420 Parklawn Dr., Rockville, MD

20857. These documents are available

for public examination in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

Accordingly, under 21 CFR 601.5,

section 351 of the Public Health Service

Act (42 U.S.C. 262), and under authority

delegated to the Commissioner of Food

and Drugs (21 CFR 5.10) and

redelegated to the Director, Center for

Biologics Evaluation and Research (21

CFR 5.68), the establishment license

(U.S. License No. 1121) and the product

licenses for the manufacture of Whole

Blood, Red Blood Cells, Platelets, and

Plasma issued to Putnam County Blood

Bank, Inc., Palatka, FL, were revoked,

effective June 3, 1994.

This notice is issued and published

under 21 CFR 601.8 and the

redelegation at 21 CFR 5.67.

Dated: April 11, 1995.

Kathryn C. Zoon,

Director, Center for Biologics Evaluation and

Research.

[FR Doc. 95–9577 Filed 4–18–95; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 95N–0090]

Dietary Supplements: Notice of

Withdrawal of Regulatory Guidance

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that it has withdrawn a number of

import alerts, import bulletins, and

compliance policy guides involving

dietary supplements. FDA has taken

these actions to conform its regulatory

guidance to the changes made to the

Federal Food, Drug, and Cosmetic Act

(the act) by the Dietary Supplement

Health and Education Act (DSHEA).

FOR FURTHER INFORMATION CONTACT:

Loretta A. Branch Carey, Center for

Food Safety and Applied Nutrition

(HFS–456), Food and Drug

Administration, 200 C Street SW.,

Washington, DC 20204, 202–205–5372.

SUPPLEMENTARY INFORMATION: On

October 25, 1994, the President signed

into law the DSHEA (Pub. L. 103–417).

Among the most significant changes in

the act made by the DSHEA is the

addition of section 201(s)(6) (21 U.S.C.

321(s)(6)), which excepts dietary

ingredients of dietary supplements from

coverage under the food additive

provisions of the act (section 3(b) of the

DSHEA). As a result of this change, such

ingredients are no longer subject to a

premarket safety review.

In response to this change, FDA has

reviewed the regulatory guidance that it

issues to its field offices to conform that

guidance to the change. As a result of

this review, FDA has found that it is

appropriate to withdraw the following

import alerts, import bulletins, and

compliance policy guides because they

are no longer consistent with the act.

A. Compliance Policy Guides

1. CPG 7117.04, entitled ‘‘Botanical

Products for use as Food’’

2. CPG 7118.01, entitled ‘‘Dietary

Supplements-Misbranding Nutritionally

Insignificant Ingredients’’

B. Import Alerts

1. 24–14 Products containing Bracken

2. 26–02 Flaxseed/Linseed Oil

3. 54–03 Carnitine

4. 54–05 Ultra Bios 2000 Food Supplement

5. 66–02 Ginseng

6. 66–04 Oil of Evening Primrose

C. Import Bulletins

1. 31–B01 Selfheal Flower, Prunella

Vulgaris

2. 54–B06 Tricosanthis

3. 66–B62 Ephedra

The Agency continues to review and

revise the remaining related import

alerts, bulletins, and compliance policy

guides, in order to comply with DSHEA.

FDA notes that it does not usually

give notice in the Federal Register of its

issuance or withdrawal of import alerts

or bulletins. It is doing so in this

instance, however, because of the ongoing congressional interest in FDA’s

implementation of the DSHEA. FDA

advises that issuing this notice does not

mark any type of change in the agency’s

usual procedures for issuing or

withdrawing these alerts or bulletins.

In response to the DSHEA, FDA has

also reassessed its general enforcement

priorities with respect to dietary

supplements. FDA advises that in

enforcing the act with respect to these

products, its primary focus is likely to

be, as it always has been, on safety

concerns. The agency advises, however,

that its regulatory priorities are subject

to adjustment in response to changing

circumstances. For example, the

labeling of dietary supplements will

likely be given a higher priority by the

agency after December 31, 1996, when

compliance with FDA’s nutrition

labeling and nutrient content claim

regulations for dietary supplements is to

begin.

Dated: April 13, 1995.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 95–9702 Filed 4–18–95; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 84N–0102]

Cumulative List of Orphan-Drug and

Biological Designations

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.