[Federal Register Volume 62, Number 152 (Thursday, August 7, 1997)]
[Notices]
[Pages 42595-42599]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-20787]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration
[Docket No. 96-45]


Rick's Pharmacy, Inc., Continuation of Registration With 
Restrictions

    On August 29, 1996, the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration (DEA), issued an 
Order to Show Cause to Rick's Pharmacy, Inc., (Respondent) of Clayton, 
New Mexico, notifying it of an opportunity to show cause as to why DEA 
should not revoke its DEA Certificate of Registration, BR0924440, under 
21 U.S.C. 824 (a)(2) and (a)(4), and deny any pending applications for 
registration as a retail pharmacy under 21 U.S.C. 823(f), for reason 
that its owner/pharmacist has been convicted of a controlled substance 
related felony offense and that its continued registration would be 
inconsistent with the public interest.
    By letter dated September 5, 1996, Respondent, through counsel, 
filed a timely request for a hearing. In the midst of prehearing 
proceedings, Respondent's counsel filed a motion to withdraw as 
counsel, which was granted. Thereafter, Respondent was represented by 
Rick Balzano, the principal shareholder and pharmacist of Respondent. A 
hearing was held in Santa Fe, New Mexico on February 5, 1997, before 
Administrative Law Judge Gail A. Randall. At the hearing, both parties 
called witnesses and introduced documentary evidence. After the 
hearing, Government counsel submitted proposed findings of fact, 
conclusions of law and argument, and Respondent submitted a letter 
setting forth its position. On May 16, 1997, Judge Randall issued her 
Opinion and Recommended Ruling, recommending that Respondent's 
registration be continued subject to certain conditions. On June 6, 
1997, Government counsel filed exceptions to the Opinion and 
Recommended Ruling of the Administrative Law Judge, and on June 18, 
1997, Judge Randall transmitted the record of these proceedings, 
including the Government's exceptions to the Acting Deputy 
Administrator.
    The Acting Deputy Administrator has considered the record in its 
entirety, and pursuant to 21 CFR 1316.67, hereby issues his final order 
based upon findings of fact and conclusions of law as hereinafter set 
forth. the Acting Deputy Administrator adopts, except as specifically 
noted below, the Opinion and Recommended Ruling of the Administrative 
Law Judge. His adoption is in no manner diminished by any recitation of 
facts, issues and conclusions herein, or of any failure to mention a 
matter of fact or law.
    The Acting Deputy Administrator finds that Rick Balzano purchased 
Respondent pharmacy with his parents in 1987. Mr. Balzano is the 
president and pharmacist-in-charge of Respondent, his father is the 
vice president and his mother is the secretary and treasurer. In 
addition to Respondent pharmacy, there is only one other retail 
pharmacy and one hospital pharmacy in Clayton, New Mexico, with the 
next closest pharmacy approximately 82 miles from Clayton. Mr. Balzano 
is one of only two pharmacists practicing in Clayton.
    On October 6 and 7, 1992, New Mexico Board of Pharmacy inspectors 
went to Respondent pharmacy to conduct a routine inspection and audit 
of controlled substances. According to Mr. Balzano, by the time the 
inspectors arrived at the pharmacy at 4:00 p.m. on the first day, he 
had already consumed approximately 50 controlled substance pills.
    The audit covered the period from January 6, 1991 to October 6, 
1992, and revealed overages and shortages for all of the audited 
substances. Significantly, Respondent could not account for 19,394 
dosage units of Lortab 7.5 mg.; 8,201 dosage units of phentermine 30 
mg.; 2,100 dosage units of ``Darvon Compound-65 generic''; 1,430 dosage 
units of Halcion 0.25 mg.; 1,121 dosage units of temazepam 30 mg.; 
1,546 dosage units of clorazepate 7.5 mg.; 1,244 dosage units of 
diazepam 10 mg.; 2,800 dosage units of Roxicet; and 1,397 dosage units 
of Tylox. Significant overages, where Respondent could account for more 
of a drug than it was accountable for include, 1,521 dosage units of 
Darvon-N-100; 1,606 Wygesic generic; and 1,994 Tranxene 3.75 mg.
    On October 28, 1992, the inspectors went to Respondent pharmacy to 
return the records used in conducting the audit and to discuss the 
audit with Mr. Balzano. At that time, Mr. Balzano

[[Page 42596]]

admitted that he had a drug abuse problem. Mr. Balzano testified at the 
hearing in this matter that his tolerance to the drugs built up to the 
point that he could ingest more than 50 pills per day. He admitted to 
personally taking a number of the missing controlled substances, 
including lorazepam, Ativan, Dalmane, flurazepam, Fastin, phentermine, 
Halcion, Restoril, temazepam, Valium, diazepam, Xanax, Lorcet, Lortab, 
Vicodin, Dexedrine, Percodan, Roxiprin, Percocet, Roxicet, and Tylox. 
However, Mr. Balzano denied taking the remaining substances that were 
unaccounted for during the audit period. He suggested at the hearing 
that had he been given an opportunity to explain the audit 
discrepancies, the overages and shortages may have balanced each other 
out based upon the dispensing of a generic substance when a brand name 
substance had been prescribed or based upon the potential labeling or 
mislabeling of the substances.
    During the investigation, the New Mexico Board of Pharmacy 
inspectors discovered several prescriptions apparently issued by a 
local dentist for Mr. Balzano and other patients. The dentist denied 
writing any of the prescriptions for Mr. Balzano, and Mr. Balzano 
ultimately admitted that he had forged several of the dentist's 
prescriptions. Mr. Balzano also admitted filling prescriptions that had 
been issued by the dentist for individuals for the stimulant drugs, 
phentermine and Fastin. In addition, the inspectors discovered 16 
prescriptions for Fastin for an individual that were allegedly written 
by a local physician. The physician denied writing these prescriptions, 
and Mr. Balzano admitted at the hearing in this matter to improperly 
dispensing the drugs. Finally, the investigation revealed several 
prescriptions for family members allegedly authorized by Mr. Balzano's 
brother who is a dentist. Dr. Balzano indicated to the inspectors that 
he had not authorized some of these prescriptions, and Mr. Balzano 
testified that he now understands that he should not have dispensed 
these controlled substances.
    Mr. Balzano testified that after the inspectors were at Respondent 
pharmacy in early October 1992, he began his recovery efforts from drug 
addiction, and has not improperly taken any controlled substances since 
October 28, 1992. Which he began his recovery efforts on his own, in 
March 1993, he entered a local treatment center where he stayed for 
three weeks, during which time he closed Respondent pharmacy and 
informed the community of his drug abuse problem.\1\ Following his in-
patient treatment, Mr. Balzano signed a two-year voluntary contract 
with the Pharmacists' Recovery Network Committee of New Mexico (PRN) 
which required at least 12 random urine screens a year, attendance at 3 
to 4 Alcoholics Anonymous or Narcotics Anonymous meetings per week, and 
attendance at monthly PRN meetings in Albuquerque, New Mexico. During 
the term, of the contract, Mr. Balzano underwent 22 random urine 
screens, and all were negative. According the PRN, Mr. Balzano complied 
with all the requirements of the contract. Following the expiration of 
the contract in March 1995, Mr. Balzano remained an active member of 
the PRN.
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    \1\ In her opinion and Recommended Ruling, the Administrative 
Law Judge indicated that Respondent pharmacy remained closed for 
three months, however, Mr. Balzano testified that the pharmacy was 
closed for three weeks.
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    As a result of the investigation, information was filed in the 
United States District Court for the District of New Mexico, charging 
that Mr. Balzano knowingly and intentionally acquired 60 Lortab 7.5 mg. 
tablets, a Schedule III controlled substance, by forging the local 
dentist's name to a prescription in violation of 21 U.S.C. 843(a)(3). 
Thereafter, in March 1994, following Mr. Balzano's entering a plea of 
guilty, he was convicted of the felony offense of acquiring or 
obtaining a controlled substance by forgery, deception or subterfuge in 
violation of 21 U.S.C. 843(a)(3). Mr. Balzano was sentenced to two 
years probation, and on August 31, 1995, he was granted early 
termination of probation due to satisfactory behavior.
    In August 1996, New Mexico Board of Pharmacy inspectors conducted 
another inspection at Respondent pharmacy. The inspector who testified 
at the hearing in this matter indicated that the following violations 
were revealed: (1) A required reference book, and the New Mexico 
Pharmacy Laws and Regulations were not on the premises; (2) a required 
``Purchaser's Statement'' was missing from the exempt narcotic book; 
(3) the time of day was not properly recorded on the 1996 inventory; 
and (4) the practitioner's DEA registration number was not recorded on 
several prescription forms. The inspectors did not conduct an audit of 
controlled substances during this inspection. According to the 
inspector, the noted violations were corrected and Respondent pharmacy 
has been in compliance with these requirements since the August 1996 
inspection.
    Following a formal hearing on January 28, 1997, the New Mexico 
Board of Pharmacy (Board) issued a decision on February 24, 1997, 
regarding Mr. Balzano's pharmacist license. The Board found inter alia, 
that Mr. Balzano was the pharmacist-in-charge of Respondent; that the 
1992 inspection revealed shortages of Schedule II, III and IV 
controlled substances; that Mr. Balzano was convicted in March 9, 1994 
in the United States District Court of the District of New Mexico of 
one count of acquiring or obtaining a controlled substance by forgery, 
deception or subterfuge, and was sentenced to two years probation with 
conditions; that Mr. Balzano completed his probation and program with 
the PRN; and that Mr. Balzano admitted that he had a substance abuse 
problem and had the drugs for his own use. As a result, the Board 
placed Mr. Balzano on probation for two years, and his pharmacist's 
license was suspended for two years with all but 28 days held in 
abeyance pending successful completion of the probationary period. In 
addition, the Board ordered Mr. Balzano to sign a new five year 
contract with the PRN; to not dispense any controlled substances to 
himself or to his immediate family members; an to notify the Board of 
any personal controlled substance prescription ``with a copy of the 
prescription attached and a note from the prescribing authority that 
the prescription is medically indicated.'' Finally, the Board noted 
that, ``[i]f it comes to the attention of the Board that [Mr. Balzano] 
was violated the terms and conditions of probation, [Mr. Balzano's] 
license to practice will be immediately suspended pending a hearing 
before the Board.''
    Respondent entered into evidence affidavits from the administrator 
of the local hospital, the president of a local bank, the chairman of 
the PRN, the assistant director of the PRN, several physicans, 
including the local dentist whose name Mr. Balzano had forged on the 
prescription for Lortab, and others. These individuals attested to Mr. 
Balzano's professional integrity and to the community's need for the 
continued operation of Respondent pharmacy.
    The Deputy Administrator may revoke or suspend a DEA Certificate of 
Registration under 21 U.S.C. Sec. 824(a), upon a finding that the 
registrant:
* * * * *
    (2) Has been convicted of a felony under this subchapter or 
subchapter II of this chapter or any other law of the United States, 
or of any State relating to any substance defined in this subchapter 
as a controlled substance;
* * * * *
    (4) Has committed such acts as would render his registration 
under section 823 of

[[Page 42597]]

this title inconsistent with the public interest as determined under 
such section;
* * * * *
    It is undisputed that Mr. Balzano was convicted on March 9, 1994, 
of a felony violation of 21 U.S.C. 843(a)(3). It is well settled that a 
pharmacy operates under the control of owners, stockholders, 
pharmacists or other employees, and if any such person is convicted of 
a felony offense related to controlled substances, grounds exist to 
revoke the pharmacy's registration under 21 U.S.C. 824(a)(2). See 
Maxicare Pharmacy, 61 FR 27,368 (1996); Big-T Pharmacy, Inc., 47 FR 
51,830 (1982). Therefore, the Acting Deputy Administrator concurs with 
Judge Randall's conclusion that the Government has proven by a 
preponderance of the evidence that grounds exist to revoke Respondent's 
registration under 21 U.S.C. 824(a)(2), based upon the controlled 
substance related felony conviction of its owner/pharmacist, Mr. 
Balzano.
    Pursuant to 21 U.S.C. Secs. 823(f) and 824(a)(4), the Deputy 
Administrator may also revoke a DEA Certificate of Registration and 
deny any pending applications, if he determines that the continued 
registration would be inconsistent with the public interest. Section 
823(f) requires that the following factors be considered:
    (1) The recommendation of the appropriate State licensing board or 
professional disciplinary authority.
    (2) The applicant's experience in dispensing, or conducting 
research with respect to controlled substances.
    (3) The applicant's conviction record under Federal or State laws 
relating to the manufacture, distribution, or dispensing of controlled 
substances.
    (4) Compliance with applicable State, Federal, or local laws 
relating to controlled substances.
    (5) Such other conduct which may threaten the public health or 
safety. These factors are to be considered in the disjunctive; the 
Deputy Administrator may rely on any one or a combination of factors 
and may give each factor the weight he deems appropriate in determining 
whether a registration should be revoked or an application for 
registration be denied. See Henry J. Schwarz, Jr., M.D., Docket No. 88-
42, 54 FR 16,422 (1989). In this case, all five factors are relevant.
    As to factor one, it is undisputed that on February 24, 1997, the 
New Mexico Board of Pharmacy issued a decision placing Mr. Balzano on 
probation for two years and suspending his pharmacist license for two 
years with all but 28 days held in abeyance pending successful 
completion of the probationary period. As terms of his probation, the 
Board ordered Mr. Balzano to sign a five year contract with the PRN, 
prohibiting him from dispensing controlled substances to himself or to 
immediate family members, and required him to notify the Board if he 
obtained any personal controlled substance prescriptions.
    Factors two and four, respondent's experience in dispensing 
controlled substances and compliance with state, Federal or local laws 
relating to controlled substances, are relevant in determining the 
public interest. The 1992 audit results which revealed significant 
overages and shortages of Schedule II-IV controlled substances 
indicated at the very least a failure to maintain complete and accurate 
records as required by 21 U.S.C. 827. However, Mr. Balzano admitted to 
diverting many of the missing drugs for his personal use in violation 
of under 21 U.S.C. 843(a)(3). Although Mr. Balzano admitted to having a 
drug abuse problem, he denied taking a significant number of the 
unaccounted for controlled substances. The Acting Deputy Administrator 
concurs with Judge Randall's finding that Mr. Balzano ``failed to 
provide a persuasive explanation for these shortages.''
    Mr. Balzano admitted to other instances of improper dispensing of 
controlled substances. He admitted to forging several prescriptions for 
his personal use with the name of the local dentist in violation of 21 
U.S.C. 829 and 843(a)(3). He admitted to filling prescriptions for 
Fastin/phentermine issued by a dentist not in the usual course of 
professional practice in violation of 21 U.S.C. 829 and 21 CFR 1306.04. 
Finally, he admitted to dispensing controlled substances to family 
members and to another individual without the appropriate authorization 
from a practitioner in violation of 21 U.S.C. 829 and 841.
    The subsequent state audit conducted in 1996 revealed the following 
state regulatory violations: a required reference book and the New 
Mexico Pharmacy Laws and Regulations were not on the premises; a 
statement was missing in the exempt narcotic book; the time of day was 
not recorded on the 1996 inventory, and the practitioner's DEA 
registration number was not on several prescription forms.\2\ Failure 
to record the time of the day on the inventory was also a violation of 
21 CFR 1304.11, and failure to place the practitioner's DEA 
registration on prescriptions was also a violation of 21 CFR 1306.05. 
The Acting Deputy Administrator disagrees with Judge Randall's finding 
that ``although the 1996 Board inspection found administrative 
discrepancies, none of these errors involved the handling of controlled 
substances.'' Failure to note the time on a controlled substance 
inventory and failure to place a practitioner's DEA registration on 
prescriptions clearly are violations that relate to the handling of 
controlled substances. However, the Acting Deputy Administrator notes 
that since the 1996 inspection, Respondent has been in compliance with 
these requirements.
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    \2\ The Government asserts that the inspection also revealed 
that Respondent failed to have controlled substance invoices readily 
retrievable. However, the testimony of the inspector at the hearing 
in this matter did not specifically address Respondent's failure to 
comply with this requirement of the state regulations.
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    As to factor three, it is undisputed that Mr. Balzano, Respondent's 
owner/pharmacist was convicted in March 1994 of one count of acquiring 
or obtaining controlled substances by misrepresentation, fraud, 
forgery, deception, or subterfuge in violation of 21 U.S.C. 843(a)(3), 
as a result of his forging a local dentist's name to a prescription for 
Lortab in order to obtain controlled substances for his own use. As 
discussed previously, a pharmacy's registration may be revoked on the 
basis of the owner/pharmacist's felony conviction relating to 
controlled substances.
    Regarding factor five, Mr. Balzano admitted that he had a substance 
abuse problem for a number of years. Further, he admitted that he 
diverted a significant amount of controlled substances from the 
pharmacy for his own use. A number of the missing drugs however, remain 
unaccounted for following the 1992 audit. The Acting Deputy 
Administrator agrees with Judge Randall and the Government, ``that the 
public health and safety was placed at risk by Mr. Balzano's lack of 
judgment and concern for the precision needed by a pharmacist to 
properly fill prescriptions for patients relying on his 
professionalism.''
    The Government has proven by a preponderance of the evidence that 
grounds exist to revoke Respondent pharmacy's DEA registration under 21 
U.S.C. 824(a)(4). However, like Judge Randall, the Acting Deputy 
Administrator finds that while ``Respondent's evidence in mitigation 
does not justify or excuses the misconduct of Mr. Balzano, [it is] 
significant and credible that he admitted to the extensive scope of his 
previous drug addiction and to his misconduct that flowed from his 
illness, to include the forging of prescriptions.'' Mr. Balzano last 
improperly used controlled

[[Page 42598]]

substances in October 1992. He has undergone extensive rehabilitation 
treatment which will now continue until the year 2002 in light of the 
Board's recent decision requiring him to enter into a five year 
contract with the PRN.
    It is significant that beyond diverting drugs from the pharmacy for 
his own use, Mr. Balzano forged prescriptions, and improperly dispensed 
controlled substances to his family members and others. In addition, 
the other shortages and overages revealed by the 1992 audit have yet to 
be explained. However, Mr. Balzano testified at the hearing in this 
matter that, ``I did some things when I was on drugs that I just cannot 
believe that I did them. You're a different person when you're on these 
drugs. I can't explain some of the things I did or why I did them.''
    As noted above, Mr. Balzano has been free from drugs since October 
1992, and Respondent has continued in operation since 1992 with no 
allegations of improper handling of controlled substances other than 
the several violations found during the August 1996 inspection which 
have since been corrected. Previously, DEA has held that while a lapse 
in time since the wrongdoing is not dispositive, it is a factor to be 
considered. See Norman Alpert, M.D., 58 FR 67,420 (1993). In this case, 
it is significant that since the 1992 inspection, Mr. Balzano has 
undergone extensive treatment for his drug addiction, has remained 
drug-free, has accepted responsibility for his past misconduct, and has 
essentially remained in compliance with the laws and regulations 
relating to controlled substances. In addition, as Judge Randall noted 
that should Respondent's DEA registration be revoked, ``the residents 
of Clayton, New Mexico will be left with only one retail pharmacy * * * 
[and] will either have to use this pharmacy or travel 82 miles to the 
next closest pharmacy.''
    Judge Randall concluded ``that the public interest will best be 
served by allowing the Respondent to continue with its Certificate of 
Registration with certain conditions'' beyond those required by the 
Board's decision. Judge Randall recommended that Respondent shall 
comply with the following terms for three years from the effective date 
of the final order:
    (1) submit to the local DEA office a copy of the Respondent's 
state-required annual inventory;
    (2) submit to the local DEA office the results of any audit or 
inspection conducted upon the Respondent by the Board; and
    (3) notify the local DEA office within 5 work days in the event the 
New Mexico Pharmacy Board reinstates the suspension of Mr. Balzano's 
license. Judge Randall further recommended that ``[i]n the event Mr. 
Balzano ceases to work as the Respondent's pharmacist, the Respondent 
may apply to DEA to have these conditions removed from its Certificate 
of Registration.''
    The Government filed exceptions to the Administrative Law Judge's 
Opinion and Recommended Ruling, arguing that the Administrative Law 
Judge failed to ``make a finding with respect to unexplained controlled 
substance shortages which were not alleged to have been consumed by 
Respondent's pharmacist,'' The Government argued that ``at a minimum, 
Respondent and pharmacist Balzano failed to keep complete and accurate 
records. * * *'' The Government further contended that the ``evidence 
of Mr. Balzano's activity with regard to unlawful distribution of 
controlled substances by falsified prescriptions * * * could support an 
inference that other missing controlled substances were also 
diverted.'' The Acting Deputy Administrator finds that the 
Administrative Law Judge, in considering factors two, four and five, 
did in fact find that Mr. Balzano did not provide a persuasive 
explanation for the missing drugs other than those he admitted to 
consuming. The Acting Deputy Administrator agrees with the Government's 
contention, that at a minimum, these shortages represent faulty 
recordkeeping. However, the Acting Deputy Administrator rejects the 
Government's argument that the evidence presented supports an inference 
that the missing drugs were diverted. While Mr. Balzano admitted that 
several forged prescriptions were filled and that controlled substances 
were improperly dispensed on several occasions, there was no evidence 
presented at the hearing which would warrant a finding that the 
unexplained shortages were the result of diversion.
    The Government also argued in its exceptions that Judge Randall's 
``recommended action in this matter is a departure from prior agency 
practice and policy.'' In support of its argument, the Government cited 
to several cases where a pharmacy's DEA registration was revoked based 
upon the improper dispensing of controlled substances and the 
conviction of the pharmacist for a felony offense relating to 
controlled substances. See Farmacia Ortiz, 61 FR 726 (1996); Dellmar 
Pharmacy #4, 59 FR 46,066 (1994); and Nasir Gore, T/A All Drugs 
Pharmacy, Inc., 59 FR 60,661 (1994). The Acting Deputy Administrator 
recognizes that the DEA registrations of these pharmacies were in fact 
revoked, however these cases can be distinguished from the instant 
proceeding. In this case, Respondent's owner/pharmacist admitted to a 
serious drug abuse problem which caused his misconduct. Mr. Balzano has 
accepted responsibility for his past behavior and has undergone 
extensive rehabilitation. He has been drug-free since October 1992, and 
will continue to be monitored by the PRN for a number of years. In 
addition, Respondent pharmacy has continued in operation since 1992 
with no evidence of violations of a similar nature to those revealed by 
the 1992 inspection. Therefore, the Acting Deputy Administrator does 
not find that the Administrative Law Judge's recommendation to continue 
Respondent's registration subject to certain restrictions is a 
departure from prior agency practice. The Acting Deputy Administrator 
concludes that it is in the public interest to continue Respondent's 
registration in light of the foregoing, as well as the need for 
Respondent pharmacy in the community.
    Nevertheless, the Acting Deputy Administrator does concur with the 
Government's contention that if Respondent's registration is to be 
continued, the restrictions imposed on its registration should more 
directly address the nature of Respondent's misconduct, than those 
restrictions recommended by Judge Randall. Mr. Balzano suffered from a 
serious drug abuse problem causing him to divert controlled substances 
from the pharmacy for his own use, to improperly dispense controlled 
substances to others, and at the very least, to fail to maintain 
complete and accurate records of controlled substances. Consequently, 
the Acting Deputy Administrator concludes that Respondent's 
registration shall be subject to the following conditions:
    (1) If Mr. Balzano's contract with the PRN is terminated before the 
expiration of the five year term, Mr. Balzano shall continue to undergo 
random urinalysis at his own expense no less than one time per month 
for the original term of the contract. Results of these urine screens 
shall be submitted to the DEA office in Albuquerque, New Mexico.
    (2) If Mr. Balzano's contract with the PRN is terminated before the 
expiration of the five year term, Mr. Balzano shall be prohibited from 
dispensing controlled substances to himself or members of his immediate 
family for the original term of the contract.
    (3) For three years from the effective date of this final order, 
Respondent shall undergo an annual audit of

[[Page 42599]]

controlled substances conducted by an independent auditor hired by 
Respondent. Results of these audits shall be forwarded to the DEA 
office in Albuquerque, New Mexico.
    (4) Respondent shall notify the local DEA office in Albuquerque, 
New Mexico within 5 work days in the event the New Mexico Pharmacy 
Board reinstates the suspension of Mr. Balzano's pharmacist license.
    Accordingly, the Acting Deputy Administrator of the Drug 
Enforcement Administration, pursuant to the authority vested in him by 
21 U.S.C. 823 and 824, and 28 CFR 0.100(b) and 0.104, hereby orders 
that DEA Certificate of Registration, BR0924440, issued to Rick's 
Pharmacy, Inc., be continued, and any pending applications for renewal 
be granted, subject to the above described restrictions. This order is 
effective September 8, 1997.

    Dated: July 31, 1997.
James S. Milford,
Acting Deputy Administrator.
[FR Doc. 97-20787 Filed 8-6-97; 8:45 am]
BILLING CODE 4410-09-M