[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR558.274]

[Page 411-413]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS--Table of Contents
 
      Subpart B--Specific New Animal Drugs for Use in Animal Feeds
 
Sec.  558.274  Hygromycin B.

    (a) Approvals. (1) Type A medicated articles: 2.4 and 8 grams per 
pound to 000986 in Sec.  510.600(c) of this chapter for use as in 
paragraph (c) of this section.
    (2) 2.4 grams per pound to 043733 in Sec.  510.600(c) of this 
chapter for use in swine feed as in paragraph (c)(1)(ii) of this 
section.
    (3) [Reserved]
    (4) 0.6 gram per pound to 017790, 043733, and 050639 in Sec.  
510.600(c) of this chapter for use in chickens as in paragraph (c)(1)(i) 
of this section and in swine as in paragraph (c)(1)(ii) of this section.
    (5)-(6) [Reserved]
    (7) 2.4 grams per pound to 017519 in Sec.  510.600(c) of this 
chapter for use in chickens as in paragraph (c)(1)(i) and in swine as in 
paragraph (c)(1)(ii) of this section.
    (8) 0.6 and 1.6 grams per pound granted to 046573 in Sec.  
510.600(c) of this chapter for use in chickens as in paragraph (c)(1)(i) 
and in swine as in paragraph (c)(1)(ii) of this section.
    (b) Related tolerances. See Sec.  556.330 of this chapter.
    (c) Conditions of use. (1) It may be used as follows:

----------------------------------------------------------------------------------------------------------------
  Hygromycin B in grams per     Combination in grams
             ton                      per ton            Indications for use         Limitations        Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 8 to 12.................  .......................  Chickens: control of    Withdraw 3 days before    000986,
                                                        infestation of large    slaughter.               017519,
                                                        roundworms (Ascaris                              017790,
                                                        galli), cecal worms                              043733,
                                                        (Heterakis gallinae),                            046573,
                                                        and capillary worms                               050639
                                                        (Capillaria
                                                        obsignata).
                              Bacitracin 100.........  Chickens; control of    As bacitracin           .........
                                                        infestation of large    methylene
                                                        roundworms (Ascaris     disalicylate or zinc
                                                        galli), cecal worms     bacitracin; withdraw
                                                        (Heterakis gallinae),   3 days before
                                                        and capillary worms     slaughter.
                                                        (Capillaria
                                                        obsignata); treatment
                                                        of chronic
                                                        respiratory disease
                                                        (airsac infection),
                                                        blue comb
                                                        (nonspecific
                                                        infectious enteritis).
                              Bacitracin plus          1. Chickens; control    Feed containing not     .........
                               penicillin (100 to 200   of infestation of       less than 25% of
                               of combination).         large roundworms        penicillin plus not
                                                        (Ascaris galli),        less than 50% of
                                                        cecal worms             bacitracin; as
                                                        (Heterakis gallinae),   procaine penicillin
                                                        and capillary worms     plus bacitracin
                                                        (Capillaria             methylene
                                                        obsignata); treatment   disalicylate;
                                                        of chronic              withdraw 3 days
                                                        respiratory disease     before slaughter.
                                                        (airsac infection),
                                                        blue comb
                                                        (nonspecific
                                                        infectious enteritis).
                                                       2. Chickens; control    Combination containing  .........
                                                        of infestation of       not less than 50% nor
                                                        large roundworms        more than 75% of
                                                        (Ascaris galli),        bacitracin, except
                                                        cecal worms             that it contains not
                                                        (Heterakis gallinae),   more than 125 g of
                                                        and capillary worms     penicillin; as
                                                        (Capillaria             procaine penicillin
                                                        obsignata); treatment   plus zinc bacitracin;
                                                        of chronic              withdraw 3 days
                                                        respiratory disease     before slaughter.
                                                        (airsac infection),
                                                        blue comb
                                                        (nonspecific
                                                        infectious enteritis).

[[Page 412]]


                                                       3. Chickens, control    Combination containing  .........
                                                        of infestation of       50% to 75%
                                                        large roundworms        bacitracin, but not
                                                        (Ascaris galli),        more than 125 g of
                                                        cecal worms             penicillin, as
                                                        (Heterakis gallinae),   procaine penicillin;
                                                        and capillary worms     withdraw 3 days
                                                        (Capillaria             before slaughter..
                                                        obsignata); treatment
                                                        of chronic
                                                        respiratory disease
                                                        (airsac infection),
                                                        blue comb
                                                        (nonspecific
                                                        infectious enteritis).
                              Chlortetracycline 100    Chickens; control of    Do not feed to          .........
                               to 200.                  infestation of large    chickens producing
                                                        roundworms (Ascaris     eggs for human
                                                        galli), cecal worms     consumption; feed for
                                                        (Heterakis gallinae),   7 to 14 days;
                                                        and capillary worms     withdraw 3 days
                                                        (Capillaria             before slaughter.
                                                        obsignata); control
                                                        of infectious
                                                        synovitis caused by
                                                        Mycoplasma synoviae
                                                        susceptible to
                                                        chlortetracycline.
                              Chlortetracycline 200    Chickens; control of    ......do..............  .........
                               to 400.                  infestation of large
                                                        roundworms (Ascaris
                                                        galli), cecal worms
                                                        (H. Gallinae), and
                                                        capillary worms
                                                        (Capillaria
                                                        obsignata); control
                                                        of chronic
                                                        respiratory disease
                                                        (CRD) and air sac
                                                        infection caused by
                                                        Mycoplasma
                                                        gallisepticum and
                                                        Escherichia coli
                                                        susceptible to
                                                        chlortetracycline.
                              Penicillin 100.........  Chickens; control of    As procaine             .........
                                                        infestation of large    penicillin; withdraw
                                                        roundworms (Ascaris     3 days before
                                                        galli), cecal worms     slaughter.
                                                        (Heterakis gallinae),
                                                        and capillary worms
                                                        (Capillaria
                                                        obsignata); treatment
                                                        of chronic
                                                        respiratory disease
                                                        (airsac infection),
                                                        blue comb
                                                        (nonspecific
                                                        infectious enteritis).
                              Tylosin 4 to 50........  Chickens: Control of    As tylosin phosphate;      000986
                                                        infestations of large   withdraw 3 days
                                                        roundworms (Ascaris     before slaughter.
                                                        galli), cecal worms
                                                        (Heterakis
                                                        gallinae,), and
                                                        capillary worms
                                                        (Capillaria
                                                        obsignata); growth
                                                        promotion and feed
                                                        efficiency.
(ii) 12.....................  .......................  Swine: control of       Withdraw 15 days          000986,
                                                        infestation of large    before slaughter.        017519,
                                                        roundworms (Ascaris                              017790,
                                                        suis), nodular worms                             043733,
                                                        (Oesophagostomum                                 046573,
                                                        dentatum), and                                    050639
                                                        whipworms (Trichuris
                                                        suis).
                              Chlortetracycline 400..  Swine; control of       Withdraw 15 d before    .........
                                                        infestation of large    slaughter..
                                                        roundworms (Ascaris
                                                        suis), nodular worms
                                                        (Oesophagostomum
                                                        dentatum) and
                                                        whipworms (Trichuris
                                                        suis); treatment of
                                                        bacterial enteritis
                                                        caused by E. coli and
                                                        Salmonella
                                                        choleraesuis and
                                                        bacterial pneumonia
                                                        caused by P.
                                                        multocida susceptible
                                                        to chlortetracycline..
                              Tylosin 10 to 100......  Swine: Control of       As tylosin phosphate;      000986
                                                        infestations of large   withdraw 15 days
                                                        roundworms (Ascaris     prior to slaughter;
                                                        suis), nodular worms    feed continuously as
                                                        (Oesophagostomum        follows:.
                                                        dentatum), and         Animal wt.(lbs.):.....
                                                        whipworms (Trichuris    Up to 40........20 to
                                                        suis); growth           100\1\.
                                                        promotion and feed      41 to 100........20
                                                        efficiency.             to 40\1\.
                                                                                101 to market
                                                                                wt........10 to 20\1\.
----------------------------------------------------------------------------------------------------------------
\1\ Amount of Tylosin (g/t).


[[Page 413]]

    (2) Hygromycin B may also be used in combination with:
    (i) Amprolium in accordance with Sec.  558.55.
    (ii) Zoalene in accordance with Sec.  558.680.

[41 FR 11000, Mar. 15, 1976]

    Editorial Note: For Federal Register citations affecting Sec.  
558.274, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and on GPO Access.